FHIR Server FHIR Server Version n/a

Resource StructureDefinition/FHIR Server from package hl7.fhir.us.pq-cmc-fda#current (2547 ms)

Package
hl7.fhir.us.pq-cmc-fda
Type
StructureDefinition
FHIR Version
Source
http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/StructureDefinition-pqcmc-excipient.html
Url
http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
Version
1.1.6
Status
active
Date
2024-09-17T03:56:09+00:00
Name
ExcipientRaw
Title
Excipient Drug Substance
Experimental
False
Realm
Authority
hl7
Description
Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
Type
SubstanceDefinition
Kind
resource
Resources that use this resource

StructureDefinition
cmc-ectd-document-32p32
CMC eCTD 32P32 Document
cmc-ectd-document-32s23
CMC eCTD 32S23 Document
cmc-ectd-document-sp4151
CMC eCTD SP4151 Document
pqcmc-dp-ingredient
Drug Product Batch Formula Ingredient
pqcmc-quality-specification
Quality Specification
Resources that this resource uses

StructureDefinition
cmc-organization
Basic Organization
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
Quality Benchmark Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology
Source Type Terminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification
Substance Classification
Narrative

Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition pqcmc-excipient
Name	Flags	Card.	Type	Description & Constraints
SubstanceDefinition	C	0..*	SubstanceDefinition	The detailed description of a substance, typically at a level beyond what is used for prescribing cmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' cmc-name-isbt: Name.type ISBT 128 required for blood products. cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.
meta
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier		0..1	Identifier	optional user designated identifier
classification	S	1..*	CodeableConcept	Substance Type Binding: Substance Classification (required)
grade		1..1	CodeableConcept	Quality Standard Binding: Quality Benchmark Terminology (required)
manufacturer	S	0..*	Reference(Basic Organization)	The entity that creates, makes, produces or fabricates the substance
supplier	S	0..1	Reference(Basic Organization)	An entity that is the source for the substance. It may be different from the manufacturer
Slices for code	S	1..*	BackboneElement	Codes associated with the substance Slice: Unordered, Open by value:code.coding.system
code:unii		0..1	BackboneElement	UNII
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: http://fdasis.nlm.nih.gov
code:uniProt		0..1	BackboneElement	UniProt ID
code	S	1..1	CodeableConcept	The specific code
coding	S	1..1	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system Required Pattern: https://www.uniprot.org
Slices for name	SC	1..*	BackboneElement	Substance Name Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true
name:All Slices				Content/Rules for all slices
preferred	S	0..1	boolean	True when the name type is Substance Name
name:sub	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	Generic Name
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C97054
display		1..1	string	Representation defined by the system Fixed Value: Generic Name
preferred	S	0..1	boolean	If this is the preferred name for this substance
name:gsrs	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	GSRS Preferred Term
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C203355
display		1..1	string	Representation defined by the system Fixed Value: GSRS Preferred Term
preferred	S	0..1	boolean	If this is the preferred name for this substance
name:isbt	S	0..1	BackboneElement	Names applicable to this substance
name	S	1..1	string	ISBT-128 DIN
type	S	1..1	CodeableConcept	Name type e.g. 'systematic', 'scientific, 'brand'
coding	S	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C95517
display		1..1	string	Representation defined by the system Fixed Value: ISBT-128 DIN
preferred	S	0..1	boolean	If this is the preferred name for this substance
sourceMaterial	S	1..1	BackboneElement	Material or taxonomic/anatomical source
type		1..1	CodeableConcept	Source Type
coding		0..*	Coding	Code defined by a terminology system Binding: Source Type Terminology (required)
genus	S	0..1	CodeableConcept	The genus of an organism e.g. the Latin epithet of the plant/animal scientific name
coding		0..0
text		1..1	string	Source Organism
species	S	0..1	CodeableConcept	Source Organism
coding		0..0
text		1..1	string	Plain text representation of the concept
part	S	0..1	CodeableConcept	Source Organism Part
text	S	1..1	string	Plain text representation of the concept
countryOfOrigin	SC	0..1	CodeableConcept	Source Organism Country of Origin cmc-iso-genc-overlap: Only country codes that are also member of GENC can be used.
coding	S	1..1	Coding	Code defined by a terminology system
code	SC	1..1	code	Symbol in syntax defined by the system cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
Documentation for this format
Source

{
  "resourceType" : "StructureDefinition",
  "id" : "pqcmc-excipient",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition pqcmc-excipient</b></p><a name=\"pqcmc-excipient\"> </a><a name=\"hcpqcmc-excipient\"> </a><a name=\"pqcmc-excipient-en-US\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition\">SubstanceDefinition</a><a name=\"SubstanceDefinition\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-when-unii-required, cmc-name-isbt, cmc-source-material )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/substancedefinition.html\">SubstanceDefinition</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The detailed description of a substance, typically at a level beyond what is used for prescribing</span><br/><span style=\"font-weight:bold\">cmc-when-unii-required: </span>A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'<br/><span style=\"font-weight:bold\">cmc-name-isbt: </span>Name.type ISBT 128 required for blood products.<br/><span style=\"font-weight:bold\">cmc-source-material: </span>IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.meta\">meta</a><a name=\"SubstanceDefinition.meta\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.meta.profile\">profile</a><a name=\"SubstanceDefinition.meta.profile\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">canonical</a>(<a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/structuredefinition.html\">StructureDefinition</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Profiles this resource claims to conform to</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.identifier\">identifier</a><a name=\"SubstanceDefinition.identifier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">optional user designated identifier</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.classification\" title=\"A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.\n[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]\">classification</a><a name=\"SubstanceDefinition.classification\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Substance Type<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-substance-classification.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification\">Substance Classification</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.grade\" title=\"The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard\">grade</a><a name=\"SubstanceDefinition.grade\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Quality Standard<br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-quality-benchmark-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology\">Quality Benchmark Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.manufacturer\">manufacturer</a><a name=\"SubstanceDefinition.manufacturer\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The entity that creates, makes, produces or fabricates the substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_reference.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.supplier\">supplier</a><a name=\"SubstanceDefinition.supplier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">Reference</a>(<a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">An entity that is the source for the substance. It may be different from the manufacturer</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code\">Slices for code</a><a name=\"SubstanceDefinition.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">1</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5; font-style: italic\">Codes associated with the substance</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by value:code.coding.system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii\" title=\"Slice unii: The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substanceâ€™s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/\">code:unii</a><a name=\"SubstanceDefinition.code.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UNII</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code\">code</a><a name=\"SubstanceDefinition.code.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:unii.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">http://fdasis.nlm.nih.gov</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt\" title=\"Slice uniProt: The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/\">code:uniProt</a><a name=\"SubstanceDefinition.code.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UniProt ID</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code\">code</a><a name=\"SubstanceDefinition.code.code.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The specific code</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12401.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code.coding\">coding</a><a name=\"SubstanceDefinition.code.code.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.code:uniProt.code.coding.system\">system</a><a name=\"SubstanceDefinition.code.code.coding.system.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">https://www.uniprot.org</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> <a style=\"font-style: italic\" href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name\" title=\"Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF\">Slices for name</a><a name=\"SubstanceDefinition.name\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-name-preferred )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\"/><span style=\"font-style: italic\">1</span><span style=\"font-style: italic\">..</span><span style=\"opacity: 0.5; font-style: italic\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; font-style: italic\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"font-style: italic\">Substance Name</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Closed by value:type.coding</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">cmc-name-preferred: </span><span style=\"font-style: italic\">Name.preferred: at most one = true</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> name:All Slices<a name=\"SubstanceDefinition.name.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1320.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">True when the name type is Substance Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub\" title=\"Slice sub\">name:sub</a><a name=\"SubstanceDefinition.name.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.name\" title=\"A non-branded nor registered name that meant for common use.\">name</a><a name=\"SubstanceDefinition.name.name\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Generic Name</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.type\">type</a><a name=\"SubstanceDefinition.name.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C97054</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">Generic Name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:sub.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs\" title=\"Slice gsrs\">name:gsrs</a><a name=\"SubstanceDefinition.name.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.name\" title=\"Default display name identified within FDA Global Substance Registration System (GSRS).\">name</a><a name=\"SubstanceDefinition.name.name.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">GSRS Preferred Term</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.type\">type</a><a name=\"SubstanceDefinition.name.type.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding.2\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C203355</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">GSRS Preferred Term</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:gsrs.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt\" title=\"Slice isbt\">name:isbt</a><a name=\"SubstanceDefinition.name.5\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Names applicable to this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.name\" title=\"It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]\">name</a><a name=\"SubstanceDefinition.name.name.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ISBT-128 DIN</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.type\">type</a><a name=\"SubstanceDefinition.name.type.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Name type e.g. 'systematic',  'scientific, 'brand'</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12501.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.type.coding\">coding</a><a name=\"SubstanceDefinition.name.type.coding.3\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">At least the following</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system\">system</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#uri\">uri</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Identity of the terminology system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Symbol in syntax defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">C95517</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_fixed.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Fixed Value\" class=\"hierarchy\"/> <a href=\"http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Representation defined by the system<br/><span style=\"font-weight: bold\">Fixed Value: </span><span style=\"color: darkgreen\">ISBT-128 DIN</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slice.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.name:isbt.preferred\">preferred</a><a name=\"SubstanceDefinition.name.preferred.4\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#boolean\">boolean</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">If this is the preferred name for this substance</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial\">sourceMaterial</a><a name=\"SubstanceDefinition.sourceMaterial\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/types.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Material or taxonomic/anatomical source</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.type\" title=\"A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type \">type</a><a name=\"SubstanceDefinition.sourceMaterial.type\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Type</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.type.coding\">coding</a><a name=\"SubstanceDefinition.sourceMaterial.type.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-pqcmc-source-type-terminology.html\" title=\"http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology\">Source Type Terminology</a> (<a href=\"http://hl7.org/fhir/R5/terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">required</a>)</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.genus\">genus</a><a name=\"SubstanceDefinition.sourceMaterial.genus\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">The genus of an organism e.g. the Latin epithet of the plant/animal scientific name</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"text-decoration:line-through\">coding</span><a name=\"SubstanceDefinition.sourceMaterial.genus.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.genus.text\" title=\"The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.\">text</a><a name=\"SubstanceDefinition.sourceMaterial.genus.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.species\" title=\"The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.\">species</a><a name=\"SubstanceDefinition.sourceMaterial.species\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0110.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span style=\"text-decoration:line-through\">coding</span><a name=\"SubstanceDefinition.sourceMaterial.species.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"text-decoration:line-through\"/><span style=\"text-decoration:line-through\">0</span><span style=\"text-decoration:line-through\">..</span><span style=\"text-decoration:line-through\">0</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.species.text\">text</a><a name=\"SubstanceDefinition.sourceMaterial.species.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck011.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.part\" title=\"A fragment of the source organism. [Source: SME Defined]\nExamples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.\nIDMP 11238 definition &amp; examples: Entity of anatomical origin of source material within an organism.\nCartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal \">part</a><a name=\"SubstanceDefinition.sourceMaterial.part\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Part</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.part.text\">text</a><a name=\"SubstanceDefinition.sourceMaterial.part.text\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Plain text representation of the concept</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.countryOfOrigin\" title=\"The name of the country where the organism was reared. [Source: SME Defined]\">countryOfOrigin</a><a name=\"SubstanceDefinition.sourceMaterial.countryOfOrigin\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-iso-genc-overlap )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span>..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Source Organism Country of Origin<br/><span style=\"font-weight:bold\">cmc-iso-genc-overlap: </span>Only country codes that are also member of GENC can be used.</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0001.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.countryOfOrigin.coding\">coding</a><a name=\"SubstanceDefinition.sourceMaterial.countryOfOrigin.coding\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#Coding\">Coding</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Code defined by a terminology system</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-pqcmc-excipient-definitions.html#SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code\">code</a><a name=\"SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R5/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( cmc-only-ISO-3166-1-alpha-3 )\">C</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R5/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Symbol in syntax defined by the system</span><br/><span style=\"font-weight:bold\">cmc-only-ISO-3166-1-alpha-3: </span>Country must be a 3 letter country code</td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.42.27"
    }
  ],
  "version" : "1.1.6",
  "name" : "ExcipientRaw",
  "title" : "Excipient Drug Substance",
  "status" : "active",
  "date" : "2024-09-17T03:56:09+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [
    {
      "name" : "HL7 International / Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system" : "email",
          "value" : "brr@lists.HL7.org"
        }
      ]
    }
  ],
  "description" : "Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "fhirVersion" : "5.0.0",
  "mapping" : [
    {
      "identity" : "w5",
      "uri" : "http://hl7.org/fhir/fivews",
      "name" : "FiveWs Pattern Mapping"
    },
    {
      "identity" : "idmp-substance",
      "uri" : "https://www.iso.org/obp/ui/#iso:std:iso:11238",
      "name" : "IDMP Mapping (Substance)"
    },
    {
      "identity" : "rim",
      "uri" : "http://hl7.org/v3",
      "name" : "RIM Mapping"
    }
  ],
  "kind" : "resource",
  "abstract" : false,
  "type" : "SubstanceDefinition",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
  "derivation" : "constraint",
  "snapshot" : {
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "short" : "The detailed description of a substance, typically at a level beyond what is used for prescribing",
        "definition" : "The detailed description of a substance, typically at a level beyond what is used for prescribing.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition",
          "min" : 0,
          "max" : "*"
        },
        "constraint" : [
          {
            "key" : "dom-2",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
            "expression" : "contained.contained.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-3",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
            "expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-4",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
            "expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "dom-5",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
            "expression" : "contained.meta.security.empty()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
                "valueBoolean" : true
              },
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
                "valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
              }
            ],
            "key" : "dom-6",
            "severity" : "warning",
            "human" : "A resource should have narrative for robust management",
            "expression" : "text.`div`.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
          },
          {
            "key" : "cmc-when-unii-required",
            "severity" : "error",
            "human" : "A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'",
            "expression" : "(classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803') ).exists()\nimplies code.where(\n  code.coding.system = 'http://fdasis.nlm.nih.gov'\n).exists())\n and classification.coding.where(\n  system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n  code = 'C17021'\n).exists() implies code.where(\n  code.coding.system = 'https://www.uniprot.org'\n).exists()",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-name-isbt",
            "severity" : "error",
            "human" : "Name.type ISBT 128 required for blood products.",
            "expression" : "classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy')",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-source-material",
            "severity" : "error",
            "human" : "IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.",
            "expression" : "sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()\nimplies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Entity, Role, or Act"
          },
          {
            "identity" : "w5",
            "map" : "administrative.medication"
          },
          {
            "identity" : "idmp-substance",
            "map" : "Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.id",
        "path" : "SubstanceDefinition.id",
        "short" : "Logical id of this artifact",
        "definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
        "comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta",
        "path" : "SubstanceDefinition.meta",
        "short" : "Metadata about the resource",
        "definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.meta",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Meta"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.id",
        "path" : "SubstanceDefinition.meta.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.extension",
        "path" : "SubstanceDefinition.meta.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.versionId",
        "path" : "SubstanceDefinition.meta.versionId",
        "short" : "Version specific identifier",
        "definition" : "The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.",
        "comment" : "The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.versionId",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "id"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.lastUpdated",
        "path" : "SubstanceDefinition.meta.lastUpdated",
        "short" : "When the resource version last changed",
        "definition" : "When the resource last changed - e.g. when the version changed.",
        "comment" : "This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a [read](http://hl7.org/fhir/R5/http.html#read) interaction.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.lastUpdated",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "instant"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.source",
        "path" : "SubstanceDefinition.meta.source",
        "short" : "Identifies where the resource comes from",
        "definition" : "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.",
        "comment" : "The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. \n\nThis element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Meta.source",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.profile",
        "path" : "SubstanceDefinition.meta.profile",
        "short" : "Profiles this resource claims to conform to",
        "definition" : "A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url).",
        "comment" : "It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time.  The list of profile URLs is a set.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Meta.profile",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "canonical",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/StructureDefinition"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.meta.security",
        "path" : "SubstanceDefinition.meta.security",
        "short" : "Security Labels applied to this resource",
        "definition" : "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
        "comment" : "The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Meta.security",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SecurityLabels"
            }
          ],
          "strength" : "extensible",
          "description" : "Security Labels from the Healthcare Privacy and Security Classification System.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/security-labels"
        }
      },
      {
        "id" : "SubstanceDefinition.meta.tag",
        "path" : "SubstanceDefinition.meta.tag",
        "short" : "Tags applied to this resource",
        "definition" : "Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.",
        "comment" : "The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Meta.tag",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Tags"
            }
          ],
          "strength" : "example",
          "description" : "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\".",
          "valueSet" : "http://hl7.org/fhir/ValueSet/common-tags"
        }
      },
      {
        "id" : "SubstanceDefinition.implicitRules",
        "path" : "SubstanceDefinition.implicitRules",
        "short" : "A set of rules under which this content was created",
        "definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
        "comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.implicitRules",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : true,
        "isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
        "isSummary" : true
      },
      {
        "id" : "SubstanceDefinition.language",
        "path" : "SubstanceDefinition.language",
        "short" : "Language of the resource content",
        "definition" : "The base language in which the resource is written.",
        "comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.language",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        }
      },
      {
        "id" : "SubstanceDefinition.text",
        "path" : "SubstanceDefinition.text",
        "short" : "Text summary of the resource, for human interpretation",
        "definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
        "comment" : "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
        "alias" : [
          "narrative",
          "html",
          "xhtml",
          "display"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "DomainResource.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Narrative"
          }
        ],
        "condition" : [
          "dom-6"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Act.text?"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.contained",
        "path" : "SubstanceDefinition.contained",
        "short" : "Contained, inline Resources",
        "definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
        "comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
        "alias" : [
          "inline resources",
          " "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Moiety.Amount"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.moiety.measurementType",
        "path" : "SubstanceDefinition.moiety.measurementType",
        "short" : "The measurement type of the quantitative value",
        "definition" : "The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.moiety.measurementType",
          "min" : 0,
          "max" : "1"
        },
   &n }
        ]
      },
      {
        "id" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
        "path" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
        "short" : "Specified per moiety according to the Hill system",
        "definition" : "Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.structure.molecularFormulaByMoiety",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
               "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "short" : "Identity of the terminology system",
        "definition" : "The identification of the code system that defines the meaning of the symbol in the code.",
        "comment" : "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
        "requirements" : "Need to be unambiguous about the source of the definition of the symbol.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Coding.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "patternUri" : "http://fdasis.nlm.nih.gov",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.3"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystem"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.version",
        "path" : "SubstanceDefinition.code.code.coding.version",
        "short" : "Version of the system - if relevant",
        "definition" : "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
        "comment" : "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.version",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.7"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystemVersion"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.code",
        "path" : "SubstanceDefinition.code.code.coding.code",
        "short" : "Symbol in syntax defined by the system",
        "definition" : "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
        "requirements" : "Need to refer to a particular code in the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "cod-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1"
          },
          {
            "identity" : "rim",
            "map" : "./code"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.display",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.code.code.coding.display",
        "short" : "Representation defined by the system",
        "definition" : "A representation of the meaning of the code in the system, following the rules of the system.",
        "requirements" : "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.display",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "cod-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.2 - but note this is not well followed"
          },
          {
            "identity" : "rim",
            "map" : "CV.displayName"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.userSelected",
        "path" : "SubstanceDefinition.code.code.coding.userSelected",
        "short" : "If this coding was chosen directly by the user",
        "definition" : "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
        "comment" : "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
        "requirements" : "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.userSelected",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "Sometimes implied by being first"
          },
          {
            "identity" : "rim",
            "map" : "CD.codingRationale"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.code.code.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.status",
        "path" : "SubstanceDefinition.code.status",
        "short" : "Status of the code assignment, for example 'provisional', 'approved'",
        "definition" : "Status of the code assignment, for example 'provisional', 'approved'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code_System_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.statusDate",
        "path" : "SubstanceDefinition.code.statusDate",
        "short" : "The date at which the code status was changed",
        "definition" : "The date at which the code status was changed as part of the terminology maintenance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.statusDate",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.note",
        "path" : "SubstanceDefinition.code.note",
        "short" : "Any comment can be provided in this field",
        "definition" : "Any comment can be provided in this field, if necessary.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.code.note",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Annotation"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Comment"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:unii.source",
        "path" : "SubstanceDefinition.code.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.code.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "uniProt",
        "short" : "UniProt ID",
        "definition" : "The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Code"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.id",
        "path" : "SubstanceDefinition.code.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.extension",
        "path" : "SubstanceDefinition.code.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.modifierExtension",
        "path" : "SubstanceDefinition.code.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code",
        "path" : "SubstanceDefinition.code.code",
        "short" : "The specific code",
        "definition" : "The specific code.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.id",
        "path" : "SubstanceDefinition.code.code.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.extension",
        "path" : "SubstanceDefinition.code.code.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.id",
        "path" : "SubstanceDefinition.code.code.coding.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.extension",
        "path" : "SubstanceDefinition.code.code.coding.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "short" : "Identity of the terminology system",
        "definition" : "The identification of the code system that defines the meaning of the symbol in the code.",
        "comment" : "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
        "requirements" : "Need to be unambiguous about the source of the definition of the symbol.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Coding.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "patternUri" : "https://www.uniprot.org",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.3"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystem"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.version",
        "path" : "SubstanceDefinition.code.code.coding.version",
        "short" : "Version of the system - if relevant",
        "definition" : "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
        "comment" : "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.version",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.7"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystemVersion"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.code",
        "path" : "SubstanceDefinition.code.code.coding.code",
        "short" : "Symbol in syntax defined by the system",
        "definition" : "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
        "requirements" : "Need to refer to a particular code in the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "condition" : [
          "cod-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1"
          },
          {
            "identity" : "rim",
            "map" : "./code"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.display",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.code.code.coding.display",
        "short" : "Representation defined by the system",
        "definition" : "A representation of the meaning of the code in the system, following the rules of the system.",
        "requirements" : "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.display",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "cod-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.2 - but note this is not well followed"
          },
          {
            "identity" : "rim",
            "map" : "CV.displayName"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.userSelected",
        "path" : "SubstanceDefinition.code.code.coding.userSelected",
        "short" : "If this coding was chosen directly by the user",
        "definition" : "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
        "comment" : "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
        "requirements" : "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.userSelected",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "Sometimes implied by being first"
          },
          {
            "identity" : "rim",
            "map" : "CD.codingRationale"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.code.code.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.status",
        "path" : "SubstanceDefinition.code.status",
        "short" : "Status of the code assignment, for example 'provisional', 'approved'",
        "definition" : "Status of the code assignment, for example 'provisional', 'approved'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code_System_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.statusDate",
        "path" : "SubstanceDefinition.code.statusDate",
        "short" : "The date at which the code status was changed",
        "definition" : "The date at which the code status was changed as part of the terminology maintenance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.code.statusDate",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Code_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.note",
        "path" : "SubstanceDefinition.code.note",
        "short" : "Any comment can be provided in this field",
        "definition" : "Any comment can be provided in this field, if necessary.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.code.note",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Annotation"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Comment"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.source",
        "path" : "SubstanceDefinition.code.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.code.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Code.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name",
        "path" : "SubstanceDefinition.name",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.coding"
            }
          ],
          "description" : "Slice based on value pattern",
          "rules" : "closed"
        },
        "short" : "Substance Name",
        "definition" : "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
        "min" : 1,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "cmc-name-preferred",
            "severity" : "error",
            "human" : "Name.preferred: at most one = true",
            "expression" : "select(preferred = true).count() < 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "The actual name",
        "definition" : "The actual name.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "sub",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Generic Name",
        "definition" : "A non-branded nor registered name that meant for common use.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C97054",
          "display" : "Generic Name"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:sub.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203355",
          "display" : "GSRS Preferred Term"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "short" : "Names applicable to this substance",
        "definition" : "Names applicable to this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.id",
        "path" : "SubstanceDefinition.name.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.extension",
        "path" : "SubstanceDefinition.name.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.modifierExtension",
        "path" : "SubstanceDefinition.name.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.name",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "short" : "Name type e.g. 'systematic',  'scientific, 'brand'",
        "definition" : "Name type, for example 'systematic',  'scientific, 'brand'.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameType"
            }
          ],
          "strength" : "example",
          "description" : "The type of a name given to a substance.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.id",
        "path" : "SubstanceDefinition.name.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.extension",
        "path" : "SubstanceDefinition.name.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C95517",
          "display" : "ISBT-128 DIN"
        },
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.name.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.status",
        "path" : "SubstanceDefinition.name.status",
        "short" : "The status of the name e.g. 'current', 'proposed'",
        "definition" : "The status of the name, for example 'current', 'proposed'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "If this is the preferred name for this substance",
        "definition" : "If this is the preferred name for this substance.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.preferred",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.language",
        "path" : "SubstanceDefinition.name.language",
        "short" : "Human language that the name is written in",
        "definition" : "Human language that the name is written in.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.language",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            }
          ],
          "strength" : "required",
          "description" : "IETF language tag for a human language",
          "valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
          "additional" : [
            {
              "purpose" : "starter",
              "valueSet" : "http://hl7.org/fhir/ValueSet/languages"
            }
          ]
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Language"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.domain",
        "path" : "SubstanceDefinition.name.domain",
        "short" : "The use context of this name e.g. as an active ingredient or as a food colour additive",
        "definition" : "The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.domain",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameDomain"
            }
          ],
          "strength" : "example",
          "description" : "The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-domain"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Substance_Name_Domain"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.jurisdiction",
        "path" : "SubstanceDefinition.name.jurisdiction",
        "short" : "The jurisdiction where this name applies",
        "definition" : "The jurisdiction where this name applies.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.jurisdiction",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Jurisdiction"
            }
          ],
          "strength" : "example",
          "description" : "Jurisdiction codes",
          "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Jurisdiction"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.synonym",
        "path" : "SubstanceDefinition.name.synonym",
        "short" : "A synonym of this particular name, by which the substance is also known",
        "definition" : "A synonym of this particular name, by which the substance is also known.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.synonym",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.translation",
        "path" : "SubstanceDefinition.name.translation",
        "short" : "A translation for this name into another human language",
        "definition" : "A translation for this name into another human language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.translation",
          "min" : 0,
          "max" : "*"
        },
        "contentReference" : "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official",
        "path" : "SubstanceDefinition.name.official",
        "short" : "Details of the official nature of this name",
        "definition" : "Details of the official nature of this name.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.official",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Official_Name"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.id",
        "path" : "SubstanceDefinition.name.official.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.extension",
        "path" : "SubstanceDefinition.name.official.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.modifierExtension",
        "path" : "SubstanceDefinition.name.official.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.authority",
        "path" : "SubstanceDefinition.name.official.authority",
        "short" : "Which authority uses this official name",
        "definition" : "Which authority uses this official name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.authority",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceNameAuthority"
            }
          ],
          "strength" : "preferred",
          "description" : "An authority that officates substance names.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-name-authority"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.status",
        "path" : "SubstanceDefinition.name.official.status",
        "short" : "The status of the official name, for example 'draft', 'active'",
        "definition" : "The status of the official name, for example 'draft', 'active', 'retired'.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "PublicationStatus"
            }
          ],
          "strength" : "preferred",
          "description" : "The lifecycle status of an artifact.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.official.date",
        "path" : "SubstanceDefinition.name.official.date",
        "short" : "Date of official name change",
        "definition" : "Date of the official name change.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.name.official.date",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Official_Name.Official_Name_Status_Change_Date"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.name:isbt.source",
        "path" : "SubstanceDefinition.name.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.name.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Name.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship",
        "path" : "SubstanceDefinition.relationship",
        "short" : "A link between this substance and another",
        "definition" : "A link between this substance and another, with details of the relationship.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Reference_Information.Relationship"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.id",
        "path" : "SubstanceDefinition.relationship.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.extension",
        "path" : "SubstanceDefinition.relationship.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.modifierExtension",
        "path" : "SubstanceDefinition.relationship.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
        "short" : "A pointer to another substance, as a resource or a representational code",
        "definition" : "A pointer to another substance, as a resource or just a representational code.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.substanceDefinition[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"
            ]
          },
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Related_Substance_Id"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.type",
        "path" : "SubstanceDefinition.relationship.type",
        "short" : "For example \"salt to parent\", \"active moiety\"",
        "definition" : "For example \"salt to parent\", \"active moiety\", \"starting material\", \"polymorph\", \"impurity of\".",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.type",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceRelationshipType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-relationship-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Relationship_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.isDefining",
        "path" : "SubstanceDefinition.relationship.isDefining",
        "short" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships",
        "definition" : "For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.isDefining",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made",
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Is_Defining"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.amount[x]",
        "path" : "SubstanceDefinition.relationship.amount[x]",
        "short" : "A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other",
        "definition" : "A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.amount[x]",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Quantity"
          },
          {
            "code" : "Ratio"
          },
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
        "short" : "For use when the numeric has an uncertain range",
        "definition" : "For use when the numeric has an uncertain range.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.ratioHighLimitAmount",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Ratio"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount.Quantity.High_Limit"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.comparator",
        "path" : "SubstanceDefinition.relationship.comparator",
        "short" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\"",
        "definition" : "An operator for the amount, for example \"average\", \"approximately\", \"less than\".",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.relationship.comparator",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SubstanceAmountType"
            }
          ],
          "strength" : "example",
          "description" : "The relationship between two substance types.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-amount-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Amount_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.relationship.source",
        "path" : "SubstanceDefinition.relationship.source",
        "short" : "Supporting literature",
        "definition" : "Supporting literature.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "SubstanceDefinition.relationship.source",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance_Relationship.Reference_Source"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.nucleicAcid",
        "path" : "SubstanceDefinition.nucleicAcid",
        "short" : "Data items specific to nucleic acids",
        "definition" : "Data items specific to nucleic acids.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.nucleicAcid",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceNucleicAcid"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to add specifics of Nucleic Acids to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.polymer",
        "path" : "SubstanceDefinition.polymer",
        "short" : "Data items specific to polymers",
        "definition" : "Data items specific to polymers.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.polymer",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstancePolymer"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Polymers to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.protein",
        "path" : "SubstanceDefinition.protein",
        "short" : "Data items specific to proteins",
        "definition" : "Data items specific to proteins.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.protein",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/SubstanceProtein"
            ]
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "(used to  add specifics of Proteins to Substances)"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial",
        "path" : "SubstanceDefinition.sourceMaterial",
        "short" : "Material or taxonomic/anatomical source",
        "definition" : "Material or taxonomic/anatomical source for the substance.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Substance.Source_Material"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.id",
        "path" : "SubstanceDefinition.sourceMaterial.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "string"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.extension",
        "path" : "SubstanceDefinition.sourceMaterial.extension",
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "path" : "SubstanceDefinition.sourceMaterial.modifierExtension",
        "short" : "Extensions that cannot be ignored even if unrecognized",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type",
        "path" : "SubstanceDefinition.sourceMaterial.type",
        "short" : "Source Type",
        "definition" : "A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type ",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport" : false,
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "SourceMaterialType"
            }
          ],
          "strength" : "example",
          "description" : "A classification that provides the origin of the substance raw material.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/substance-source-material-type"
        },
        "mapping" : [
          {
            "identity" : "idmp-substance",
            "map" : "Source_Material.Source_Material_Type"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type.id",
        "path" : "SubstanceDefinition.sourceMaterial.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl" : "id"
              }
            ],
            "code" : "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type.extension",
        "path" : "SubstanceDefinition.sourceMaterial.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type.coding",
        "path" : "SubstanceDefinition.sourceMaterial.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"
        },
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "SubstanceDefinition.sourceMaterial.type.text",
        "short" : "Plain text representation of the concept",
        "definition" : "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "requirements" : "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus",
        "path" : "SubstanceDefinition.sourceMaterial.genus",
        "short" : "The genus of an organism e.g. the Latin epithet of the plant/animal scientific name",
        "definition" : "The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "SubstanceDefinition.sourceMaterial.genus",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "source" : "http://hl7.org/fhir/tity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "SubstanceDefinition",
        "path" : "SubstanceDefinition",
        "constraint" : [
          {
            "key" : "cmc-when-unii-required",
            "severity" : "error",
            "human" : "A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'",
            "expression" : "(classification.coding.where(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code in ('C48807' | 'C45305' | 'C706' | 'C48803') ).exists()\nimplies code.where(\n  code.coding.system = 'http://fdasis.nlm.nih.gov'\n).exists())\n and classification.coding.where(\n  system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and\n  code = 'C17021'\n).exists() implies code.where(\n  code.coding.system = 'https://www.uniprot.org'\n).exists()",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-name-isbt",
            "severity" : "error",
            "human" : "Name.type ISBT 128 required for blood products.",
            "expression" : "classification.where(coding.where(code = '8' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy')",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          },
          {
            "key" : "cmc-source-material",
            "severity" : "error",
            "human" : "IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable.",
            "expression" : "sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code in ('C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()\nimplies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ]
      },
      {
        "id" : "SubstanceDefinition.meta.profile",
        "path" : "SubstanceDefinition.meta.profile",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.identifier",
        "path" : "SubstanceDefinition.identifier",
        "short" : "optional user designated identifier",
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.classification",
        "path" : "SubstanceDefinition.classification",
        "short" : "Substance Type",
        "definition" : "A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.\n[Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]",
        "min" : 1,
        "mustSupport" : true,
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"
        }
      },
      {
        "id" : "SubstanceDefinition.grade",
        "path" : "SubstanceDefinition.grade",
        "short" : "Quality Standard",
        "definition" : "The established benchmark to which the component complies. [Source: SME Defined]\nExamples: USP/NF, EP, Company Standard",
        "min" : 1,
        "max" : "1",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"
        }
      },
      {
        "id" : "SubstanceDefinition.manufacturer",
        "path" : "SubstanceDefinition.manufacturer",
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.supplier",
        "path" : "SubstanceDefinition.supplier",
        "max" : "1",
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
            ]
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code",
        "path" : "SubstanceDefinition.code",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "code.coding.system"
            }
          ],
          "rules" : "open"
        },
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "unii",
        "short" : "UNII",
        "definition" : "The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substanceâ€™s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]\nExample: 362O9ITL9D\nNote: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.code:unii.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:unii.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "http://fdasis.nlm.nih.gov",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt",
        "path" : "SubstanceDefinition.code",
        "sliceName" : "uniProt",
        "short" : "UniProt ID",
        "definition" : "The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.\nIt is accessible at https://www.uniprot.org/",
        "min" : 0,
        "max" : "1"
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code",
        "path" : "SubstanceDefinition.code.code",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding",
        "path" : "SubstanceDefinition.code.code.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.code:uniProt.code.coding.system",
        "path" : "SubstanceDefinition.code.code.coding.system",
        "min" : 1,
        "patternUri" : "https://www.uniprot.org",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name",
        "path" : "SubstanceDefinition.name",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "type.coding"
            }
          ],
          "description" : "Slice based on value pattern",
          "rules" : "closed"
        },
        "short" : "Substance Name",
        "definition" : "Substance Name is identified by its Substance Type.\nSubstance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]\nExamples: GSRS Preferred Term, Systematic Name, INN, USP/NF",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-name-preferred",
            "severity" : "error",
            "human" : "Name.preferred: at most one = true",
            "expression" : "select(preferred = true).count() < 2",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "short" : "True when the name type is Substance Name",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "sub",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "Generic Name",
        "definition" : "A non-branded nor registered name that meant for common use.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C97054",
          "display" : "Generic Name"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:sub.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "gsrs",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "GSRS Preferred Term",
        "definition" : "Default display name identified within FDA Global Substance Registration System (GSRS).",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C203355",
          "display" : "GSRS Preferred Term"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:gsrs.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt",
        "path" : "SubstanceDefinition.name",
        "sliceName" : "isbt",
        "min" : 0,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.name",
        "path" : "SubstanceDefinition.name.name",
        "short" : "ISBT-128 DIN",
        "definition" : "It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type",
        "path" : "SubstanceDefinition.name.type",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.type.coding",
        "path" : "SubstanceDefinition.name.type.coding",
        "min" : 1,
        "max" : "1",
        "patternCoding" : {
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "code" : "C95517",
          "display" : "ISBT-128 DIN"
        },
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.name:isbt.preferred",
        "path" : "SubstanceDefinition.name.preferred",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial",
        "path" : "SubstanceDefinition.sourceMaterial",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type",
        "path" : "SubstanceDefinition.sourceMaterial.type",
        "short" : "Source Type",
        "definition" : "A classification that provides the origin of the raw material. [Source: SME Defined]\nExample: cat hair would be an Animal source type ",
        "min" : 1
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.type.coding",
        "path" : "SubstanceDefinition.sourceMaterial.type.coding",
        "binding" : {
          "strength" : "required",
          "valueSet" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"
        }
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus",
        "path" : "SubstanceDefinition.sourceMaterial.genus",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus.coding",
        "path" : "SubstanceDefinition.sourceMaterial.genus.coding",
        "max" : "0"
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.genus.text",
        "path" : "SubstanceDefinition.sourceMaterial.genus.text",
        "short" : "Source Organism",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "min" : 1
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species",
        "path" : "SubstanceDefinition.sourceMaterial.species",
        "short" : "Source Organism",
        "definition" : "The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]\nExamples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species.coding",
        "path" : "SubstanceDefinition.sourceMaterial.species.coding",
        "max" : "0"
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.species.text",
        "path" : "SubstanceDefinition.sourceMaterial.species.text",
        "min" : 1
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.part",
        "path" : "SubstanceDefinition.sourceMaterial.part",
        "short" : "Source Organism Part",
        "definition" : "A fragment of the source organism. [Source: SME Defined]\nExamples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.\nIDMP 11238 definition & examples: Entity of anatomical origin of source material within an organism.\nCartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal ",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.part.text",
        "path" : "SubstanceDefinition.sourceMaterial.part.text",
        "min" : 1,
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin",
        "short" : "Source Organism Country of Origin",
        "definition" : "The name of the country where the organism was reared. [Source: SME Defined]",
        "max" : "1",
        "constraint" : [
          {
            "key" : "cmc-iso-genc-overlap",
            "severity" : "error",
            "human" : "Only country codes that are also member of GENC can be used.",
            "expression" : "coding.where(\n    (system = 'urn:iso:std:iso:3166') and (\n    code in ('ALA'|'PSE'|'SJM'|'UMI')\n    )\n).exists().not()",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin.coding",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code",
        "path" : "SubstanceDefinition.sourceMaterial.countryOfOrigin.coding.code",
        "min" : 1,
        "constraint" : [
          {
            "key" : "cmc-only-ISO-3166-1-alpha-3",
            "severity" : "error",
            "human" : "Country must be a 3 letter country code",
            "expression" : "$this.length() = 3",
            "source" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
          }
        ],
        "mustSupport" : true
      }
    ]
  }
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.