| Package | hl7.eu.fhir.unicom |
| Type | StructureDefinition |
| Id | Id |
| FHIR Version | R5 |
| Source | http://unicom-project.eu/fhir/https://build.fhir.org/ig/hl7-eu/unicom-ig/StructureDefinition-PPLPackagedProductDefinition.html |
| Url | http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition |
| Version | 0.1.0 |
| Status | draft |
| Date | 2024-10-11T11:07:46+00:00 |
| Name | PPLPackagedProductDefinition |
| Title | PPL Packaged Product profile |
| Experimental | False |
| Realm | eu |
| Authority | hl7 |
| Description | Packaged Product |
| Type | PackagedProductDefinition |
| Kind | resource |
| StructureDefinition | |
PPLPackagedProductDefinition  | PPL Packaged Product profile |
| PPLRegulatedAuthorization | PPL Marketing Authorisation profile |
| StructureDefinition | |
| PPLManufacturedItemDefinition | PPL Manufactured Item profile |
| PPLMedicinalProductDefinition | PPL Medicinal Product profile |
| PPLPackagedProductDefinition | PPL Packaged Product profile |
| http://unicom-project.eu/fhir/ValueSet/all-units-vs | EMA SPOR All Units Combined |
| http://unicom-project.eu/fhir/ValueSet/country-ema-vs | EMA SPOR Country |
| http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs | EMA SPOR Legal Status for the Supply |
| http://unicom-project.eu/fhir/ValueSet/material-vs | EMA SPOR Material |
| http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs | EMA SPOR Unit of Presentation |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition PPLPackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
  Slices for identifier | 1..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system | |
   identifier:pcid | 1..1 | Identifier | PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different. | |
   system | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid | |
 packageFor | 1..* | Reference(PPL Medicinal Product profile) | The product that this is a pack for | |
| containedItemQuantity | 1..* | Quantity | Pack size. Repeated for combination packages. | |
 code | 0..1 | code | Coded form of the unit Binding: EMA SPOR Unit of Presentation (required) | |
| description | 1..1 | markdown | Textual description. Note that this is not the name of the package or product | |
| legalStatusOfSupply | 0..1 | BackboneElement | Legal status of supply on the packaged product level. | |
| code | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: EMA SPOR Legal Status for the Supply (required) | |
| jurisdiction | ||||
| coding | 0..* | Coding | Code defined by a terminology system Binding: EMA SPOR Country (required) | |
| marketingStatus | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | |
| country | 1..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements | |
| coding | 0..* | Coding | Code defined by a terminology system Binding: EMA SPOR Country (required) | |
| status | ||||
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052 | |
| packaging | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | |
| type | 1..1 | CodeableConcept | Container type | |
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346 | |
| quantity | 1..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | |
| material | 0..* | CodeableConcept | Material type of the package item Binding: EMA SPOR Material (required) | |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
| type | 1..1 | CodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified | |
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343 | |
| period[x] | 1..1 | Duration, string | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used | |
| containedItem | 0..* | BackboneElement | An item (inner package or manufactured item) within the packaging | |
| item | 1..1 | CodeableReference(PPL Packaged Product profile | PPL Manufactured Item profile) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | |
| amount | 0..1 | Quantity | Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition | |
| code | 0..1 | code | Coded form of the unit Binding: EMA SPOR All Units Combined (required) | |
| Documentation for this format | ||||
FHIR{
"resourceType" : "StructureDefinition",
"id" : "PPLPackagedProductDefinition",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition PPLPackagedProductDefinition</b></p><a name=\"PPLPackagedProductDefinition\"> </a><a name=\"hcPPLPackagedProductDefinition\"> </a><a name=\"PPLPackagedProductDefinition-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 & 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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition\">PackagedProductDefinition</a><a name=\"PackagedProductDefinition\"> </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 href=\"http://hl7.org/fhir/R5/packagedproductdefinition.html\">PackagedProductDefinition</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\">A medically related item or items, in a container or package</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.identifier\" title=\"Identifier for the packaged product: PCID, national code or other.\">Slices for identifier</a><a name=\"PackagedProductDefinition.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=\"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/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\"><span style=\"font-style: italic\">Identifier for the packaged product: PCID, national ID, or other</span><br style=\"font-style: italic\"/><span style=\"font-weight:bold; font-style: italic\">Slice: </span><span style=\"font-style: italic\">Unordered, Open by pattern: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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.identifier:pcid\" title=\"Slice pcid: EMA IG 4.1\">identifier:pcid</a><a name=\"PackagedProductDefinition.identifier.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\">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#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.identifier:pcid.system\">system</a><a name=\"PackagedProductDefinition.identifier.system\"> </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#uri\">uri</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 namespace for the identifier value</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">http://ema.europa.eu/example/pcid</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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packageFor\">packageFor</a><a name=\"PackagedProductDefinition.packageFor\"> </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\">*</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-PPLMedicinalProductDefinition.html\">PPL Medicinal Product 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=\"opacity: 0.5\">The product that this is a pack for</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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.containedItemQuantity\" title=\"EMA IG 4.4\">containedItemQuantity</a><a name=\"PackagedProductDefinition.containedItemQuantity\"> </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\">*</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#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Pack size. Repeated for combination packages.</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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.containedItemQuantity.code\">code</a><a name=\"PackagedProductDefinition.containedItemQuantity.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\"/><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#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=\"opacity: 0.5\">Coded form of the unit</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-unit-of-presentation-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs\">EMA SPOR Unit of Presentation</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.description\" title=\"EMA IG 4.2\">description</a><a name=\"PackagedProductDefinition.description\"> </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#markdown\">markdown</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\">Textual description. Note that this is not the name of the package or product</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_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: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.legalStatusOfSupply\" title=\"EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level\">legalStatusOfSupply</a><a name=\"PackagedProductDefinition.legalStatusOfSupply\"> </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>..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\">Legal status of supply on the packaged product level.</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_bck110.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.legalStatusOfSupply.code\">code</a><a name=\"PackagedProductDefinition.legalStatusOfSupply.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\"><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 actual status of supply. In what situation this package type may be supplied for use</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-legal-status-for-the-supply-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs\">EMA SPOR Legal Status for the Supply</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_bck101.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.legalStatusOfSupply.jurisdiction\">jurisdiction</a><a name=\"PackagedProductDefinition.legalStatusOfSupply.jurisdiction\"> </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\"/></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_bck1000.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding\">coding</a><a name=\"PackagedProductDefinition.legalStatusOfSupply.jurisdiction.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=\"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: #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\">Binding: </span><a href=\"ValueSet-country-ema-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/country-ema-vs\">EMA SPOR Country</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_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: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus\" title=\"EMA IG 4.6\">marketingStatus</a><a name=\"PackagedProductDefinition.marketingStatus\"> </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/marketingstatus.html#MarketingStatus\">MarketingStatus</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\">Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated</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_bck111.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus.country\">country</a><a name=\"PackagedProductDefinition.marketingStatus.country\"> </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\"><span style=\"opacity: 0.5\">The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements</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_bck1100.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus.country.coding\">coding</a><a name=\"PackagedProductDefinition.marketingStatus.country.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-country-ema-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/country-ema-vs\">EMA SPOR Country</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_bck101.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: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus.status\">status</a><a name=\"PackagedProductDefinition.marketingStatus.status\"> </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_bck1001.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus.status.coding\">coding</a><a name=\"PackagedProductDefinition.marketingStatus.status.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\"/><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_bck10000.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.marketingStatus.status.coding.system\">system</a><a name=\"PackagedProductDefinition.marketingStatus.status.coding.system\"> </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><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#uri\">uri</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\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">https://spor.ema.europa.eu/v1/lists/100000072052</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging\">packaging</a><a name=\"PackagedProductDefinition.packaging\"> </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/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\">A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.type\" title=\"EMA IG 4.8.1\">type</a><a name=\"PackagedProductDefinition.packaging.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\">Container 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_bck0101.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.type.coding\">coding</a><a name=\"PackagedProductDefinition.packaging.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\"/><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_bck01000.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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.type.coding.system\">system</a><a name=\"PackagedProductDefinition.packaging.type.coding.system\"> </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><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#uri\">uri</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\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">https://spor.ema.europa.eu/v1/lists/100000073346</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_bck010.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.quantity\" title=\"EMA IG 4.8.5\">quantity</a><a name=\"PackagedProductDefinition.packaging.quantity\"> </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#integer\">integer</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 quantity of this level of packaging in the package that contains it (with the outermost level being 1)</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_bck010.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.material\" title=\"EMA IG 4.8.7\">material</a><a name=\"PackagedProductDefinition.packaging.material\"> </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><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</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\">Material type of the package item</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-material-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/material-vs\">EMA SPOR Material</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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.shelfLifeStorage\" title=\"EMA IG 4.12\">shelfLifeStorage</a><a name=\"PackagedProductDefinition.packaging.shelfLifeStorage\"> </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/productshelflife.html#ProductShelfLife\">ProductShelfLife</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\">Shelf Life and storage information</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_bck0111.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\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.shelfLifeStorage.type\">type</a><a name=\"PackagedProductDefinition.packaging.shelfLifeStorage.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\"><span style=\"opacity: 0.5\">This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified</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_bck01101.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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.shelfLifeStorage.type.coding\">coding</a><a name=\"PackagedProductDefinition.packaging.shelfLifeStorage.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\"/><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_bck011000.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_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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.shelfLifeStorage.type.coding.system\">system</a><a name=\"PackagedProductDefinition.packaging.shelfLifeStorage.type.coding.system\"> </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><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#uri\">uri</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\">Identity of the terminology system</span><br/><span style=\"font-weight:bold\">Required Pattern: </span><span style=\"color: darkgreen\">https://spor.ema.europa.eu/v1/lists/100000073343</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_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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.shelfLifeStorage.period[x]\">period[x]</a><a name=\"PackagedProductDefinition.packaging.shelfLifeStorage.period_x_\"> </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#Duration\">Duration</a><span style=\"opacity: 0.5\">, </span><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\">The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used</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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.containedItem\" title=\"EMA IG 4.9 or 4.8.3\">containedItem</a><a name=\"PackagedProductDefinition.packaging.containedItem\"> </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><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</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/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\">An item (inner package or manufactured item) within the packaging</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_bck0010.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.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-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.containedItem.item\">item</a><a name=\"PackagedProductDefinition.packaging.containedItem.item\"> </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\">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: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R5/references.html\">CodeableReference</a>(<a href=\"StructureDefinition-PPLPackagedProductDefinition.html\">PPL Packaged Product profile</a> | <a href=\"StructureDefinition-PPLManufacturedItemDefinition.html\">PPL Manufactured Item 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=\"opacity: 0.5\">The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package</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_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: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.containedItem.amount\" title=\"EMA IG 4.11.2\">amount</a><a name=\"PackagedProductDefinition.packaging.containedItem.amount\"> </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><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#Quantity\">Quantity</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition</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_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: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-PPLPackagedProductDefinition-definitions.html#PackagedProductDefinition.packaging.containedItem.amount.code\">code</a><a name=\"PackagedProductDefinition.packaging.containedItem.amount.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\"/><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#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=\"opacity: 0.5\">Coded form of the unit</span><br/><span style=\"font-weight:bold\">Binding: </span><a href=\"ValueSet-all-units-vs.html\" title=\"http://unicom-project.eu/fhir/ValueSet/all-units-vs\">EMA SPOR All Units Combined</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><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>"
},
"url" : "http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition",
"version" : "0.1.0",
"name" : "PPLPackagedProductDefinition",
"title" : "PPL Packaged Product profile",
"status" : "draft",
"date" : "2024-10-11T11:07:46+00:00",
"publisher" : "UNICOM",
"contact" : [
{
"name" : "UNICOM",
"telecom" : [
{
"system" : "url",
"value" : "http://unicom-project.eu"
}
]
}
],
"description" : "Packaged Product",
"fhirVersion" : "5.0.0",
"mapping" : [
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "idmp",
"uri" : "https://www.iso.org/obp/ui/#iso:std:iso:11615",
"name" : "IDMP Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "PackagedProductDefinition",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
"derivation" : "constraint",
"snapshot" : {
"element" : [
{
"id" : "PackagedProductDefinition",
"path" : "PackagedProductDefinition",
"short" : "A medically related item or items, in a container or package",
"definition" : "A medically related item or items, in a container or package.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition",
"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"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Entity, Role, or Act"
},
{
"identity" : "w5",
"map" : "administrative.medication"
},
{
"identity" : "idmp",
"map" : "Packaged Medicinal Product"
}
]
},
{
"id" : "PackagedProductDefinition.id",
"path" : "PackagedProductDefinition.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" : "PackagedProductDefinition.meta",
"path" : "PackagedProductDefinition.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" : "PackagedProductDefinition.implicitRules",
"path" : "PackagedProductDefinition.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" : "PackagedProductDefinition.language",
"path" : "PackagedProductDefinition.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" : "PackagedProductDefinition.text",
"path" : "PackagedProductDefinition.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" : "PackagedProductDefinition.contained",
"path" : "PackagedProductDefinition.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",
"anonymous resources",
"contained resources"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Resource"
}
],
"condition" : [
"dom-2",
"dom-4",
"dom-3",
"dom-5"
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PackagedProductDefinition.extension",
"path" : "PackagedProductDefinition.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 resource. 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" : "DomainResource.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"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PackagedProductDefinition.modifierExtension",
"path" : "PackagedProductDefinition.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to 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"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.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"
}
],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "PackagedProductDefinition.identifier",
"path" : "PackagedProductDefinition.identifier",
"slicing" : {
"discriminator" : [
{
"type" : "pattern",
"path" : "system"
}
],
"rules" : "open"
},
"short" : "Identifier for the packaged product: PCID, national ID, or other",
"definition" : "Identifier for the packaged product: PCID, national code or other.",
"min" : 1,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"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" : "w5",
"map" : "FiveWs.class"
},
{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.PCID"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid",
"path" : "PackagedProductDefinition.identifier",
"sliceName" : "pcid",
"short" : "PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.",
"definition" : "EMA IG 4.1",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"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" : "w5",
"map" : "FiveWs.class"
},
{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.PCID"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.id",
"path" : "PackagedProductDefinition.identifier.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" : "PackagedProductDefinition.identifier:pcid.extension",
"path" : "PackagedProductDefinition.identifier.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" : "PackagedProductDefinition.identifier:pcid.use",
"path" : "PackagedProductDefinition.identifier.use",
"short" : "usual | official | temp | secondary | old (If known)",
"definition" : "The purpose of this identifier.",
"comment" : "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"requirements" : "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.use",
"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"
}
],
"isModifier" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierUse"
}
],
"strength" : "required",
"description" : "Identifies the purpose for this identifier, if known .",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"
},
"mapping" : [
{
"identity" : "v2",
"map" : "N/A"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.type",
"path" : "PackagedProductDefinition.identifier.type",
"short" : "Description of identifier",
"definition" : "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"comment" : "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
"requirements" : "Allows users to make use of identifiers when the identifier system is not known.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.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"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierType"
}
],
"strength" : "extensible",
"description" : "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-type"
},
"mapping" : [
{
"identity" : "v2",
"map" : "CX.5"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.system",
"path" : "PackagedProductDefinition.identifier.system",
"short" : "The namespace for the identifier value",
"definition" : "Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.",
"comment" : "Identifier.system is always case sensitive.",
"requirements" : "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Identifier.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"patternUri" : "http://ema.europa.eu/example/pcid",
"example" : [
{
"label" : "General",
"valueUri" : "http://www.acme.com/identifiers/patient"
}
],
"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" : "CX.4 / EI-2-4"
},
{
"identity" : "rim",
"map" : "II.root or Role.id.root"
},
{
"identity" : "servd",
"map" : "./IdentifierType"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.value",
"path" : "PackagedProductDefinition.identifier.value",
"short" : "The value that is unique",
"definition" : "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"comment" : "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"example" : [
{
"label" : "General",
"valueString" : "123456"
}
],
"condition" : [
"ident-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" : "CX.1 / EI.1"
},
{
"identity" : "rim",
"map" : "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"
},
{
"identity" : "servd",
"map" : "./Value"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.period",
"path" : "PackagedProductDefinition.identifier.period",
"short" : "Time period when id is/was valid for use",
"definition" : "Time period during which identifier is/was valid for use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.period",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"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" : "CX.7 + CX.8"
},
{
"identity" : "rim",
"map" : "Role.effectiveTime or implied by context"
},
{
"identity" : "servd",
"map" : "./StartDate and ./EndDate"
}
]
},
{
"id" : "PackagedProductDefinition.identifier:pcid.assigner",
"path" : "PackagedProductDefinition.identifier.assigner",
"short" : "Organization that issued id (may be just text)",
"definition" : "Organization that issued/manages the identifier.",
"comment" : "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.assigner",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"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" : "CX.4 / (CX.4,CX.9,CX.10)"
},
{
"identity" : "rim",
"map" : "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"
},
{
"identity" : "servd",
"map" : "./IdentifierIssuingAuthority"
}
]
},
{
"id" : "PackagedProductDefinition.name",
"path" : "PackagedProductDefinition.name",
"short" : "A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc",
"definition" : "A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.name",
"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"
}
],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "idmp",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.type",
"path" : "PackagedProductDefinition.type",
"short" : "A high level category e.g. medicinal product, raw material, shipping container etc",
"definition" : "A high level category e.g. medicinal product, raw material, shipping/transport container, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.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" : "PackageType"
}
],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-type"
},
"mapping" : [
{
"identity" : "idmp",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.packageFor",
"path" : "PackagedProductDefinition.packageFor",
"short" : "The product that this is a pack for",
"definition" : "The product this package model relates to, not the contents of the package (for which see package.containedItem).",
"min" : 1,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packageFor",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"
]
}
],
"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",
"map" : "(the link from Packaged Medicinal Product to Medicinal Product)"
}
]
},
{
"id" : "PackagedProductDefinition.status",
"path" : "PackagedProductDefinition.status",
"short" : "The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status",
"definition" : "The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.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" : true,
"isModifierReason" : "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid",
"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",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.statusDate",
"path" : "PackagedProductDefinition.statusDate",
"short" : "The date at which the given status became applicable",
"definition" : "The date at which the given status became applicable.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.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",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity",
"path" : "PackagedProductDefinition.containedItemQuantity",
"short" : "Pack size. Repeated for combination packages.",
"definition" : "EMA IG 4.4",
"min" : 1,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.containedItemQuantity",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Quantity"
}
],
"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",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.id",
"path" : "PackagedProductDefinition.containedItemQuantity.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" : "PackagedProductDefinition.containedItemQuantity.extension",
"path" : "PackagedProductDefinition.containedItemQuantity.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" : "PackagedProductDefinition.containedItemQuantity.value",
"path" : "PackagedProductDefinition.containedItemQuantity.value",
"short" : "Numerical value (with implicit precision)",
"definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
"comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"requirements" : "Precision is handled implicitly in almost all cases of measurement.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "decimal"
}
],
"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" : "SN.2 / CQ - N/A"
},
{
"identity" : "rim",
"map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.comparator",
"path" : "PackagedProductDefinition.containedItemQuantity.comparator",
"short" : "< | <= | >= | > | ad - how to understand the value",
"definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.comparator",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
"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" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "QuantityComparator"
}
],
"strength" : "required",
"description" : "How the Quantity should be understood and represented.",
"valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
},
"mapping" : [
{
"identity" : "v2",
"map" : "SN.1 / CQ.1"
},
{
"identity" : "rim",
"map" : "IVL properties"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.unit",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.containedItemQuantity.unit",
"short" : "Unit representation",
"definition" : "A human-readable form of the unit.",
"requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.unit",
"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" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.unit"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.system",
"path" : "PackagedProductDefinition.containedItemQuantity.system",
"short" : "System that defines coded unit form",
"definition" : "The identification of the system that provides the coded form of the unit.",
"requirements" : "Need to know the system that defines the coded form of the unit.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"condition" : [
"qty-3"
],
"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" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "CO.codeSystem, PQ.translation.codeSystem"
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.code",
"path" : "PackagedProductDefinition.containedItemQuantity.code",
"short" : "Coded form of the unit",
"definition" : "A computer processable form of the unit in some unit representation system.",
"comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"condition" : [
"qty-3"
],
"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://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs"
},
"mapping" : [
{
"identity" : "v2",
"map" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.code, MO.currency, PQ.translation.code"
}
]
},
{
"id" : "PackagedProductDefinition.description",
"path" : "PackagedProductDefinition.description",
"short" : "Textual description. Note that this is not the name of the package or product",
"definition" : "EMA IG 4.2",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"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",
"map" : "Packaged Medicinal Product.description"
}
]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply",
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"short" : "Legal status of supply on the packaged product level.",
"definition" : "EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"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",
"map" : "Marketing Authorization.Legal Status of Supply (for a package)"
}
]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.id",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.extension",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.modifierExtension",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.code",
"path" : "PackagedProductDefinition.legalStatusOfSupply.code",
"short" : "The actual status of supply. In what situation this package type may be supplied for use",
"definition" : "The actual status of supply. Conveys in what situation this package type may be supplied for use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs"
},
"mapping" : [
{
"identity" : "idmp",
"map" : "Marketing Authorization.Legal Status of Supply (for a package)"
}
]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"short" : "The place where the legal status of supply applies",
"definition" : "The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"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" : "Jurisdiction"
}
],
"strength" : "example",
"description" : "Jurisdiction codes",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [
{
"identity" : "idmp",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.id",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.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" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.extension",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.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" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.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://unicom-project.eu/fhir/ValueSet/country-ema-vs"
},
"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" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.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" : "PackagedProductDefinition.marketingStatus",
"path" : "PackagedProductDefinition.marketingStatus",
"short" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
"definition" : "EMA IG 4.6",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.marketingStatus",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "MarketingStatus"
}
],
"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",
"map" : "Packaged Medicinal Product.Marketing Status"
}
]
},
{
"id" : "PackagedProductDefinition.marketingStatus.id",
"path" : "PackagedProductDefinition.marketingStatus.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" : "PackagedProductDefinition.marketingStatus.extension",
"path" : "PackagedProductDefinition.marketingStatus.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" : "PackagedProductDefinition.marketingStatus.modifierExtension",
"path" : "PackagedProductDefinition.marketingStatus.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" : "BackboneType.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" : "PackagedProductDefinition.marketingStatus.country",
"path" : "PackagedProductDefinition.marketingStatus.country",
"short" : "The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements",
"definition" : "The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MarketingStatus.country",
"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"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.marketingStatus.country.id",
"path" : "PackagedProductDefinition.marketingStatus.country.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" : "PackagedProductDefinition.marketingStatus.country.extension",
"path" : "PackagedProductDefinition.marketingStatus.country.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" : "PackagedProductDefinition.marketingStatus.country.coding",
"path" : "PackagedProductDefinition.marketingStatus.country.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://unicom-project.eu/fhir/ValueSet/country-ema-vs"
},
"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" : "PackagedProductDefinition.marketingStatus.country.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.marketingStatus.country.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" : "PackagedProductDefinition.marketingStatus.jurisdiction",
"path" : "PackagedProductDefinition.marketingStatus.jurisdiction",
"short" : "Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified",
"definition" : "Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MarketingStatus.jurisdiction",
"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"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.marketingStatus.status",
"path" : "PackagedProductDefinition.marketingStatus.status",
"short" : "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples",
"definition" : "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MarketingStatus.status",
"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"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.marketingStatus.status.id",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.extension",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding",
"path" : "PackagedProductDefinition.marketingStatus.status.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,
"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" : "PackagedProductDefinition.marketingStatus.status.coding.id",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding.extension",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding.system",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : 0,
"max" : "1",
"base" : {
"path" : "Coding.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"patternUri" : "https://spor.ema.europa.eu/v1/lists/100000072052",
"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.3"
},
{
"identity" : "rim",
"map" : "./codeSystem"
},
{
"identity" : "orim",
"map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
}
]
},
{
"id" : "PackagedProductDefinition.marketingStatus.status.coding.version",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding.code",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding.display",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.coding.userSelected",
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.status.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.marketingStatus.status.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" : "PackagedProductDefinition.marketingStatus.dateRange",
"path" : "PackagedProductDefinition.marketingStatus.dateRange",
"short" : "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market†refers to the release of the Medicinal Product into the distribution chain",
"definition" : "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market†refers to the release of the Medicinal Product into the distribution chain.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MarketingStatus.dateRange",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"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" : "PackagedProductDefinition.marketingStatus.restoreDate",
"path" : "PackagedProductDefinition.marketingStatus.restoreDate",
"short" : "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market†refers to the release of the Medicinal Product into the distribution chain",
"definition" : "The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market†refers to the release of the Medicinal Product into the distribution chain.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MarketingStatus.restoreDate",
"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"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.copackagedIndicator",
"path" : "PackagedProductDefinition.copackagedIndicator",
"short" : "Identifies if the drug product is supplied with another item such as a diluent or adjuvant",
"definition" : "Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.copackagedIndicator",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "boolean"
}
],
"meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is co-packaged 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",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.manufacturer",
"path" : "PackagedProductDefinition.manufacturer",
"short" : "Manufacturer of this package type (multiple means these are all possible manufacturers)",
"definition" : "Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.manufacturer",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"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",
"map" : "Packaged Medicinal Product.Manufacturer / Establishment (Organisation)"
}
]
},
{
"id" : "PackagedProductDefinition.attachedDocument",
"path" : "PackagedProductDefinition.attachedDocument",
"short" : "Additional information or supporting documentation about the packaged product",
"definition" : "Additional information or supporting documentation about the packaged product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.attachedDocument",
"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",
"map" : "n/a"
}
]
},
{
"id" : "PackagedProductDefinition.packaging",
"path" : "PackagedProductDefinition.packaging",
"short" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap",
"definition" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging",
"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" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.id",
"path" : "PackagedProductDefinition.packaging.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" : "PackagedProductDefinition.packaging.extension",
"path" : "PackagedProductDefinition.packaging.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" : "PackagedProductDefinition.packaging.modifierExtension",
"path" : "PackagedProductDefinition.packaging.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" : "PackagedProductDefinition.packaging.identifier",
"path" : "PackagedProductDefinition.packaging.identifier",
"short" : "An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier",
"definition" : "A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packaging.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"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",
"map" : "Package Item (Container).Data Carrier Identifier"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.type",
"path" : "PackagedProductDefinition.packaging.type",
"short" : "Container type",
"definition" : "EMA IG 4.8.1",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging.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" : "PackagingType"
}
],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/packaging-type"
},
"mapping" : [
{
"identity" : "idmp",
"map" : "Package Item (Container).Package Item (Container) Type"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.type.id",
"path" : "PackagedProductDefinition.packaging.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" : "PackagedProductDefinition.packaging.type.extension",
"path" : "PackagedProductDefinition.packaging.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" : "PackagedProductDefinition.packaging.type.coding",
"path" : "PackagedProductDefinition.packaging.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,
"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" : "PackagedProductDefinition.packaging.type.coding.id",
"path" : "PackagedProductDefinition.packaging.type.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" : "PackagedProductDefinition.packaging.type.coding.extension",
"path" : "PackagedProductDefinition.packaging.type.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" : "PackagedProductDefinition.packaging.type.coding.system",
"path" : "PackagedProductDefinition.packaging.type.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" : 0,
"max" : "1",
"base" : {
"path" : "Coding.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"patternUri" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"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.3"
},
{
"identity" : "rim",
"map" : "./codeSystem"
},
{
"identity" : "orim",
"map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.type.coding.version",
"path" : "PackagedProductDefinition.packaging.type.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"
},
&nb "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"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.packaging.manufacturer",
"path" : "PackagedProductDefinition.packaging.manufacturer",
"short" : "Manufacturer of this packaging item (multiple means these are all potential manufacturers)",
"definition" : "Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packaging.manufacturer",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"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",
"map" : "Package Item (Container).Manufacturer / Establishment (Organisation)"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.property",
"path" : "PackagedProductDefinition.packaging.property",
"short" : "General characteristics of this item",
"definition" : "General characteristics of this item.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packaging.property",
"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",
"map" : "Package Item (Container).Physical Characteristics"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.property.id",
"path" : "PackagedProductDefinition.packaging.property.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" : "PackagedProductDefinition.packaging.property.extension",
"path" : "PackagedProductDefinition.packaging.property.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" : "PackagedProductDefinition.packaging.property.modifierExtension",
"path" : "PackagedProductDefinition.packaging.property.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" : "PackagedProductDefinition.packaging.property.type",
"path" : "PackagedProductDefinition.packaging.property.type",
"short" : "A code expressing the type of characteristic",
"definition" : "A code expressing the type of characteristic.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging.property.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" : "ProductCharacteristic"
}
],
"strength" : "example",
"description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
"valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
},
"mapping" : [
{
"identity" : "idmp",
"map" : "Physical Characteristics, all attributes"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.property.value[x]",
"path" : "PackagedProductDefinition.packaging.property.value[x]",
"short" : "A value for the characteristic",
"definition" : "A value for the characteristic.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging.property.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
},
{
"code" : "Quantity"
},
{
"code" : "date"
},
{
"code" : "boolean"
},
{
"code" : "Attachment"
}
],
"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",
"map" : "Physical Characteristics, attribute's value"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem",
"path" : "PackagedProductDefinition.packaging.containedItem",
"short" : "An item (inner package or manufactured item) within the packaging",
"definition" : "EMA IG 4.9 or 4.8.3",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packaging.containedItem",
"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",
"map" : "Package Item (Container).Manufactured Item, Package Item (Container).Device"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.id",
"path" : "PackagedProductDefinition.packaging.containedItem.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" : "PackagedProductDefinition.packaging.containedItem.extension",
"path" : "PackagedProductDefinition.packaging.containedItem.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" : "PackagedProductDefinition.packaging.containedItem.modifierExtension",
"path" : "PackagedProductDefinition.packaging.containedItem.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" : "PackagedProductDefinition.packaging.containedItem.item",
"path" : "PackagedProductDefinition.packaging.containedItem.item",
"short" : "The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package",
"definition" : "The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging.containedItem.item",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "CodeableReference",
"targetProfile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition",
"http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"
]
}
],
"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",
"map" : "(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount",
"path" : "PackagedProductDefinition.packaging.containedItem.amount",
"short" : "Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition",
"definition" : "EMA IG 4.11.2",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.packaging.containedItem.amount",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Quantity"
}
],
"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",
"map" : "Manufactured Item.Manufactured Item Quantity"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.id",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.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" : "PackagedProductDefinition.packaging.containedItem.amount.extension",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.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" : "PackagedProductDefinition.packaging.containedItem.amount.value",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.value",
"short" : "Numerical value (with implicit precision)",
"definition" : "The value of the measured amount. The value includes an implicit precision in the presentation of the value.",
"comment" : "The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).",
"requirements" : "Precision is handled implicitly in almost all cases of measurement.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "decimal"
}
],
"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" : "SN.2 / CQ - N/A"
},
{
"identity" : "rim",
"map" : "PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.comparator",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.comparator",
"short" : "< | <= | >= | > | ad - how to understand the value",
"definition" : "How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is \"<\" , then the real value is < stated value.",
"requirements" : "Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.comparator",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"meaningWhenMissing" : "If there is no comparator, then there is no modification of the value",
"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" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "QuantityComparator"
}
],
"strength" : "required",
"description" : "How the Quantity should be understood and represented.",
"valueSet" : "http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"
},
"mapping" : [
{
"identity" : "v2",
"map" : "SN.1 / CQ.1"
},
{
"identity" : "rim",
"map" : "IVL properties"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.unit",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "PackagedProductDefinition.packaging.containedItem.amount.unit",
"short" : "Unit representation",
"definition" : "A human-readable form of the unit.",
"requirements" : "There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.unit",
"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" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.unit"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.system",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.system",
"short" : "System that defines coded unit form",
"definition" : "The identification of the system that provides the coded form of the unit.",
"requirements" : "Need to know the system that defines the coded form of the unit.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"condition" : [
"qty-3"
],
"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" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "CO.codeSystem, PQ.translation.codeSystem"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.code",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.code",
"short" : "Coded form of the unit",
"definition" : "A computer processable form of the unit in some unit representation system.",
"comment" : "The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.",
"requirements" : "Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Quantity.code",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"condition" : [
"qty-3"
],
"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://unicom-project.eu/fhir/ValueSet/all-units-vs"
},
"mapping" : [
{
"identity" : "v2",
"map" : "(see OBX.6 etc.) / CQ.2"
},
{
"identity" : "rim",
"map" : "PQ.code, MO.currency, PQ.translation.code"
}
]
},
{
"id" : "PackagedProductDefinition.packaging.packaging",
"path" : "PackagedProductDefinition.packaging.packaging",
"short" : "Allows containers (and parts of containers) within containers, still as a part of single packaged product",
"definition" : "Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packaging.packaging",
"min" : 0,
"max" : "*"
},
"contentReference" : "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging",
"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",
"map" : "(link from Package Item (Container) to itself)"
}
]
},
{
"id" : "PackagedProductDefinition.characteristic",
"path" : "PackagedProductDefinition.characteristic",
"short" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\"",
"definition" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\", \"calendar pack\".",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.characteristic",
"min" : 0,
"max" : "*"
},
"contentReference" : "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property",
"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",
"map" : "n/a"
}
]
}
]
},
"differential" : {
"element" : [
{
"id" : "PackagedProductDefinition",
"path" : "PackagedProductDefinition"
},
{
"id" : "PackagedProductDefinition.identifier",
"path" : "PackagedProductDefinition.identifier",
"slicing" : {
"discriminator" : [
{
"type" : "pattern",
"path" : "system"
}
],
"rules" : "open"
},
"short" : "Identifier for the packaged product: PCID, national ID, or other",
"definition" : "Identifier for the packaged product: PCID, national code or other.",
"min" : 1
},
{
"id" : "PackagedProductDefinition.identifier:pcid",
"path" : "PackagedProductDefinition.identifier",
"sliceName" : "pcid",
"short" : "PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.",
"definition" : "EMA IG 4.1",
"min" : 1,
"max" : "1"
},
{
"id" : "PackagedProductDefinition.identifier:pcid.system",
"path" : "PackagedProductDefinition.identifier.system",
"min" : 1,
"patternUri" : "http://ema.europa.eu/example/pcid"
},
{
"id" : "PackagedProductDefinition.packageFor",
"path" : "PackagedProductDefinition.packageFor",
"min" : 1,
"type" : [
{
"code" : "Reference",
"targetProfile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"
]
}
]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity",
"path" : "PackagedProductDefinition.containedItemQuantity",
"short" : "Pack size. Repeated for combination packages.",
"definition" : "EMA IG 4.4",
"min" : 1
},
{
"id" : "PackagedProductDefinition.containedItemQuantity.code",
"path" : "PackagedProductDefinition.containedItemQuantity.code",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs"
}
},
{
"id" : "PackagedProductDefinition.description",
"path" : "PackagedProductDefinition.description",
"definition" : "EMA IG 4.2",
"min" : 1
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply",
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"short" : "Legal status of supply on the packaged product level.",
"definition" : "EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level",
"max" : "1"
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.code",
"path" : "PackagedProductDefinition.legalStatusOfSupply.code",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs"
}
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/country-ema-vs"
}
},
{
"id" : "PackagedProductDefinition.marketingStatus",
"path" : "PackagedProductDefinition.marketingStatus",
"definition" : "EMA IG 4.6"
},
{
"id" : "PackagedProductDefinition.marketingStatus.country",
"path" : "PackagedProductDefinition.marketingStatus.country",
"min" : 1
},
{
"id" : "PackagedProductDefinition.marketingStatus.country.coding",
"path" : "PackagedProductDefinition.marketingStatus.country.coding",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/country-ema-vs"
}
},
{
"id" : "PackagedProductDefinition.marketingStatus.status.coding.system",
"path" : "PackagedProductDefinition.marketingStatus.status.coding.system",
"patternUri" : "https://spor.ema.europa.eu/v1/lists/100000072052"
},
{
"id" : "PackagedProductDefinition.packaging",
"path" : "PackagedProductDefinition.packaging",
"min" : 1
},
{
"id" : "PackagedProductDefinition.packaging.type",
"path" : "PackagedProductDefinition.packaging.type",
"short" : "Container type",
"definition" : "EMA IG 4.8.1",
"min" : 1
},
{
"id" : "PackagedProductDefinition.packaging.type.coding.system",
"path" : "PackagedProductDefinition.packaging.type.coding.system",
"patternUri" : "https://spor.ema.europa.eu/v1/lists/100000073346"
},
{
"id" : "PackagedProductDefinition.packaging.quantity",
"path" : "PackagedProductDefinition.packaging.quantity",
"definition" : "EMA IG 4.8.5",
"min" : 1
},
{
"id" : "PackagedProductDefinition.packaging.material",
"path" : "PackagedProductDefinition.packaging.material",
"definition" : "EMA IG 4.8.7",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/material-vs"
}
},
{
"id" : "PackagedProductDefinition.packaging.shelfLifeStorage",
"path" : "PackagedProductDefinition.packaging.shelfLifeStorage",
"definition" : "EMA IG 4.12"
},
{
"id" : "PackagedProductDefinition.packaging.shelfLifeStorage.type",
"path" : "PackagedProductDefinition.packaging.shelfLifeStorage.type",
"min" : 1
},
{
"id" : "PackagedProductDefinition.packaging.shelfLifeStorage.type.coding.system",
"path" : "PackagedProductDefinition.packaging.shelfLifeStorage.type.coding.system",
"patternUri" : "https://spor.ema.europa.eu/v1/lists/100000073343"
},
{
"id" : "PackagedProductDefinition.packaging.shelfLifeStorage.period[x]",
"path" : "PackagedProductDefinition.packaging.shelfLifeStorage.period[x]",
"min" : 1
},
{
"id" : "PackagedProductDefinition.packaging.containedItem",
"path" : "PackagedProductDefinition.packaging.containedItem",
"short" : "An item (inner package or manufactured item) within the packaging",
"definition" : "EMA IG 4.9 or 4.8.3"
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.item",
"path" : "PackagedProductDefinition.packaging.containedItem.item",
"type" : [
{
"code" : "CodeableReference",
"targetProfile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition",
"http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"
]
}
]
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount",
"path" : "PackagedProductDefinition.packaging.containedItem.amount",
"short" : "Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition",
"definition" : "EMA IG 4.11.2"
},
{
"id" : "PackagedProductDefinition.packaging.containedItem.amount.code",
"path" : "PackagedProductDefinition.packaging.containedItem.amount.code",
"binding" : {
"strength" : "required",
"valueSet" : "http://unicom-project.eu/fhir/ValueSet/all-units-vs"
}
}
]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.