| Package | smart.who.int.pcmt |
| Resource Type | StructureDefinition |
| Id | ProductAuthorization |
| FHIR Version | R4 |
| Source | http://smart.who.int/pcmt/https://build.fhir.org/ig/WorldHealthOrganization/smart-pcmt/StructureDefinition-ProductAuthorization.html |
| URL | http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization |
| Version | 0.2.0 |
| Status | draft |
| Date | 2025-07-01T08:14:20+00:00 |
| Name | ProductAuthorization |
| Title | Product Authorization |
| Authority | who |
| Description | A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements. |
| Type | http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization |
| Kind | logical |
No resources found
| StructureDefinition | |
| Product | Product |
| IHE.mCSD.Organization | mCSD Organization |
| ValueSet | |
| RegulationType | Regulation Type for a Regulated Product |
| Status | Status for a Product |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition ProductAuthorization
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ProductAuthorization | 0..* | Base | Product Authorization Instances of this logical model can be the target of a Reference | |
  number | 0..1 | Identifier | The identifier of the authorisation for the Products | |
 status | 1..1 | code | Product status Binding: Status for a Product (extensible) | |
| type | 1..1 | code | Regulation type Binding: Regulation Type for a Regulated Product (extensible) | |
| jurisdiction | 1..* | CodeableConcept | The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued | |
 holder | 1..1 | Reference(mCSD Organization) | The organisation responsible for the product i.e. the grantee of the authorisation | |
| product | 1..* | Reference(Product) | Products that are covered under this authorization | |
 validityPeriod | 0..1 | Period | Validity Period of this authorization | |
| Documentation for this format | ||||
FHIR{
"resourceType": "StructureDefinition",
"id": "ProductAuthorization",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-be-target"
}
],
"url": "http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization",
"version": "0.2.0",
"name": "ProductAuthorization",
"title": "Product Authorization",
"status": "draft",
"date": "2025-07-01T08:14:20+00:00",
"publisher": "WHO",
"contact": [
{
"name": "WHO",
"telecom": [
{
"system": "url",
"value": "http://who.int"
}
]
}
],
"description": "A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.",
"fhirVersion": "4.0.1",
"kind": "logical",
"abstract": false,
"type": "http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Base",
"derivation": "specialization",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
}
],
"element": [
{
"id": "ProductAuthorization",
"path": "ProductAuthorization",
"short": "Product Authorization",
"definition": "A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.",
"min": 0,
"max": "*",
"base": {
"path": "Base",
"min": 0,
"max": "*"
},
"isModifier": false
},
{
"id": "ProductAuthorization.number",
"path": "ProductAuthorization.number",
"short": "The identifier of the authorisation for the Products",
"definition": "The identifier of the authorisation for the Products",
"min": 0,
"max": "1",
"base": {
"path": "ProductAuthorization.number",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
]
},
{
"id": "ProductAuthorization.status",
"path": "ProductAuthorization.status",
"short": "Product status",
"definition": "The status of the authoriation e.g. 'active' 'inactive'",
"min": 1,
"max": "1",
"base": {
"path": "ProductAuthorization.status",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"binding": {
"strength": "extensible",
"valueSet": "http://smart.who.int/pcmt/ValueSet/Status"
}
},
{
"id": "ProductAuthorization.type",
"path": "ProductAuthorization.type",
"short": "Regulation type",
"definition": "The type of authorization (e.g. pre-qualification)",
"min": 1,
"max": "1",
"base": {
"path": "ProductAuthorization.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"binding": {
"strength": "extensible",
"valueSet": "http://smart.who.int/pcmt/ValueSet/RegulationType"
}
},
{
"id": "ProductAuthorization.jurisdiction",
"path": "ProductAuthorization.jurisdiction",
"short": "The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued",
"definition": "The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued",
"min": 1,
"max": "*",
"base": {
"path": "ProductAuthorization.jurisdiction",
"min": 1,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductAuthorization.holder",
"path": "ProductAuthorization.holder",
"short": "The organisation responsible for the product i.e. the grantee of the authorisation",
"definition": "The organisation responsible for the product i.e. the grantee of the authorisation",
"min": 1,
"max": "1",
"base": {
"path": "ProductAuthorization.holder",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"https://profiles.ihe.net/ITI/mCSD/StructureDefinition/IHE.mCSD.Organization"
]
}
]
},
{
"id": "ProductAuthorization.product",
"path": "ProductAuthorization.product",
"short": "Products that are covered under this authorization",
"definition": "Products that are covered under this authorization",
"min": 1,
"max": "*",
"base": {
"path": "ProductAuthorization.product",
"min": 1,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://smart.who.int/pcmt/StructureDefinition/Product"
]
}
]
},
{
"id": "ProductAuthorization.validityPeriod",
"path": "ProductAuthorization.validityPeriod",
"short": "Validity Period of this authorization",
"definition": "Validity Period of this authorization",
"min": 0,
"max": "1",
"base": {
"path": "ProductAuthorization.validityPeriod",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
]
}
]
},
"differential": {
"element": [
{
"id": "ProductAuthorization",
"path": "ProductAuthorization",
"short": "Product Authorization",
"definition": "A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements."
},
{
"id": "ProductAuthorization.number",
"path": "ProductAuthorization.number",
"short": "The identifier of the authorisation for the Products",
"definition": "The identifier of the authorisation for the Products",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
]
},
{
"id": "ProductAuthorization.status",
"path": "ProductAuthorization.status",
"short": "Product status",
"definition": "The status of the authoriation e.g. 'active' 'inactive' ",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"binding": {
"strength": "extensible",
"valueSet": "http://smart.who.int/pcmt/ValueSet/Status"
}
},
{
"id": "ProductAuthorization.type",
"path": "ProductAuthorization.type",
"short": "Regulation type",
"definition": "The type of authorization (e.g. pre-qualification)",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"binding": {
"strength": "extensible",
"valueSet": "http://smart.who.int/pcmt/ValueSet/RegulationType"
}
},
{
"id": "ProductAuthorization.jurisdiction",
"path": "ProductAuthorization.jurisdiction",
"short": "The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued",
"definition": "The jurisidiction(s) (e.g. country, economic commuinity or region) where the authorisation is issued",
"min": 1,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductAuthorization.holder",
"path": "ProductAuthorization.holder",
"short": "The organisation responsible for the product i.e. the grantee of the authorisation",
"definition": "The organisation responsible for the product i.e. the grantee of the authorisation",
"min": 1,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"https://profiles.ihe.net/ITI/mCSD/StructureDefinition/IHE.mCSD.Organization"
]
}
]
},
{
"id": "ProductAuthorization.product",
"path": "ProductAuthorization.product",
"short": "Products that are covered under this authorization",
"definition": "Products that are covered under this authorization",
"min": 1,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://smart.who.int/pcmt/StructureDefinition/Product"
]
}
]
},
{
"id": "ProductAuthorization.validityPeriod",
"path": "ProductAuthorization.validityPeriod",
"short": "Validity Period of this authorization",
"definition": "Validity Period of this authorization",
"min": 0,
"max": "1",
"type": [
{
"code": "Period"
}
]
}
]
}
}