{ "description": "A record of authorization or compliance for one or more Products with a set of regulatory, policy, (pre-)qualification, or legal requirements.", "_filename": "StructureDefinition-ProductAuthorization.json", "package_name": "smart.who.int.pcmt", "date": "2025-06-26T06:29:23+00:00", "derivation": "specialization", "publisher": "WHO", "fhirVersion": "4.0.1", "name": "ProductAuthorization", "abstract": false, "type": "http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization", "experimental": null, "resourceType": "StructureDefinition", "title": "Product Authorization", "package_version": "0.1.0", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics", "valueCode": "can-be-target" } ], "snapshot": { "element": [ { "id": "ProductAuthorization", "max": "*", "min": 0, "base": { "max": "*", "min": 0, "path": "Base" }, "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.", "isModifier": false }, { "id": "ProductAuthorization.number", "max": "1", "min": 0, "base": { "max": "1", "min": 0, "path": "ProductAuthorization.number" }, "path": "ProductAuthorization.number", "type": [ { "code": "Identifier" } ], "short": "The identifier of the authorisation for the Products", "definition": "The identifier of the authorisation for the Products" }, { "path": "ProductAuthorization.status", "min": 1, "definition": "The status of the authoriation e.g. 'active' 'inactive'", "short": "Product status", "type": [ { "code": "code" } ], "binding": { "strength": "extensible", "valueSet": "http://smart.who.int/pcmt/ValueSet/Status" }, "max": "1", "id": "ProductAuthorization.status", "base": { "max": "1", "min": 1, "path": "ProductAuthorization.status" } }, { "path": "ProductAuthorization.type", "min": 1, "definition": "The type of authorization (e.g. pre-qualification)", "short": "Regulation type", "type": [ { "code": "code" } ], "binding": { "strength": "extensible", "valueSet": "http://smart.who.int/pcmt/ValueSet/RegulationType" }, "max": "1", "id": "ProductAuthorization.type", "base": { "max": "1", "min": 1, "path": "ProductAuthorization.type" } }, { "id": "ProductAuthorization.jurisdiction", "max": "*", "min": 1, "base": { "max": "*", "min": 1, "path": "ProductAuthorization.jurisdiction" }, "path": "ProductAuthorization.jurisdiction", "type": [ { "code": "CodeableConcept" } ], "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" }, { "id": "ProductAuthorization.holder", "max": "1", "min": 1, "base": { "max": "1", "min": 1, "path": "ProductAuthorization.holder" }, "path": "ProductAuthorization.holder", "type": [ { "code": "Reference", "targetProfile": [ "https://profiles.ihe.net/ITI/mCSD/StructureDefinition/IHE.mCSD.Organization" ] } ], "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" }, { "id": "ProductAuthorization.product", "max": "*", "min": 1, "base": { "max": "*", "min": 1, "path": "ProductAuthorization.product" }, "path": "ProductAuthorization.product", "type": [ { "code": "Reference", "targetProfile": [ "http://smart.who.int/pcmt/StructureDefinition/Product" ] } ], "short": "Products that are covered under this authorization", "definition": "Products that are covered under this authorization" }, { "id": "ProductAuthorization.validityPeriod", "max": "1", "min": 0, "base": { "max": "1", "min": 0, "path": "ProductAuthorization.validityPeriod" }, "path": "ProductAuthorization.validityPeriod", "type": [ { "code": "Period" } ], "short": "Validity Period of this authorization", "definition": "Validity Period of this authorization" } ], "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version", "valueString": "4.0.1" } ] }, "status": "draft", "id": "2c1c56b1-fd2d-48a2-8b21-e68e7aa80811", "kind": "logical", "url": "http://smart.who.int/pcmt/StructureDefinition/ProductAuthorization", "version": "0.1.0", "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", "max": "1", "min": 0, "path": "ProductAuthorization.number", "type": [ { "code": "Identifier" } ], "short": "The identifier of the authorisation for the Products", "definition": "The identifier of the authorisation for the Products" }, { "id": "ProductAuthorization.status", "max": "1", "min": 1, "path": "ProductAuthorization.status", "type": [ { "code": "code" } ], "short": "Product status", "binding": { "strength": "extensible", "valueSet": "http://smart.who.int/pcmt/ValueSet/Status" }, "definition": "The status of the authoriation e.g. 'active' 'inactive' " }, { "id": "ProductAuthorization.type", "max": "1", "min": 1, "path": "ProductAuthorization.type", "type": [ { "code": "code" } ], "short": "Regulation type", "binding": { "strength": "extensible", "valueSet": "http://smart.who.int/pcmt/ValueSet/RegulationType" }, "definition": "The type of authorization (e.g. pre-qualification)" }, { "id": "ProductAuthorization.jurisdiction", "max": "*", "min": 1, "path": "ProductAuthorization.jurisdiction", "type": [ { "code": "CodeableConcept" } ], "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" }, { "id": "ProductAuthorization.holder", "max": "1", "min": 1, "path": "ProductAuthorization.holder", "type": [ { "code": "Reference", "targetProfile": [ "https://profiles.ihe.net/ITI/mCSD/StructureDefinition/IHE.mCSD.Organization" ] } ], "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" }, { "id": "ProductAuthorization.product", "max": "*", "min": 1, "path": "ProductAuthorization.product", "type": [ { "code": "Reference", "targetProfile": [ "http://smart.who.int/pcmt/StructureDefinition/Product" ] } ], "short": "Products that are covered under this authorization", "definition": "Products that are covered under this authorization" }, { "id": "ProductAuthorization.validityPeriod", "max": "1", "min": 0, "path": "ProductAuthorization.validityPeriod", "type": [ { "code": "Period" } ], "short": "Validity Period of this authorization", "definition": "Validity Period of this authorization" } ] }, "contact": [ { "name": "WHO", "telecom": [ { "value": "http://who.int", "system": "url" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Base" }