EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "e4760773-4635-4f49-8f3f-4d085f049199",
"meta" : {
"profile" : [
"http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1",
"http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5"
]
},
"type" : "transaction-response",
"entry" : [
// this will exist but is commented out in the IG temporarily
// profile value="http://hl7.org/fhir/5.0/StructureDefinition/Bundle" /
{
"fullUrl" : "http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "600000709068",
"meta" : {
"versionId" : "4"
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_600000709068\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 600000709068</b></p><a name=\"600000709068\"> </a><a name=\"hc600000709068\"> </a><a name=\"600000709068-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 4</p></div><p><b>Authorised Dose Form</b>: <a href=\"CodeSystem-200000000004.html#200000000004-100000073683\">Pharmaceutical Dose Form 100000073683</a>: Prolonged-release tablet</p><p><b>identifier</b>: <code>http://spor.azure-api.net/pms/api/v2</code>/6055417, <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>domain</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}\">Nullified</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000000006 100000073683}\">Prolonged-release tablet</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://ema.europa.eu/fhir/additionalMonitoringIndicator False}\">False</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://ema.europa.eu/fhir/paediatricUseIndicator True}\">True</span></p><p><b>classification</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000093533 100000098024}\">100000098024</span>, <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000116045 100000116046}\">Full application (Article 8(3) of Directive No 2001/83/EC)</span>, <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000000324 200000003517}\">Other</span></p><p><b>attachedDocument</b>: <a href=\"DocumentReference-13709.html\">DocumentReference: status = current</a></p><p><b>masterFile</b>: <a href=\"DocumentReference-mf1.html\">DocumentReference: status = current</a></p><blockquote><p><b>contact</b></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 200000017719}\">Pharmacovigilance Enquiry Information</span></p><p><b>contact</b>: <a href=\"Organization-phv5633366.html\">Organization Dummmy Organization</a></p></blockquote><blockquote><p><b>contact</b></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 100000155057}\">Qualified Person in the EEA for Pharmacovigilance</span></p><p><b>contact</b>: <a href=\"PractitionerRole-qppv5633367.html\">PractitionerRole </a></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: StopCold 5 mg/120 mg comprimidos de liberación prolongada.</p><blockquote><p><b>part</b></p><p><b>part</b>: StopCold</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 5 MG/120 MG</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: COMPRIMIDOS DE LIBERACIÓN PROLONGADA</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}\">Spain</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 es}, {http://spor.ema.europa.eu/v1/lists/100000072057 100000072264}\">Spanish</span></td></tr></table></blockquote><blockquote><p><b>operation</b></p><blockquote><p><b>id</b></p>6519944</blockquote><h3>Types</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ActivityDefinition-7371703.html\">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004984}\">Confidential</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-e4760773-4635-4f49-8f3f-4d085f049199.html#ActivityDefinition_123456\">Bundle: type = transaction-response</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004985}\">Public</span></p></blockquote></div>"
},
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/authorisedDoseForm",
"valueCoding" : {
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 38
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073683"
}
}
],
"identifier" : [
{
"system" : "http://spor.azure-api.net/pms/api/v2",
"value" : "6055417"
},
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665",
"value" : "PRD417562"
}
],
"domain" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 7
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000000004",
"code" : "100000000012"
}
]
},
"status" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/200000005003",
"code" : "200000005007"
}
]
},
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 38
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/200000000006",
"code" : "100000073683"
}
]
},
"additionalMonitoringIndicator" : {
"coding" : [
{
"system" : "http://ema.europa.eu/fhir/additionalMonitoringIndicator",
"code" : "False"
}
]
},
"pediatricUseIndicator" : {
"coding" : [
{
"system" : "http://ema.europa.eu/fhir/paediatricUseIndicator",
"code" : "True"
}
]
},
"classification" : [
{
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000093533",
"code" : "100000098024"
}
]
},
{
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 8
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000116045",
"code" : "100000116046"
}
]
},
{
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 2
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/200000000324",
"code" : "200000003517"
}
]
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/13709"
}
],
"masterFile" : [
{
🔗 "reference" : "DocumentReference/mf1"
}
],
"contact" : [
{
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000154441",
"code" : "200000017719"
}
]
},
"contact" : {
🔗 "reference" : "Organization/phv5633366"
}
},
{
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 1
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000154441",
"code" : "100000155057"
}
]
},
"contact" : {
🔗 "reference" : "PractitionerRole/qppv5633367"
}
}
],
"name" : [
{
"productName" : "StopCold 5 mg/120 mg comprimidos de liberación prolongada.",
"part" : [
{
"part" : "StopCold",
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 9
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000002"
}
]
}
},
{
"part" : "5 MG/120 MG",
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 9
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000004"
}
]
}
},
{
"part" : "COMPRIMIDOS DE LIBERACIÓN PROLONGADA",
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 8
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000005"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 19
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000529"
}
]
},
"language" : {
"coding" : [
// language needs an international code, which matches the RMS code
{
"system" : "urn:ietf:bcp:47",
"code" : "es"
},
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 2
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000072057",
"code" : "100000072264"
}
]
}
}
]
}
],
"operation" : [
{
"id" : "6519944",
"type" : {
"reference" : {
🔗 "reference" : "ActivityDefinition/7371703"
}
},
"confidentialityIndicator" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000004983",
"code" : "200000004984"
}
]
}
},
{
"type" : {
"reference" : {
"reference" : "ActivityDefinition/123456"
}
},
"confidentialityIndicator" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000004983",
"code" : "200000004985"
}
]
}
}
]
},
"response" : {
"status" : "200",
"location" : "MedicinalProductDefinition/600000709068"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/PackagedProductDefinition/7868766",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "7868766",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_7868766\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition 7868766</b></p><a name=\"7868766\"> </a><a name=\"hc7868766\"> </a><a name=\"7868766-en-US\"> </a><p><b>identifier</b>: <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>packageFor</b>: <a href=\"Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068\">Bundle: type = searchset</a></p><p><b>status</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}\">Nullified</span></p><p><b>containedItemQuantity</b>: 20(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014)<span style=\"background: LightGoldenRodYellow\"> (Details: Units Of Presentation code200000002152 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>5MG/120MG PROLONGED RELEASE TABLET</p>\n</div></div>"
},
"identifier" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665",
"value" : "PRD417562"
}
],
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/600000709068"
}
],
"status" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/200000005003",
"code" : "200000005007"
}
]
},
"containedItemQuantity" : [
{
"value" : 20,
"system" : "http://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
],
"description" : "5MG/120MG PROLONGED RELEASE TABLET",
"_description" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/language",
"valueCode" : "es"
},
// language needs an international code, which matches the RMS code
{
"url" : "http://ema.europa.eu/fhir/extension/language",
"valueCoding" : {
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 2
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000072057",
"code" : "100000072264"
}
}
]
}
},
"response" : {
"status" : "200",
"location" : "PackagedProductDefinition/7868766"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/ActivityDefinition/123456",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "123456",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ActivityDefinition_123456\"> </a>\n<div>\n <table class=\"grid dict\">\n\n \n\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">123456</td>\n </tr>\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Effective Period: </b></th>\n <td style=\"padding-left: 4px;\">2025-03-31..</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n \n \n\n \n <tr>\n <th scope=\"row\"><b>Code: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p><b>system: </b><span><a href=\"CodeSystem-100000160406.html\">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>\n \n \n <p><b>code: </b><span>100000160480</span></p>\n \n \n \n \n \n </td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n </table>\n</div>\n</div>"
},
"status" : "active",
"effectivePeriod" : {
"start" : "2025-03-31"
},
"code" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000160406",
"code" : "100000160480"
}
]
},
"participant" : [
{
"type" : "organization",
"typeReference" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100068460"
},
"display" : "Pharma X"
}
}
]
},
"response" : {
"status" : "200",
"location" : "ActivityDefinition/123456"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/RegulatedAuthorization/345678",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "345678",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_345678\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization 345678</b></p><a name=\"345678\"> </a><a name=\"hc345678\"> </a><a name=\"345678-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/manufacturingAuthorizationNumber</code>/12345</p><p><b>subject</b>: <a href=\"Bundle-e4760773-4635-4f49-8f3f-4d085f049199.html#ActivityDefinition_123456\">Bundle: type = transaction-response</a></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}\">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2025-03-31 --> (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/manufacturingAuthorizationNumber",
"value" : "12345"
}
],
"subject" : [
{
"reference" : "ActivityDefinition/123456"
}
],
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000099"
}
]
},
"validityPeriod" : {
"start" : "2025-03-31"
},
"regulator" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100000015"
},
"display" : "Finnish Medicines Agency"
}
},
"response" : {
"status" : "200",
"location" : "RegulatedAuthorization/345678"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/ActivityDefinition/7371703",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "7371703",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ActivityDefinition_7371703\"> </a>\n<div>\n <table class=\"grid dict\">\n\n \n\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">7371703</td>\n </tr>\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Effective Period: </b></th>\n <td style=\"padding-left: 4px;\">2024-12-01..</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n \n \n\n \n <tr>\n <th scope=\"row\"><b>Code: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p><b>system: </b><span><a href=\"CodeSystem-100000160406.html\">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>\n \n \n <p><b>code: </b><span>100000160478</span></p>\n \n \n \n \n \n </td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n </table>\n</div>\n</div>"
},
"status" : "active",
"effectivePeriod" : {
"start" : "2024-12-01"
},
"code" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000160406",
"code" : "100000160478"
}
]
},
"participant" : [
{
"type" : "organization",
"typeReference" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100068457"
},
"display" : "1 4 U Pharma GmbH"
}
}
]
},
"response" : {
"status" : "200",
"location" : "ActivityDefinition/7371703"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/RegulatedAuthorization/6756012",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "6756012",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_6756012\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization 6756012</b></p><a name=\"6756012\"> </a><a name=\"hc6756012\"> </a><a name=\"6756012-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href=\"Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068\">Bundle: type = searchset</a></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}\">Spain</span></p><p><b>status</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}\">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p><p><b>holder</b>: Kern Pharma S.L. (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100002956)</p><p><b>regulator</b>: ES (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/ES)</p><h3>Cases</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000154442 100000155062}\">National Procedure</span></td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/MarketingAuthorizationNumber",
"value" : "62.102"
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/600000709068"
}
],
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 1
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000061"
}
]
},
"region" : [
{
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 22
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000529"
}
]
}
],
"status" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000072049",
"code" : "200000032263"
}
]
},
"statusDate" : "2025-02-18T00:00:00Z",
"holder" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100002956"
},
"display" : "Kern Pharma S.L."
},
"regulator" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "ES"
},
"display" : "ES"
},
"case" : {
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 14
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000154442",
"code" : "100000155062"
}
]
}
}
},
"response" : {
"status" : "200",
"location" : "RegulatedAuthorization/6756012"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/RegulatedAuthorization/6362767",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "6362767",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_6362767\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization 6362767</b></p><a name=\"6362767\"> </a><a name=\"hc6362767\"> </a><a name=\"6362767-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href=\"Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#PackagedProductDefinition_7868766\">Bundle: type = searchset</a></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}\">Spain</span></p><p><b>status</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}\">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/MarketingAuthorizationNumber",
"value" : "62.102"
}
],
"subject" : [
{
"reference" : "PackagedProductDefinition/7868766"
}
],
"type" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 1
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000061"
}
]
},
"region" : [
{
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 22
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000529"
}
]
}
],
"status" : {
"coding" : [
{
"extension" : [
{
"url" : "http://ema.europa.eu/fhir/extension/termVersion",
"valueInteger" : 3
}
],
"system" : "http://spor.ema.europa.eu/v1/lists/100000072049",
"code" : "200000032263"
}
]
},
"statusDate" : "2025-02-18T00:00:00Z"
},
"response" : {
"status" : "200",
"location" : "RegulatedAuthorization/6362767"
}
},
{
"fullUrl" : "http://ema.europa.eu/example/api/RegulatedAuthorization/6094279",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "6094279",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_6094279\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization 6094279</b></p><a name=\"6094279\"> </a><a name=\"hc6094279\"> </a><a name=\"6094279-en-US\"> </a><p><b>subject</b>: <a href=\"ActivityDefinition-7371703.html\">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}\">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2024-12-01 --> (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>"
},
"subject" : [
{
🔗 "reference" : "ActivityDefinition/7371703"
}
],
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000099"
}
]
},
"validityPeriod" : {
"start" : "2024-12-01"
},
"regulator" : {
"identifier" : {
"system" : "http://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100000015"
},
"display" : "Finnish Medicines Agency"
}
},
"response" : {
"status" : "200",
"location" : "RegulatedAuthorization/6094279"
}
}
]
}