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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ed38e7e5-235e-460e-b292-f6c220622d1c"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1"^^xsd:anyURI ; fhir:link <http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1> ] [ fhir:v "http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5"^^xsd:anyURI ; fhir:link <http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5> ] ) # this will exist but is commented out in the IG temporarily , profile value=\"http:\/\/hl7.org\/fhir\/5.0\/StructureDefinition\/Bundle\" \/ ] ; # fhir:type [ fhir:v "transaction-response"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "MedicinalProductDefinition/600000709068"^^xsd:anyURI ] ] ] [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/PackagedProductDefinition/7868766"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/PackagedProductDefinition/7868766> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "PackagedProductDefinition/7868766"^^xsd:anyURI ] ] ] [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/ActivityDefinition/7371703"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/ActivityDefinition/7371703> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "ActivityDefinition/7371703"^^xsd:anyURI ] ] ] [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/RegulatedAuthorization/6756012"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/RegulatedAuthorization/6756012> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "RegulatedAuthorization/6756012"^^xsd:anyURI ] ] ] [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/RegulatedAuthorization/6362767"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/RegulatedAuthorization/6362767> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "RegulatedAuthorization/6362767"^^xsd:anyURI ] ] ] [ fhir:fullUrl [ fhir:v "http://ema.europa.eu/example/api/RegulatedAuthorization/6094279"^^xsd:anyURI ] ; ( fhir:resource <http://ema.europa.eu/example/api/RegulatedAuthorization/6094279> ) ; fhir:response [ fhir:status [ fhir:v "200" ] ; fhir:location [ fhir:v "RegulatedAuthorization/6094279"^^xsd:anyURI ] ] ] ) . # <http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "600000709068"] ; # fhir:meta [ fhir:versionId [ fhir:v "4" ] ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir: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></div>"^^rdf:XMLLiteral ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/authorisedDoseForm"^^xsd:anyURI ] ; fhir:value [ a fhir:Coding ; ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 38 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000000004"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073683" ] ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://spor.azure-api.net/pms/api/v2"^^xsd:anyURI ] ; fhir:value [ fhir:v "6055417" ] ] [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"^^xsd:anyURI ] ; fhir:value [ fhir:v "PRD417562" ] ] ) ; # fhir:domain [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 7 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000004"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000000012" ] ] ) ] ; # fhir:status [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000005003"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000005007" ] ] ) ] ; # fhir:combinedPharmaceuticalDoseForm [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 38 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000000006"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073683" ] ] ) ] ; # fhir:additionalMonitoringIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://ema.europa.eu/fhir/additionalMonitoringIndicator"^^xsd:anyURI ] ; fhir:code [ fhir:v "False" ] ] ) ] ; # fhir:pediatricUseIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://ema.europa.eu/fhir/paediatricUseIndicator"^^xsd:anyURI ] ; fhir:code [ fhir:v "True" ] ] ) ] ; # fhir:classification ( [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000093533"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000098024" ] ] ) ] [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 8 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000116045"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000116046" ] ] ) ] [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 2 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000000324"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003517" ] ] ) ] ) ; # fhir:attachedDocument ( [ fhir:reference [ fhir:v "DocumentReference/13709" ] ] ) ; # fhir:masterFile ( [ fhir:reference [ fhir:v "DocumentReference/mf1" ] ] ) ; # fhir:contact ( [ fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000154441"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000017719" ] ] ) ] ; fhir:contact [ fhir:reference [ fhir:v "Organization/phv5633366" ] ] ] [ fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 1 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000154441"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155057" ] ] ) ] ; fhir:contact [ fhir:reference [ fhir:v "PractitionerRole/qppv5633367" ] ] ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "StopCold 5 mg/120 mg comprimidos de liberación prolongada." ] ; ( fhir:part [ fhir:part [ fhir:v "StopCold" ] ; fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 9 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ] ) ] ] [ fhir:part [ fhir:v "5 MG/120 MG" ] ; fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 9 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ] ) ] ] [ fhir:part [ fhir:v "COMPRIMIDOS DE LIBERACIÓN PROLONGADA" ] ; fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 8 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 19 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000002"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000000529" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "es" ] ] [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 2 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000072057"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072264" ] ] ) # language needs an international code, which matches the RMS code ] ] ) ] ) ; # fhir:operation ( [ fhir:id [ fhir:v "6519944" ] ; fhir:type [ fhir:reference [ fhir:reference [ fhir:v "ActivityDefinition/7371703" ] ] ] ; fhir:confidentialityIndicator [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000004983"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000004984" ] ] ) ] ] ) . # <http://ema.europa.eu/example/api/PackagedProductDefinition/7868766> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "7868766"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>: 40(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>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"^^xsd:anyURI ] ; fhir:value [ fhir:v "PRD417562" ] ] ) ; # fhir:packageFor ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/600000709068" ] ] ) ; # fhir:status [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000005003"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000005007" ] ] ) ] ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "40"^^xsd:decimal ] ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000000014"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000002152" ] ] ) ; # fhir:description [ fhir:v "5MG/120MG PROLONGED RELEASE TABLET" ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/language"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "es" ] # language needs an international code, which matches the RMS code ] [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/language"^^xsd:anyURI ] ; fhir:value [ a fhir:Coding ; ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 2 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000072057"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072264" ] ] ] ) ] . # <http://ema.europa.eu/example/api/ActivityDefinition/7371703> a fhir:ActivityDefinition ; fhir:id [ fhir:v "7371703"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir: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>"^^rdf:XMLLiteral ] ; # fhir:status [ fhir:v "active"] ; # fhir:effectivePeriod [ fhir:start [ fhir:v "2024-12-01"^^xsd:date ] ] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000160406"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000160478" ] ] ) ] ; # fhir:participant ( [ fhir:type [ fhir:v "organization" ] ; fhir:typeReference [ fhir:identifier [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ] ; fhir:value [ fhir:v "LOC-100068457" ] ] ; fhir:display [ fhir:v "1 4 U Pharma GmbH" ] ] ] ) . # <http://ema.europa.eu/example/api/RegulatedAuthorization/6756012> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "6756012"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/fhir/MarketingAuthorizationNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "62.102" ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/600000709068" ] ] ) ; # fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 1 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000060"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000061" ] ] ) ] ; # fhir:region ( [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 22 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000002"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000000529" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000072049"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000032263" ] ] ) ] ; # fhir:statusDate [ fhir:v "2025-02-18T00:00:00Z"^^xsd:dateTime] ; # fhir:holder [ fhir:identifier [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ] ; fhir:value [ fhir:v "LOC-100002956" ] ] ; fhir:display [ fhir:v "Kern Pharma S.L." ] ] ; # fhir:regulator [ fhir:identifier [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ] ; fhir:value [ fhir:v "ES" ] ] ; fhir:display [ fhir:v "ES" ] ] ; # fhir:case [ fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 14 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000154442"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155062" ] ] ) ] ] . # <http://ema.europa.eu/example/api/RegulatedAuthorization/6362767> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "6362767"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>"^^rdf:XMLLiteral ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/fhir/MarketingAuthorizationNumber"^^xsd:anyURI ] ; fhir:value [ fhir:v "62.102" ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "PackagedProductDefinition/7868766" ] ] ) ; # fhir:type [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 1 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000060"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000061" ] ] ) ] ; # fhir:region ( [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 22 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000000002"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000000529" ] ] ) ] ) ; # fhir:status [ ( fhir:coding [ ( fhir:extension [ fhir:url [ fhir:v "http://ema.europa.eu/fhir/extension/termVersion"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 3 ] ] ) ; fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000072049"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000032263" ] ] ) ] ; # fhir:statusDate [ fhir:v "2025-02-18T00:00:00Z"^^xsd:dateTime] . # <http://ema.europa.eu/example/api/RegulatedAuthorization/6094279> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "6094279"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>"^^rdf:XMLLiteral ] ; # fhir:subject ( [ fhir:reference [ fhir:v "ActivityDefinition/7371703" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/220000000060"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000099" ] ] ) ] ; # fhir:validityPeriod [ fhir:start [ fhir:v "2024-12-01"^^xsd:date ] ] ; # fhir:regulator [ fhir:identifier [ fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/locations"^^xsd:anyURI ] ; fhir:value [ fhir:v "LOC-100000015" ] ] ; fhir:display [ fhir:v "Finnish Medicines Agency" ] ] . #
IG © 2025 EMA. Package emavar#1.0.0 based on FHIR 5.0.0. Generated 2025-04-04
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