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 "490a41c4-5f57-4444-80f7-e2734b193dc3"] ; #
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> ] ) # 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"] ; #
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:request [
fhir:method [ fhir:v "PUT" ] ;
fhir:url [ fhir:v "MedicinalProductDefinition/600000709068"^^xsd:anyURI ] ]
] [
fhir:fullUrl [ fhir:v "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "ActivityDefinition"^^xsd:anyURI ] ]
] [
fhir:fullUrl [ fhir:v "urn:uuid:34aac3e5-6c44-45fd-9a57-4c3cb638a13c"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:34aac3e5-6c44-45fd-9a57-4c3cb638a13c> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "RegulatedAuthorization"^^xsd:anyURI ] ]
] ) . #
<http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068> a fhir:MedicinalProductDefinition ;
fhir:id [ fhir:v "600000709068"] ; #
fhir:meta [
fhir:versionId [ fhir:v "3" ]
] ; #
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: 3</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-490a41c4-5f57-4444-80f7-e2734b193dc3.html#urn-uuid-a57ef872-40cf-4bc8-a486-211ba46f367f\">Bundle: type = transaction</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>"^^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" ] ] ) ]
] [
fhir:type [
fhir:reference [
fhir:reference [ fhir:v "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f" ] ] ] ;
fhir:confidentialityIndicator [
( fhir:coding [
fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000004983"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000004985" ] ] ) ]
] ) . #
<urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f> a fhir:ActivityDefinition ;
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ActivityDefinition_null\"> </a>\n<div>\n <table class=\"grid dict\">\n\n \n\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>"^^rdf:XMLLiteral
] ; #
fhir:status [ fhir:v "active"] ; #
fhir:effectivePeriod [
fhir:start [ fhir:v "2025-03-31"^^xsd:date ]
] ; #
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000160406"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000160480" ] ] )
] ; #
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-100068460" ] ] ;
fhir:display [ fhir:v "Pharma X" ] ]
] ) . #
<urn:uuid:34aac3e5-6c44-45fd-9a57-4c3cb638a13c> a fhir:RegulatedAuthorization ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_null\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization </b></p><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/manufacturingAuthorizationNumber</code>/12345</p><p><b>subject</b>: <a href=\"Bundle-490a41c4-5f57-4444-80f7-e2734b193dc3.html#urn-uuid-a57ef872-40cf-4bc8-a486-211ba46f367f\">Bundle: type = transaction</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>"^^rdf:XMLLiteral
] ; #
fhir:identifier ( [
fhir:system [ fhir:v "http://ema.europa.eu/fhir/manufacturingAuthorizationNumber"^^xsd:anyURI ] ;
fhir:value [ fhir:v "12345" ]
] ) ; #
fhir:subject ( [
fhir:reference [ fhir:v "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f" ]
] ) ; #
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 "2025-03-31"^^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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