EMA Write PMS API Implementation Guide - Enrichments
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Active as of 2025-04-04

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@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:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "100000155531"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "5.0.0" ] ;
fhir:lastUpdated [ fhir:v "2023-08-03T11:35:00.198Z"^^xsd:dateTime ]
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 100000155531</b></p><a name=\"100000155531\"> </a><a name=\"hc100000155531\"> </a><a name=\"100000155531-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: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000155531</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">100000155532<a name=\"100000155531-100000155532\"> </a></td><td>Summary of Product Characteristics</td></tr><tr><td style=\"white-space:nowrap\">100000155533<a name=\"100000155531-100000155533\"> </a></td><td>Annex II</td></tr><tr><td style=\"white-space:nowrap\">100000155534<a name=\"100000155531-100000155534\"> </a></td><td>Outer Packaging</td></tr><tr><td style=\"white-space:nowrap\">100000155535<a name=\"100000155531-100000155535\"> </a></td><td>Labelling</td></tr><tr><td style=\"white-space:nowrap\">100000155536<a name=\"100000155531-100000155536\"> </a></td><td>Immediate Packaging</td></tr><tr><td style=\"white-space:nowrap\">100000155537<a name=\"100000155531-100000155537\"> </a></td><td>Other Product Information</td></tr><tr><td style=\"white-space:nowrap\">100000155538<a name=\"100000155531-100000155538\"> </a></td><td>Package Leaflet</td></tr><tr><td style=\"white-space:nowrap\">100000155539<a name=\"100000155531-100000155539\"> </a></td><td>Combined File of all Documents</td></tr><tr><td style=\"white-space:nowrap\">100000155540<a name=\"100000155531-100000155540\"> </a></td><td>Mock ups</td></tr><tr><td style=\"white-space:nowrap\">100000155541<a name=\"100000155531-100000155541\"> </a></td><td>Appendix V</td></tr><tr><td style=\"white-space:nowrap\">200000017121<a name=\"100000155531-200000017121\"> </a></td><td>Package Leaflet and Labelling</td></tr><tr><td style=\"white-space:nowrap\">200000027914<a name=\"100000155531-200000027914\"> </a></td><td>Specimens</td></tr><tr><td style=\"white-space:nowrap\">200000027915<a name=\"100000155531-200000027915\"> </a></td><td>List of all authorised presentations (Annex A)</td></tr><tr><td style=\"white-space:nowrap\">200000027916<a name=\"100000155531-200000027916\"> </a></td><td>Restrictions posed by Member States (Annex 127a)</td></tr></table></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000155531"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:name [ fhir:v "DocumentTypeCs"] ; # 
  fhir:title [ fhir:v "Document Type"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2025-04-04T16:15:09+01:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "EMA"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "EMA" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://support.ema.europa.eu/esc" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Document Type"] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "14"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "100000155532" ] ;
fhir:display [ fhir:v "Summary of Product Characteristics" ]
  ] [
fhir:code [ fhir:v "100000155533" ] ;
fhir:display [ fhir:v "Annex II" ]
  ] [
fhir:code [ fhir:v "100000155534" ] ;
fhir:display [ fhir:v "Outer Packaging" ]
  ] [
fhir:code [ fhir:v "100000155535" ] ;
fhir:display [ fhir:v "Labelling" ]
  ] [
fhir:code [ fhir:v "100000155536" ] ;
fhir:display [ fhir:v "Immediate Packaging" ]
  ] [
fhir:code [ fhir:v "100000155537" ] ;
fhir:display [ fhir:v "Other Product Information" ]
  ] [
fhir:code [ fhir:v "100000155538" ] ;
fhir:display [ fhir:v "Package Leaflet" ]
  ] [
fhir:code [ fhir:v "100000155539" ] ;
fhir:display [ fhir:v "Combined File of all Documents" ]
  ] [
fhir:code [ fhir:v "100000155540" ] ;
fhir:display [ fhir:v "Mock ups" ]
  ] [
fhir:code [ fhir:v "100000155541" ] ;
fhir:display [ fhir:v "Appendix V" ]
  ] [
fhir:code [ fhir:v "200000017121" ] ;
fhir:display [ fhir:v "Package Leaflet and Labelling" ]
  ] [
fhir:code [ fhir:v "200000027914" ] ;
fhir:display [ fhir:v "Specimens" ]
  ] [
fhir:code [ fhir:v "200000027915" ] ;
fhir:display [ fhir:v "List of all authorised presentations (Annex A)" ]
  ] [
fhir:code [ fhir:v "200000027916" ] ;
fhir:display [ fhir:v "Restrictions posed by Member States (Annex 127a)" ]
  ] ) . #