European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: Annex II Codes - TTL Representation

Active as of 2026-08-26

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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 -------------------------------------------------------------------

<http://hl7.org/fhir/ValueSet/EUepiannexqrdcodesVs> a fhir:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "EUepiannexqrdcodesVs"] ; # 
  fhir:text [
     fhir:status [ fhir:v "generated" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet EUepiannexqrdcodesVs</b></p><a name=\"EUepiannexqrdcodesVs\"> </a><a name=\"hcEUepiannexqrdcodesVs\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-200000029659.html\"><code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code></a><span title=\"Version is not explicitly stated, which means it is fixed to the version provided in this specification\"> version ?1.0.0</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-000000000000\">000000000000</a></td><td style=\"color: #cccccc\">Code for custom sub-sections (reserved)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029850\">200000029850</a></td><td style=\"color: #cccccc\">ANNEX II</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029851\">200000029851</a></td><td style=\"color: #cccccc\">A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029852\">200000029852</a></td><td style=\"color: #cccccc\">B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029853\">200000029853</a></td><td style=\"color: #cccccc\">Official batch release</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029854\">200000029854</a></td><td style=\"color: #cccccc\">C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029855\">200000029855</a></td><td style=\"color: #cccccc\">Periodic safety update reports (PSURs)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029856\">200000029856</a></td><td style=\"color: #cccccc\">D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029857\">200000029857</a></td><td style=\"color: #cccccc\">Risk management plan (RMP)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029858\">200000029858</a></td><td style=\"color: #cccccc\">Additional risk minimisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029859\">200000029859</a></td><td style=\"color: #cccccc\">Obligation to conduct post-authorisation measures</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029860\">200000029860</a></td><td style=\"color: #cccccc\">E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td></tr></table></li></ul></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [ fhir:v "http://ema.europa.eu/fhir/ValueSet/EUepiannexqrdcodesVs"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:name [ fhir:v "EUepiannexqrdcodesVs"] ; # 
  fhir:title [ fhir:v "Annex II Codes"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-08-26T09:34:02+01:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "European Medicines Agency"] ; # 
  fhir:contact ( [
     fhir:name [ fhir:v "European Medicines Agency" ] ;
     fhir:telecom ( [
       fhir:system [ fhir:v "url" ] ;
       fhir:value [ fhir:v "https://ema.europa.eu/fhir" ]
     ] )
  ] [
     fhir:name [ fhir:v "FHIR at EMA" ] ;
     fhir:telecom ( [
       fhir:system [ fhir:v "url" ] ;
       fhir:value [ fhir:v "http://ema.europa.eu/fhir" ]
     ] )
  ] ) ; # 
  fhir:description [ fhir:v "List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service."] ; # 
  fhir:compose [
     fhir:include ( [
       fhir:system [ fhir:v "http://ema.europa.eu/fhir/CodeSystem/200000029659"^^xsd:anyURI ] ;
       fhir:concept ( [
         fhir:code [ fhir:v "000000000000" ]
       ] [
         fhir:code [ fhir:v "200000029850" ]
       ] [
         fhir:code [ fhir:v "200000029851" ]
       ] [
         fhir:code [ fhir:v "200000029852" ]
       ] [
         fhir:code [ fhir:v "200000029853" ]
       ] [
         fhir:code [ fhir:v "200000029854" ]
       ] [
         fhir:code [ fhir:v "200000029855" ]
       ] [
         fhir:code [ fhir:v "200000029856" ]
       ] [
         fhir:code [ fhir:v "200000029857" ]
       ] [
         fhir:code [ fhir:v "200000029858" ]
       ] [
         fhir:code [ fhir:v "200000029859" ]
       ] [
         fhir:code [ fhir:v "200000029860" ]
       ] )
     ] )
  ] . #