EMA Write PMS API Implementation Guide - Enrichments
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: Reason for Marketing Unavailability - TTL Representation

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 "200000018799"] ; # 
  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 200000018799</b></p><a name=\"200000018799\"> </a><a name=\"hc200000018799\"> </a><a name=\"200000018799-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/200000018799</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\">200000018808<a name=\"200000018799-200000018808\"> </a></td><td>Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018809<a name=\"200000018799-200000018809\"> </a></td><td>Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018810<a name=\"200000018799-200000018810\"> </a></td><td>Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018811<a name=\"200000018799-200000018811\"> </a></td><td>Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018812<a name=\"200000018799-200000018812\"> </a></td><td>Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018813<a name=\"200000018799-200000018813\"> </a></td><td>Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018814<a name=\"200000018799-200000018814\"> </a></td><td>Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000018815<a name=\"200000018799-200000018815\"> </a></td><td>Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)</td></tr></table></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/200000018799"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:name [ fhir:v "ReasonforMarketingUnavailabilityCs"] ; # 
  fhir:title [ fhir:v "Reason for Marketing Unavailability"] ; # 
  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 "Reason for Marketing Unavailability"] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "8"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "200000018808" ] ;
fhir:display [ fhir:v "Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018809" ] ;
fhir:display [ fhir:v "Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018810" ] ;
fhir:display [ fhir:v "Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018811" ] ;
fhir:display [ fhir:v "Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018812" ] ;
fhir:display [ fhir:v "Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018813" ] ;
fhir:display [ fhir:v "Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018814" ] ;
fhir:display [ fhir:v "Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)" ]
  ] [
fhir:code [ fhir:v "200000018815" ] ;
fhir:display [ fhir:v "Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)" ]
  ] ) . #