EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
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Active as of 2025-04-04 |
{
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"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>"
},
"url" : "http://spor.ema.europa.eu/v1/lists/200000018799",
"version" : "1.0.0",
"name" : "ReasonforMarketingUnavailabilityCs",
"title" : "Reason for Marketing Unavailability",
"status" : "active",
"experimental" : false,
"date" : "2025-04-04T16:15:09+01:00",
"publisher" : "EMA",
"contact" : [
{
"name" : "EMA",
"telecom" : [
{
"system" : "url",
"value" : "https://support.ema.europa.eu/esc"
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"description" : "Reason for Marketing Unavailability",
"caseSensitive" : true,
"content" : "complete",
"count" : 8,
"concept" : [
{
"code" : "200000018808",
"display" : "Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)"
},
{
"code" : "200000018809",
"display" : "Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)"
},
{
"code" : "200000018810",
"display" : "Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)"
},
{
"code" : "200000018811",
"display" : "Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)"
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{
"code" : "200000018812",
"display" : "Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC)"
},
{
"code" : "200000018813",
"display" : "Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)"
},
{
"code" : "200000018814",
"display" : "Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)"
},
{
"code" : "200000018815",
"display" : "Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)"
}
]
}