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 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>
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<date value="2025-04-04T16:15:09+01:00"/>
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<code value="200000018808"/>
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value="Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)"/>
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<code value="200000018809"/>
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value="Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)"/>
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<code value="200000018810"/>
<display
value="Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)"/>
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<code value="200000018811"/>
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value="Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)"/>
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<code value="200000018813"/>
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value="Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)"/>
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<concept>
<code value="200000018814"/>
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value="Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)"/>
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<concept>
<code value="200000018815"/>
<display
value="Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)"/>
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