EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
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Active as of 2025-04-04 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="100000160406"/>
<meta>
<versionId value="5.0.0"/>
<lastUpdated value="2023-08-03T11:35:00.198Z"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 100000160406</b></p><a name="100000160406"> </a><a name="hc100000160406"> </a><a name="100000160406-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/100000160406</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">100000160407<a name="100000160406-100000160407"> </a></td><td>Manufacturer responsible for batch certification</td></tr><tr><td style="white-space:nowrap">100000160408<a name="100000160406-100000160408"> </a></td><td>Quality control testing of medicinal product</td></tr><tr><td style="white-space:nowrap">100000160409<a name="100000160406-100000160409"> </a></td><td>Microbiological testing: sterility</td></tr><tr><td style="white-space:nowrap">100000160410<a name="100000160406-100000160410"> </a></td><td>Microbiological testing: non-sterility</td></tr><tr><td style="white-space:nowrap">100000160411<a name="100000160406-100000160411"> </a></td><td>Chemical/Physical testing</td></tr><tr><td style="white-space:nowrap">100000160412<a name="100000160406-100000160412"> </a></td><td>Biological testing</td></tr><tr><td style="white-space:nowrap">100000160413<a name="100000160406-100000160413"> </a></td><td>Processing operations for the medicinal product</td></tr><tr><td style="white-space:nowrap">100000160415<a name="100000160406-100000160415"> </a></td><td>Manufacturer of solvent / diluent</td></tr><tr><td style="white-space:nowrap">100000160448<a name="100000160406-100000160448"> </a></td><td>Quality control testing of active substance</td></tr><tr><td style="white-space:nowrap">100000160449<a name="100000160406-100000160449"> </a></td><td>Microbiological testing: sterility</td></tr><tr><td style="white-space:nowrap">100000160450<a name="100000160406-100000160450"> </a></td><td>Microbiological testing: non-sterility</td></tr><tr><td style="white-space:nowrap">100000160451<a name="100000160406-100000160451"> </a></td><td>Chemical/Physical testing</td></tr><tr><td style="white-space:nowrap">100000160452<a name="100000160406-100000160452"> </a></td><td>Biological testing</td></tr><tr><td style="white-space:nowrap">100000160453<a name="100000160406-100000160453"> </a></td><td>Manufacturer of active substance intermediate</td></tr><tr><td style="white-space:nowrap">100000160454<a name="100000160406-100000160454"> </a></td><td>Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000160455<a name="100000160406-100000160455"> </a></td><td>Storage and/or distribution of active substance</td></tr><tr><td style="white-space:nowrap">100000160456<a name="100000160406-100000160456"> </a></td><td>Sterilisation</td></tr><tr><td style="white-space:nowrap">100000160457<a name="100000160406-100000160457"> </a></td><td>Filtration</td></tr><tr><td style="white-space:nowrap">100000160458<a name="100000160406-100000160458"> </a></td><td>Dry heat</td></tr><tr><td style="white-space:nowrap">100000160459<a name="100000160406-100000160459"> </a></td><td>Moist heat</td></tr><tr><td style="white-space:nowrap">100000160460<a name="100000160406-100000160460"> </a></td><td>Chemical</td></tr><tr><td style="white-space:nowrap">100000160461<a name="100000160406-100000160461"> </a></td><td>Gamma irradiation</td></tr><tr><td style="white-space:nowrap">100000160462<a name="100000160406-100000160462"> </a></td><td>Electron beam</td></tr><tr><td style="white-space:nowrap">100000160463<a name="100000160406-100000160463"> </a></td><td>Primary packaging</td></tr><tr><td style="white-space:nowrap">100000160464<a name="100000160406-100000160464"> </a></td><td>Secondary packaging</td></tr><tr><td style="white-space:nowrap">100000160465<a name="100000160406-100000160465"> </a></td><td>Physical Importation</td></tr><tr><td style="white-space:nowrap">100000160466<a name="100000160406-100000160466"> </a></td><td>Storage and/or distribution of medicinal product</td></tr><tr><td style="white-space:nowrap">100000160467<a name="100000160406-100000160467"> </a></td><td>Manufacturer of active substance</td></tr><tr><td style="white-space:nowrap">100000160476<a name="100000160406-100000160476"> </a></td><td>Preparation of Working Cell Bank</td></tr><tr><td style="white-space:nowrap">100000160477<a name="100000160406-100000160477"> </a></td><td>Storage of Master Cell Bank and/or Working Cell Bank</td></tr><tr><td style="white-space:nowrap">100000160478<a name="100000160406-100000160478"> </a></td><td>Bioequivalence Contract Research Organisation (CRO)</td></tr><tr><td style="white-space:nowrap">100000160479<a name="100000160406-100000160479"> </a></td><td>Manufacturer of ancillary medicinal product</td></tr><tr><td style="white-space:nowrap">100000160480<a name="100000160406-100000160480"> </a></td><td>Manufacturer of medical device</td></tr><tr><td style="white-space:nowrap">100000160481<a name="100000160406-100000160481"> </a></td><td>Manufacturer of ancillary substance used in medical device</td></tr><tr><td style="white-space:nowrap">100000160482<a name="100000160406-100000160482"> </a></td><td>Official Medicine Control Laboratory (OMCL)</td></tr><tr><td style="white-space:nowrap">100000160483<a name="100000160406-100000160483"> </a></td><td>Notified Body of medical device</td></tr><tr><td style="white-space:nowrap">100000163618<a name="100000160406-100000163618"> </a></td><td>Processing of non-sterile medicinal product</td></tr><tr><td style="white-space:nowrap">100000163709<a name="100000160406-100000163709"> </a></td><td>Processing of sterile medicinal product - aseptically prepared</td></tr><tr><td style="white-space:nowrap">100000163713<a name="100000160406-100000163713"> </a></td><td>Manufacturer of active substance intermediate by chemical synthesis</td></tr><tr><td style="white-space:nowrap">100000163714<a name="100000160406-100000163714"> </a></td><td>Manufacturer of active substance intermediate using biological processes</td></tr><tr><td style="white-space:nowrap">100000163715<a name="100000160406-100000163715"> </a></td><td>Active substance intermediate physical processing</td></tr><tr><td style="white-space:nowrap">100000163716<a name="100000160406-100000163716"> </a></td><td>Primary Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000163717<a name="100000160406-100000163717"> </a></td><td>Secondary Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000163737<a name="100000160406-100000163737"> </a></td><td>Processing of sterile medicinal product - terminally sterilised</td></tr><tr><td style="white-space:nowrap">100000163843<a name="100000160406-100000163843"> </a></td><td>Manufacturer of active substance by chemical synthesis</td></tr><tr><td style="white-space:nowrap">100000163844<a name="100000160406-100000163844"> </a></td><td>Extraction of active substance from natural sources</td></tr><tr><td style="white-space:nowrap">100000163845<a name="100000160406-100000163845"> </a></td><td>Manufacturer of active substance using biological processes</td></tr><tr><td style="white-space:nowrap">100000163846<a name="100000160406-100000163846"> </a></td><td>Active substance physical processing</td></tr><tr><td style="white-space:nowrap">200000023301<a name="100000160406-200000023301"> </a></td><td>Importation of intermediate which undergoes further processing</td></tr><tr><td style="white-space:nowrap">200000028596<a name="100000160406-200000028596"> </a></td><td>Manufacturer of active substance starting material using biological processes</td></tr></table></div>
</text>
<url value="http://spor.ema.europa.eu/v1/lists/100000160406"/>
<version value="1.0.0"/>
<name value="ManufacturingActivityCs"/>
<title value="Manufacturing Activity Value Set"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-04-04T16:15:09+01:00"/>
<publisher value="EMA"/>
<contact>
<name value="EMA"/>
<telecom>
<system value="url"/>
<value value="https://support.ema.europa.eu/esc"/>
</telecom>
</contact>
<description value="Manufacturing Activity Value Set"/>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="50"/>
<concept>
<code value="100000160407"/>
<display value="Manufacturer responsible for batch certification"/>
</concept>
<concept>
<code value="100000160408"/>
<display value="Quality control testing of medicinal product"/>
</concept>
<concept>
<code value="100000160409"/>
<display value="Microbiological testing: sterility"/>
</concept>
<concept>
<code value="100000160410"/>
<display value="Microbiological testing: non-sterility"/>
</concept>
<concept>
<code value="100000160411"/>
<display value="Chemical/Physical testing"/>
</concept>
<concept>
<code value="100000160412"/>
<display value="Biological testing"/>
</concept>
<concept>
<code value="100000160413"/>
<display value="Processing operations for the medicinal product"/>
</concept>
<concept>
<code value="100000160415"/>
<display value="Manufacturer of solvent / diluent"/>
</concept>
<concept>
<code value="100000160448"/>
<display value="Quality control testing of active substance"/>
</concept>
<concept>
<code value="100000160449"/>
<display value="Microbiological testing: sterility"/>
</concept>
<concept>
<code value="100000160450"/>
<display value="Microbiological testing: non-sterility"/>
</concept>
<concept>
<code value="100000160451"/>
<display value="Chemical/Physical testing"/>
</concept>
<concept>
<code value="100000160452"/>
<display value="Biological testing"/>
</concept>
<concept>
<code value="100000160453"/>
<display value="Manufacturer of active substance intermediate"/>
</concept>
<concept>
<code value="100000160454"/>
<display value="Packaging of active substance"/>
</concept>
<concept>
<code value="100000160455"/>
<display value="Storage and/or distribution of active substance"/>
</concept>
<concept>
<code value="100000160456"/>
<display value="Sterilisation"/>
</concept>
<concept>
<code value="100000160457"/>
<display value="Filtration"/>
</concept>
<concept>
<code value="100000160458"/>
<display value="Dry heat"/>
</concept>
<concept>
<code value="100000160459"/>
<display value="Moist heat"/>
</concept>
<concept>
<code value="100000160460"/>
<display value="Chemical"/>
</concept>
<concept>
<code value="100000160461"/>
<display value="Gamma irradiation"/>
</concept>
<concept>
<code value="100000160462"/>
<display value="Electron beam"/>
</concept>
<concept>
<code value="100000160463"/>
<display value="Primary packaging"/>
</concept>
<concept>
<code value="100000160464"/>
<display value="Secondary packaging"/>
</concept>
<concept>
<code value="100000160465"/>
<display value="Physical Importation"/>
</concept>
<concept>
<code value="100000160466"/>
<display value="Storage and/or distribution of medicinal product"/>
</concept>
<concept>
<code value="100000160467"/>
<display value="Manufacturer of active substance"/>
</concept>
<concept>
<code value="100000160476"/>
<display value="Preparation of Working Cell Bank"/>
</concept>
<concept>
<code value="100000160477"/>
<display value="Storage of Master Cell Bank and/or Working Cell Bank"/>
</concept>
<concept>
<code value="100000160478"/>
<display value="Bioequivalence Contract Research Organisation (CRO)"/>
</concept>
<concept>
<code value="100000160479"/>
<display value="Manufacturer of ancillary medicinal product"/>
</concept>
<concept>
<code value="100000160480"/>
<display value="Manufacturer of medical device"/>
</concept>
<concept>
<code value="100000160481"/>
<display
value="Manufacturer of ancillary substance used in medical device"/>
</concept>
<concept>
<code value="100000160482"/>
<display value="Official Medicine Control Laboratory (OMCL)"/>
</concept>
<concept>
<code value="100000160483"/>
<display value="Notified Body of medical device"/>
</concept>
<concept>
<code value="100000163618"/>
<display value="Processing of non-sterile medicinal product"/>
</concept>
<concept>
<code value="100000163709"/>
<display
value="Processing of sterile medicinal product - aseptically prepared"/>
</concept>
<concept>
<code value="100000163713"/>
<display
value="Manufacturer of active substance intermediate by chemical synthesis"/>
</concept>
<concept>
<code value="100000163714"/>
<display
value="Manufacturer of active substance intermediate using biological processes"/>
</concept>
<concept>
<code value="100000163715"/>
<display value="Active substance intermediate physical processing"/>
</concept>
<concept>
<code value="100000163716"/>
<display value="Primary Packaging of active substance"/>
</concept>
<concept>
<code value="100000163717"/>
<display value="Secondary Packaging of active substance"/>
</concept>
<concept>
<code value="100000163737"/>
<display
value="Processing of sterile medicinal product - terminally sterilised"/>
</concept>
<concept>
<code value="100000163843"/>
<display value="Manufacturer of active substance by chemical synthesis"/>
</concept>
<concept>
<code value="100000163844"/>
<display value="Extraction of active substance from natural sources"/>
</concept>
<concept>
<code value="100000163845"/>
<display
value="Manufacturer of active substance using biological processes"/>
</concept>
<concept>
<code value="100000163846"/>
<display value="Active substance physical processing"/>
</concept>
<concept>
<code value="200000023301"/>
<display
value="Importation of intermediate which undergoes further processing"/>
</concept>
<concept>
<code value="200000028596"/>
<display
value="Manufacturer of active substance starting material using biological processes"/>
</concept>
</CodeSystem>