EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Active as of 2025-04-04 |
@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 "100000160406"] ; #
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 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>"^^rdf:XMLLiteral
] ; #
fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000160406"^^xsd:anyURI] ; #
fhir:version [ fhir:v "1.0.0"] ; #
fhir:name [ fhir:v "ManufacturingActivityCs"] ; #
fhir:title [ fhir:v "Manufacturing Activity Value Set"] ; #
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 "Manufacturing Activity Value Set"] ; #
fhir:caseSensitive [ fhir:v true] ; #
fhir:content [ fhir:v "complete"] ; #
fhir:count [ fhir:v "50"^^xsd:nonNegativeInteger] ; #
fhir:concept ( [
fhir:code [ fhir:v "100000160407" ] ;
fhir:display [ fhir:v "Manufacturer responsible for batch certification" ]
] [
fhir:code [ fhir:v "100000160408" ] ;
fhir:display [ fhir:v "Quality control testing of medicinal product" ]
] [
fhir:code [ fhir:v "100000160409" ] ;
fhir:display [ fhir:v "Microbiological testing: sterility" ]
] [
fhir:code [ fhir:v "100000160410" ] ;
fhir:display [ fhir:v "Microbiological testing: non-sterility" ]
] [
fhir:code [ fhir:v "100000160411" ] ;
fhir:display [ fhir:v "Chemical/Physical testing" ]
] [
fhir:code [ fhir:v "100000160412" ] ;
fhir:display [ fhir:v "Biological testing" ]
] [
fhir:code [ fhir:v "100000160413" ] ;
fhir:display [ fhir:v "Processing operations for the medicinal product" ]
] [
fhir:code [ fhir:v "100000160415" ] ;
fhir:display [ fhir:v "Manufacturer of solvent / diluent" ]
] [
fhir:code [ fhir:v "100000160448" ] ;
fhir:display [ fhir:v "Quality control testing of active substance" ]
] [
fhir:code [ fhir:v "100000160449" ] ;
fhir:display [ fhir:v "Microbiological testing: sterility" ]
] [
fhir:code [ fhir:v "100000160450" ] ;
fhir:display [ fhir:v "Microbiological testing: non-sterility" ]
] [
fhir:code [ fhir:v "100000160451" ] ;
fhir:display [ fhir:v "Chemical/Physical testing" ]
] [
fhir:code [ fhir:v "100000160452" ] ;
fhir:display [ fhir:v "Biological testing" ]
] [
fhir:code [ fhir:v "100000160453" ] ;
fhir:display [ fhir:v "Manufacturer of active substance intermediate" ]
] [
fhir:code [ fhir:v "100000160454" ] ;
fhir:display [ fhir:v "Packaging of active substance" ]
] [
fhir:code [ fhir:v "100000160455" ] ;
fhir:display [ fhir:v "Storage and/or distribution of active substance" ]
] [
fhir:code [ fhir:v "100000160456" ] ;
fhir:display [ fhir:v "Sterilisation" ]
] [
fhir:code [ fhir:v "100000160457" ] ;
fhir:display [ fhir:v "Filtration" ]
] [
fhir:code [ fhir:v "100000160458" ] ;
fhir:display [ fhir:v "Dry heat" ]
] [
fhir:code [ fhir:v "100000160459" ] ;
fhir:display [ fhir:v "Moist heat" ]
] [
fhir:code [ fhir:v "100000160460" ] ;
fhir:display [ fhir:v "Chemical" ]
] [
fhir:code [ fhir:v "100000160461" ] ;
fhir:display [ fhir:v "Gamma irradiation" ]
] [
fhir:code [ fhir:v "100000160462" ] ;
fhir:display [ fhir:v "Electron beam" ]
] [
fhir:code [ fhir:v "100000160463" ] ;
fhir:display [ fhir:v "Primary packaging" ]
] [
fhir:code [ fhir:v "100000160464" ] ;
fhir:display [ fhir:v "Secondary packaging" ]
] [
fhir:code [ fhir:v "100000160465" ] ;
fhir:display [ fhir:v "Physical Importation" ]
] [
fhir:code [ fhir:v "100000160466" ] ;
fhir:display [ fhir:v "Storage and/or distribution of medicinal product" ]
] [
fhir:code [ fhir:v "100000160467" ] ;
fhir:display [ fhir:v "Manufacturer of active substance" ]
] [
fhir:code [ fhir:v "100000160476" ] ;
fhir:display [ fhir:v "Preparation of Working Cell Bank" ]
] [
fhir:code [ fhir:v "100000160477" ] ;
fhir:display [ fhir:v "Storage of Master Cell Bank and/or Working Cell Bank" ]
] [
fhir:code [ fhir:v "100000160478" ] ;
fhir:display [ fhir:v "Bioequivalence Contract Research Organisation (CRO)" ]
] [
fhir:code [ fhir:v "100000160479" ] ;
fhir:display [ fhir:v "Manufacturer of ancillary medicinal product" ]
] [
fhir:code [ fhir:v "100000160480" ] ;
fhir:display [ fhir:v "Manufacturer of medical device" ]
] [
fhir:code [ fhir:v "100000160481" ] ;
fhir:display [ fhir:v "Manufacturer of ancillary substance used in medical device" ]
] [
fhir:code [ fhir:v "100000160482" ] ;
fhir:display [ fhir:v "Official Medicine Control Laboratory (OMCL)" ]
] [
fhir:code [ fhir:v "100000160483" ] ;
fhir:display [ fhir:v "Notified Body of medical device" ]
] [
fhir:code [ fhir:v "100000163618" ] ;
fhir:display [ fhir:v "Processing of non-sterile medicinal product" ]
] [
fhir:code [ fhir:v "100000163709" ] ;
fhir:display [ fhir:v "Processing of sterile medicinal product - aseptically prepared" ]
] [
fhir:code [ fhir:v "100000163713" ] ;
fhir:display [ fhir:v "Manufacturer of active substance intermediate by chemical synthesis" ]
] [
fhir:code [ fhir:v "100000163714" ] ;
fhir:display [ fhir:v "Manufacturer of active substance intermediate using biological processes" ]
] [
fhir:code [ fhir:v "100000163715" ] ;
fhir:display [ fhir:v "Active substance intermediate physical processing" ]
] [
fhir:code [ fhir:v "100000163716" ] ;
fhir:display [ fhir:v "Primary Packaging of active substance" ]
] [
fhir:code [ fhir:v "100000163717" ] ;
fhir:display [ fhir:v "Secondary Packaging of active substance" ]
] [
fhir:code [ fhir:v "100000163737" ] ;
fhir:display [ fhir:v "Processing of sterile medicinal product - terminally sterilised" ]
] [
fhir:code [ fhir:v "100000163843" ] ;
fhir:display [ fhir:v "Manufacturer of active substance by chemical synthesis" ]
] [
fhir:code [ fhir:v "100000163844" ] ;
fhir:display [ fhir:v "Extraction of active substance from natural sources" ]
] [
fhir:code [ fhir:v "100000163845" ] ;
fhir:display [ fhir:v "Manufacturer of active substance using biological processes" ]
] [
fhir:code [ fhir:v "100000163846" ] ;
fhir:display [ fhir:v "Active substance physical processing" ]
] [
fhir:code [ fhir:v "200000023301" ] ;
fhir:display [ fhir:v "Importation of intermediate which undergoes further processing" ]
] [
fhir:code [ fhir:v "200000028596" ] ;
fhir:display [ fhir:v "Manufacturer of active substance starting material using biological processes" ]
] ) . #
IG © 2025 EMA. Package emavar#1.0.0 based on FHIR 5.0.0. Generated 2025-04-04
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