EMA Write PMS API Implementation Guide - Enrichments
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: Manufacturing Activity Value Set - JSON Representation

Active as of 2025-04-04

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{
  "resourceType" : "CodeSystem",
  "id" : "100000160406",
  "meta" : {
    "versionId" : "5.0.0",
    "lastUpdated" : "2023-08-03T11:35:00.198Z"
  },
  "text" : {
    "status" : "generated",
    "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>"
  },
  "url" : "http://spor.ema.europa.eu/v1/lists/100000160406",
  "version" : "1.0.0",
  "name" : "ManufacturingActivityCs",
  "title" : "Manufacturing Activity Value Set",
  "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"
        }
      ]
    }
  ],
  "description" : "Manufacturing Activity Value Set",
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 50,
  "concept" : [
    {
      "code" : "100000160407",
      "display" : "Manufacturer responsible for batch certification"
    },
    {
      "code" : "100000160408",
      "display" : "Quality control testing of medicinal product"
    },
    {
      "code" : "100000160409",
      "display" : "Microbiological testing: sterility"
    },
    {
      "code" : "100000160410",
      "display" : "Microbiological testing: non-sterility"
    },
    {
      "code" : "100000160411",
      "display" : "Chemical/Physical testing"
    },
    {
      "code" : "100000160412",
      "display" : "Biological testing"
    },
    {
      "code" : "100000160413",
      "display" : "Processing operations for the medicinal product"
    },
    {
      "code" : "100000160415",
      "display" : "Manufacturer of solvent / diluent"
    },
    {
      "code" : "100000160448",
      "display" : "Quality control testing of active substance"
    },
    {
      "code" : "100000160449",
      "display" : "Microbiological testing: sterility"
    },
    {
      "code" : "100000160450",
      "display" : "Microbiological testing: non-sterility"
    },
    {
      "code" : "100000160451",
      "display" : "Chemical/Physical testing"
    },
    {
      "code" : "100000160452",
      "display" : "Biological testing"
    },
    {
      "code" : "100000160453",
      "display" : "Manufacturer of active substance intermediate"
    },
    {
      "code" : "100000160454",
      "display" : "Packaging of active substance"
    },
    {
      "code" : "100000160455",
      "display" : "Storage and/or distribution of active substance"
    },
    {
      "code" : "100000160456",
      "display" : "Sterilisation"
    },
    {
      "code" : "100000160457",
      "display" : "Filtration"
    },
    {
      "code" : "100000160458",
      "display" : "Dry heat"
    },
    {
      "code" : "100000160459",
      "display" : "Moist heat"
    },
    {
      "code" : "100000160460",
      "display" : "Chemical"
    },
    {
      "code" : "100000160461",
      "display" : "Gamma irradiation"
    },
    {
      "code" : "100000160462",
      "display" : "Electron beam"
    },
    {
      "code" : "100000160463",
      "display" : "Primary packaging"
    },
    {
      "code" : "100000160464",
      "display" : "Secondary packaging"
    },
    {
      "code" : "100000160465",
      "display" : "Physical Importation"
    },
    {
      "code" : "100000160466",
      "display" : "Storage and/or distribution of medicinal product"
    },
    {
      "code" : "100000160467",
      "display" : "Manufacturer of active substance"
    },
    {
      "code" : "100000160476",
      "display" : "Preparation of Working Cell Bank"
    },
    {
      "code" : "100000160477",
      "display" : "Storage of Master Cell Bank and/or Working Cell Bank"
    },
    {
      "code" : "100000160478",
      "display" : "Bioequivalence Contract Research Organisation (CRO)"
    },
    {
      "code" : "100000160479",
      "display" : "Manufacturer of ancillary medicinal product"
    },
    {
      "code" : "100000160480",
      "display" : "Manufacturer of medical device"
    },
    {
      "code" : "100000160481",
      "display" : "Manufacturer of ancillary substance used in medical device"
    },
    {
      "code" : "100000160482",
      "display" : "Official Medicine Control Laboratory (OMCL)"
    },
    {
      "code" : "100000160483",
      "display" : "Notified Body of medical device"
    },
    {
      "code" : "100000163618",
      "display" : "Processing of non-sterile medicinal product"
    },
    {
      "code" : "100000163709",
      "display" : "Processing of sterile medicinal product - aseptically prepared"
    },
    {
      "code" : "100000163713",
      "display" : "Manufacturer of active substance intermediate by chemical synthesis"
    },
    {
      "code" : "100000163714",
      "display" : "Manufacturer of active substance intermediate using biological processes"
    },
    {
      "code" : "100000163715",
      "display" : "Active substance intermediate physical processing"
    },
    {
      "code" : "100000163716",
      "display" : "Primary Packaging of active substance"
    },
    {
      "code" : "100000163717",
      "display" : "Secondary Packaging of active substance"
    },
    {
      "code" : "100000163737",
      "display" : "Processing of sterile medicinal product - terminally sterilised"
    },
    {
      "code" : "100000163843",
      "display" : "Manufacturer of active substance by chemical synthesis"
    },
    {
      "code" : "100000163844",
      "display" : "Extraction of active substance from natural sources"
    },
    {
      "code" : "100000163845",
      "display" : "Manufacturer of active substance using biological processes"
    },
    {
      "code" : "100000163846",
      "display" : "Active substance physical processing"
    },
    {
      "code" : "200000023301",
      "display" : "Importation of intermediate which undergoes further processing"
    },
    {
      "code" : "200000028596",
      "display" : "Manufacturer of active substance starting material using biological processes"
    }
  ]
}