European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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: 04 Labelling Code Value Set - JSON Representation

Active as of 2025-04-02

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{
  "resourceType" : "ValueSet",
  "id" : "EUepilabellingcodesVs",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet EUepilabellingcodesVs</b></p><a name=\"EUepilabellingcodesVs\"> </a><a name=\"hcEUepilabellingcodesVs\"> </a><a name=\"EUepilabellingcodesVs-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-200000029659.html\"><code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-000000000000\">000000000000</a></td><td style=\"color: #cccccc\">Code for custom sub-sections (reserved)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029861\">200000029861</a></td><td style=\"color: #cccccc\">LABELLING</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029862\">200000029862</a></td><td style=\"color: #cccccc\">PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029863\">200000029863</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029864\">200000029864</a></td><td style=\"color: #cccccc\">2. STATEMENT OF ACTIVE SUBSTANCE(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029865\">200000029865</a></td><td style=\"color: #cccccc\">3. LIST OF EXCIPIENTS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029866\">200000029866</a></td><td style=\"color: #cccccc\">4. PHARMACEUTICAL FORM AND CONTENTS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029867\">200000029867</a></td><td style=\"color: #cccccc\">5. METHOD AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029868\">200000029868</a></td><td style=\"color: #cccccc\">6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029869\">200000029869</a></td><td style=\"color: #cccccc\">7. OTHER SPECIAL WARNING(S), IF NECESSARY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029870\">200000029870</a></td><td style=\"color: #cccccc\">8. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029871\">200000029871</a></td><td style=\"color: #cccccc\">9. SPECIAL STORAGE CONDITIONS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029872\">200000029872</a></td><td style=\"color: #cccccc\">10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029873\">200000029873</a></td><td style=\"color: #cccccc\">11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029874\">200000029874</a></td><td style=\"color: #cccccc\">12. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029875\">200000029875</a></td><td style=\"color: #cccccc\">13. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029876\">200000029876</a></td><td style=\"color: #cccccc\">14. GENERAL CLASSIFICATION FOR SUPPLY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029877\">200000029877</a></td><td style=\"color: #cccccc\">15. INSTRUCTIONS ON USE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029878\">200000029878</a></td><td style=\"color: #cccccc\">16. INFORMATION IN BRAILLE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029879\">200000029879</a></td><td style=\"color: #cccccc\">17. UNIQUE IDENTIFIER - 2D BARCODE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029880\">200000029880</a></td><td style=\"color: #cccccc\">18. UNIQUE IDENTIFIER - HUMAN READABLE DATA</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029881\">200000029881</a></td><td style=\"color: #cccccc\">MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029882\">200000029882</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029883\">200000029883</a></td><td style=\"color: #cccccc\">2. NAME OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029884\">200000029884</a></td><td style=\"color: #cccccc\">3. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029885\">200000029885</a></td><td style=\"color: #cccccc\">4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029886\">200000029886</a></td><td style=\"color: #cccccc\">5. OTHER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029887\">200000029887</a></td><td style=\"color: #cccccc\">MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029888\">200000029888</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029889\">200000029889</a></td><td style=\"color: #cccccc\">2. METHOD OF ADMINISTRATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029890\">200000029890</a></td><td style=\"color: #cccccc\">3. EXPIRY DATE</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029891\">200000029891</a></td><td style=\"color: #cccccc\">4. BATCH NUMBER[, DONATION AND PRODUCT CODES]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029892\">200000029892</a></td><td style=\"color: #cccccc\">5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029893\">200000029893</a></td><td style=\"color: #cccccc\">6. OTHER</td></tr></table></li></ul></div>"
  },
  "url" : "http://ema.europa.eu/fhir/ValueSet/EUepilabellingcodesVs",
  "version" : "1.0.0",
  "name" : "EUepilabellingcodesVs",
  "title" : "04 Labelling Code Value Set",
  "status" : "active",
  "experimental" : false,
  "date" : "2025-04-02T11:27:42+01:00",
  "publisher" : "European Medicines Agency",
  "contact" : [
    {
      "name" : "European Medicines Agency",
      "telecom" : [
        {
          "system" : "url",
          "value" : "https://ema.europa.eu/fhir"
        }
      ]
    },
    {
      "name" : "FHIR at EMA",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://ema.europa.eu/fhir"
        }
      ]
    }
  ],
  "description" : "List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service.",
  "compose" : {
    "include" : [
      {
        "system" : "http://ema.europa.eu/fhir/CodeSystem/200000029659",
        "concept" : [
          {
            "code" : "000000000000"
          },
          {
            "code" : "200000029861"
          },
          {
            "code" : "200000029862"
          },
          {
            "code" : "200000029863"
          },
          {
            "code" : "200000029864"
          },
          {
            "code" : "200000029865"
          },
          {
            "code" : "200000029866"
          },
          {
            "code" : "200000029867"
          },
          {
            "code" : "200000029868"
          },
          {
            "code" : "200000029869"
          },
          {
            "code" : "200000029870"
          },
          {
            "code" : "200000029871"
          },
          {
            "code" : "200000029872"
          },
          {
            "code" : "200000029873"
          },
          {
            "code" : "200000029874"
          },
          {
            "code" : "200000029875"
          },
          {
            "code" : "200000029876"
          },
          {
            "code" : "200000029877"
          },
          {
            "code" : "200000029878"
          },
          {
            "code" : "200000029879"
          },
          {
            "code" : "200000029880"
          },
          {
            "code" : "200000029881"
          },
          {
            "code" : "200000029882"
          },
          {
            "code" : "200000029883"
          },
          {
            "code" : "200000029884"
          },
          {
            "code" : "200000029885"
          },
          {
            "code" : "200000029886"
          },
          {
            "code" : "200000029887"
          },
          {
            "code" : "200000029888"
          },
          {
            "code" : "200000029889"
          },
          {
            "code" : "200000029890"
          },
          {
            "code" : "200000029891"
          },
          {
            "code" : "200000029892"
          },
          {
            "code" : "200000029893"
          }
        ]
      }
    ]
  }
}