European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build

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

: 04 Labelling Code Value Set - XML Representation

Active as of 2025-04-02

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="EUepilabellingcodesVs"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <url value="http://ema.europa.eu/fhir/ValueSet/EUepilabellingcodesVs"/>
  <version value="1.0.0"/>
  <name value="EUepilabellingcodesVs"/>
  <title value="04 Labelling Code Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-02T11:27:42+01:00"/>
  <publisher value="European Medicines Agency"/>
  <contact>
    <name value="European Medicines Agency"/>
    <telecom>
      <system value="url"/>
      <value value="https://ema.europa.eu/fhir"/>
    </telecom>
  </contact>
  <contact>
    <name value="FHIR at EMA"/>
    <telecom>
      <system value="url"/>
      <value value="http://ema.europa.eu/fhir"/>
    </telecom>
  </contact>
  <description
               value="List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service."/>
  <compose>
    <include>
      <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659"/>
      <concept>
        <code value="000000000000"/>
      </concept>
      <concept>
        <code value="200000029861"/>
      </concept>
      <concept>
        <code value="200000029862"/>
      </concept>
      <concept>
        <code value="200000029863"/>
      </concept>
      <concept>
        <code value="200000029864"/>
      </concept>
      <concept>
        <code value="200000029865"/>
      </concept>
      <concept>
        <code value="200000029866"/>
      </concept>
      <concept>
        <code value="200000029867"/>
      </concept>
      <concept>
        <code value="200000029868"/>
      </concept>
      <concept>
        <code value="200000029869"/>
      </concept>
      <concept>
        <code value="200000029870"/>
      </concept>
      <concept>
        <code value="200000029871"/>
      </concept>
      <concept>
        <code value="200000029872"/>
      </concept>
      <concept>
        <code value="200000029873"/>
      </concept>
      <concept>
        <code value="200000029874"/>
      </concept>
      <concept>
        <code value="200000029875"/>
      </concept>
      <concept>
        <code value="200000029876"/>
      </concept>
      <concept>
        <code value="200000029877"/>
      </concept>
      <concept>
        <code value="200000029878"/>
      </concept>
      <concept>
        <code value="200000029879"/>
      </concept>
      <concept>
        <code value="200000029880"/>
      </concept>
      <concept>
        <code value="200000029881"/>
      </concept>
      <concept>
        <code value="200000029882"/>
      </concept>
      <concept>
        <code value="200000029883"/>
      </concept>
      <concept>
        <code value="200000029884"/>
      </concept>
      <concept>
        <code value="200000029885"/>
      </concept>
      <concept>
        <code value="200000029886"/>
      </concept>
      <concept>
        <code value="200000029887"/>
      </concept>
      <concept>
        <code value="200000029888"/>
      </concept>
      <concept>
        <code value="200000029889"/>
      </concept>
      <concept>
        <code value="200000029890"/>
      </concept>
      <concept>
        <code value="200000029891"/>
      </concept>
      <concept>
        <code value="200000029892"/>
      </concept>
      <concept>
        <code value="200000029893"/>
      </concept>
    </include>
  </compose>
</ValueSet>