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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: 03 Annex II Code Value Set - XML Representation

Active as of 2025-04-02

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="EUepiannexqrdcodesVs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet EUepiannexqrdcodesVs</b></p><a name="EUepiannexqrdcodesVs"> </a><a name="hcEUepiannexqrdcodesVs"> </a><a name="EUepiannexqrdcodesVs-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#200000029659-200000029850">200000029850</a></td><td style="color: #cccccc">ANNEX II</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029851">200000029851</a></td><td style="color: #cccccc">A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029852">200000029852</a></td><td style="color: #cccccc">B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029853">200000029853</a></td><td style="color: #cccccc">Official batch release</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029854">200000029854</a></td><td style="color: #cccccc">C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029855">200000029855</a></td><td style="color: #cccccc">Periodic safety update reports (PSURs)</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029856">200000029856</a></td><td style="color: #cccccc">D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029857">200000029857</a></td><td style="color: #cccccc">Risk management plan (RMP)</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029858">200000029858</a></td><td style="color: #cccccc">Additional risk minimisation measures</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029859">200000029859</a></td><td style="color: #cccccc">Obligation to conduct post-authorisation measures</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029860">200000029860</a></td><td style="color: #cccccc">E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES</td></tr></table></li></ul></div>
  </text>
  <url value="http://ema.europa.eu/fhir/ValueSet/EUepiannexqrdcodesVs"/>
  <version value="1.0.0"/>
  <name value="EUepiannexqrdcodesVs"/>
  <title value="03 Annex II 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 Annex II 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="200000029850"/>
      </concept>
      <concept>
        <code value="200000029851"/>
      </concept>
      <concept>
        <code value="200000029852"/>
      </concept>
      <concept>
        <code value="200000029853"/>
      </concept>
      <concept>
        <code value="200000029854"/>
      </concept>
      <concept>
        <code value="200000029855"/>
      </concept>
      <concept>
        <code value="200000029856"/>
      </concept>
      <concept>
        <code value="200000029857"/>
      </concept>
      <concept>
        <code value="200000029858"/>
      </concept>
      <concept>
        <code value="200000029859"/>
      </concept>
      <concept>
        <code value="200000029860"/>
      </concept>
    </include>
  </compose>
</ValueSet>