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

: ePI List example 1 - XML Representation

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<List xmlns="http://hl7.org/fhir">
  <id value="36ce77ef-bb0b-ef11-a81c-000d3aaa7e62"/>
  <meta>
    <profile value="http://ema.europa.eu/fhir/StructureDefinition/EUEpiList"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">electronic Product Information (ePI) master document list</div>
  </text>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-authorization-type">
    <valueString value="CAP"/>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-marketing-authorisation-holder">
    <valueIdentifier>
      <system value="https://spor.ema.europa.eu/v1/organisations/"/>
      <value value="ORG-200036100"/>
    </valueIdentifier>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-marketing-authorisation-holder-display">
    <valueString value="SAMPLE-ORG (ORG-200036100)"/>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-medicine-domain">
    <valueCoding>
      <system value="http://ema.europa.eu/fhir/CodeSystem/100000000004"/>
      <code value="100000000012"/>
      <display value="Human use"/>
    </valueCoding>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-procedure-number">
    <valueIdentifier>
      <system value="http://ema.europa.eu/fhir/procedureNumber/"/>
      <value value="EPI/PR/001"/>
    </valueIdentifier>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-regulatory-agency">
    <valueIdentifier>
      <system value="https://spor.ema.europa.eu/v1/organisations/"/>
      <value value="ORG-100013412"/>
    </valueIdentifier>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-regulatory-agency-display">
    <valueString value="European Medicines Agency"/>
  </extension>
  <extension
             url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-version-number">
    <valueString value="1"/>
  </extension>
  <identifier>
    <system value="http://ema.europa.eu/fhir/epiId"/>
    <value value="EPI/24/81"/>
  </identifier>
  <status value="current"/>
  <mode value="working"/>
  <title value="May connectathon sample ePI"/>
  <code>
    <coding>
      <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531"/>
      <code value="100000155539"/>
      <display value="Combined File of all Documents"/>
    </coding>
  </code>
  <entry>
    <item>🔗 
      <reference value="Bundle/b99c95f8-bb0b-ef11-9f8a-000d3aa845fb"/>
      <display value="SUMMARY OF PRODUCT CHARACTERISTICS (English)"/>
    </item>
  </entry>
</List>