Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

: ePI Bundle Type 1 - DrugX Package Insert - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundlepackageleaflet75type1"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2018-06-23T08:38:00+02:00"/>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
  </meta>
  <identifier>
    <system value="https://www.gravitatehealth.eu/sid/doc"/>
    <value value="EU/1/01/001/001"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2018-06-23T08:38:00+02:00"/>
  <entry>
    <fullUrl value="urn:uuid:5467a2fd-2463-4ec7-a6bb-b7322000f867"/>
    <resource>
      <Composition>
        <id value="5467a2fd-2463-4ec7-a6bb-b7322000f867"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_5467a2fd-2463-4ec7-a6bb-b7322000f867"> </a><p><b>Generated Narrative: Composition</b><a name="5467a2fd-2463-4ec7-a6bb-b7322000f867"> </a><a name="hc5467a2fd-2463-4ec7-a6bb-b7322000f867"> </a></p><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">ResourceComposition &quot;5467a2fd-2463-4ec7-a6bb-b7322000f867&quot;  (Language &quot;en&quot;) </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu</code>/224b31c5-8e48-45c5-b616-29e902642578</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (example.org#100000155538)</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: See on this page: Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75</p><p><b>title</b>: Example of Type 1 ePI - DrugX (acetaminophen) 75 mg tablets</p></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu"/>
          <value value="224b31c5-8e48-45c5-b616-29e902642578"/>
        </identifier>
        <status value="final"/>
        <type>
          <coding>
            <system value="http://example.org"/>
            <code value="100000155538"/>
            <display value="Package Leaflet"/>
          </coding>
        </type>
        <subject>
          <identifier>
            <system value="http://example.org/sid/product"/>
            <value value="medicinalproduct75"/>
          </identifier>
        </subject>
        <date value="2022-02-16T13:28:17Z"/>
        <author>🔗 
          <reference
                     value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
        </author>
        <title
               value="Example of Type 1 ePI - DrugX (acetaminophen) 75 mg tablets"/>
        <section>
          <title value="B. Package Leaflet"/>
          <code>
            <coding>
              <system value="http://example.org"/>
              <code value="200000029894"/>
              <display value="PACKAGE LEAFLET"/>
            </coding>
          </code>
          <section>
            <title value="Package leaflet: Information for the user"/>
            <code>
              <text value="Package leaflet: Information for the user"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>DrugX 75 mg tablets</p><p>acetaminophen</p><b>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</b><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
            </text>
          </section>
          <section>
            <title value="What is in this leaflet"/>
            <code>
              <text value="What is in this leaflet"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>What DrugX is and what it is used for</li><li>What you need to know before you take DrugX</li><li>How to take DrugX</li><li>Possible side effects</li><li>How to store DrugX</li><li>Contents of the pack and other information</li></ul></div>
            </text>
          </section>
          <section>
            <title value="1. What DrugX is and what it is used for"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029895"/>
                <display value="1. What X is and what it is used for"/>
              </coding>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
          <section>
            <title value="2. What you need to know before you take DrugX"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029896"/>
                <display
                         value="2. What you need to know before you &lt;take&gt; &lt;use&gt; X"/>
              </coding>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
          <section>
            <title value="3. How to take DrugX"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029905"/>
                <display value="3. How to &lt;take&gt; &lt;use&gt; X"/>
              </coding>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
          <section>
            <title value="4. Possible side effects"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029910"/>
                <display value="4. Possible side effects"/>
              </coding>
              <text value="4. Possible side effects"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
          <section>
            <title value="5. How to store DrugX"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029913"/>
                <display value="5. How to store X"/>
              </coding>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
          <section>
            <title value="6. Contents of the pack and other information"/>
            <code>
              <coding>
                <system value="http://example.org"/>
                <code value="200000029914"/>
                <display
                         value="6. Contents of the pack and other information"/>
              </coding>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>
            </text>
          </section>
        </section>
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
    <resource>
      <Organization>
        <id value="d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75"> </a><p><b>Generated Narrative: Organization</b><a name="d71bf884-90eb-47f9-81b7-fa81ecec7e75"> </a><a name="hcd71bf884-90eb-47f9-81b7-fa81ecec7e75"> </a></p><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">ResourceOrganization &quot;d71bf884-90eb-47f9-81b7-fa81ecec7e75&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/sid/org</code>/ORG1 (use: official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (example.org#220000000034)</span></p><p><b>name</b>: acme inc</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>54, Yonge Street, Paris, France(work)</td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="http://example.org/sid/org"/>
          <value value="ORG1"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system value="http://example.org"/>
            <code value="220000000034"/>
            <display value="Marketing authorisation holder"/>
          </coding>
        </type>
        <name value="acme inc"/>
        <contact>
          <address>
            <use value="work"/>
            <type value="physical"/>
            <text value="54, Yonge Street, Paris, France"/>
            <line value="54, Yonge Street"/>
            <city value="Paris"/>
            <country value="FR"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
</Bundle>