Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions
<?xml version="1.0" encoding="UTF-8"?>
<!-- FICTIONAL EXAMPLE for the RWI-pharma IG. Abbreviated FHIR ePI document Bundle (product information for WonderDrug 50 mg film-coated tablets),
showing only the sections changed by this variation. Section and document type codes use a placeholder code system. -->
<Bundle xmlns="http://hl7.org/fhir">
<identifier><system value="http://example.org/synthpharma/epi"/><value value="urn:uuid:84f6753b-b61a-532f-b964-12ad7ab45fc6"/></identifier>
<type value="document"/>
<timestamp value="2027-03-10T11:15:00+01:00"/>
<entry>
<fullUrl value="urn:uuid:5db1cab5-6e8f-5623-8194-e175659d86a6"/>
<resource>
<Composition>
<status value="final"/>
<type><coding><system value="http://example.org/epi-section"/><code value="product-information"/><display value="Product information (SmPC and package leaflet)"/></coding></type>
<date value="2027-03-10T11:15:00+01:00"/>
<author><reference value="urn:uuid:233d1ca4-886c-5bc2-9f08-c074138c4a23"/><display value="SynthPharma AG"/></author>
<title value="WonderDrug 50 mg film-coated tablets — product information, version 5 (clean)"/>
<section>
<title value="Summary of Product Characteristics"/>
<code><coding><system value="http://example.org/epi-section"/><code value="smpc"/><display value="Summary of Product Characteristics"/></coding></code>
<section>
<title value="4.2 Posology and method of administration"/>
<code><coding><system value="http://example.org/epi-section"/><code value="smpc-4.2"/><display value="4.2 Posology and method of administration"/></coding></code>
<text><status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>The recommended dose is one 50 mg tablet once daily. WonderDrug may be taken with food to reduce nausea.</p></div></text>
</section>
<section>
<title value="4.8 Undesirable effects"/>
<code><coding><system value="http://example.org/epi-section"/><code value="smpc-4.8"/><display value="4.8 Undesirable effects"/></coding></code>
<text><status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Gastrointestinal disorders. Common: abdominal pain, nausea. Uncommon: dyspepsia.</p></div></text>
</section>
</section>
<section>
<title value="Package Leaflet"/>
<code><coding><system value="http://example.org/epi-section"/><code value="pil"/><display value="Package Leaflet"/></coding></code>
<section>
<title value="3. How to take WonderDrug"/>
<code><coding><system value="http://example.org/epi-section"/><code value="pil-3"/><display value="3. How to take WonderDrug"/></coding></code>
<text><status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Take one tablet once a day. Taking WonderDrug with food may help you feel less sick.</p></div></text>
</section>
<section>
<title value="4. Possible side effects"/>
<code><coding><system value="http://example.org/epi-section"/><code value="pil-4"/><display value="4. Possible side effects"/></coding></code>
<text><status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml"><p>Common (may affect up to 1 in 10 people): stomach pain, feeling sick (nausea). Uncommon (may affect up to 1 in 100 people): indigestion.</p></div></text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:233d1ca4-886c-5bc2-9f08-c074138c4a23"/>
<resource>
<Organization><name value="SynthPharma AG"/></Organization>
</resource>
</entry>
</Bundle>