EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="ed38e7e5-235e-460e-b292-f6c220622d1c"/>
<meta>
<!-- this will exist but is commented out in the IG temporarily -->
<!-- profile value="http://hl7.org/fhir/5.0/StructureDefinition/Bundle" / -->
<profile
value="http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1"/>
<profile
value="http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5"/>
</meta>
<type value="transaction-response"/>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068"/>
<resource>
<MedicinalProductDefinition>
<id value="600000709068"/>
<meta>
<versionId value="4"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_600000709068"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 600000709068</b></p><a name="600000709068"> </a><a name="hc600000709068"> </a><a name="600000709068-en-US"> </a><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">version: 4</p></div><p><b>Authorised Dose Form</b>: <a href="CodeSystem-200000000004.html#200000000004-100000073683">Pharmaceutical Dose Form 100000073683</a>: Prolonged-release tablet</p><p><b>identifier</b>: <code>http://spor.azure-api.net/pms/api/v2</code>/6055417, <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>domain</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}">Nullified</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000000006 100000073683}">Prolonged-release tablet</span></p><p><b>additionalMonitoringIndicator</b>: <span title="Codes:{http://ema.europa.eu/fhir/additionalMonitoringIndicator False}">False</span></p><p><b>pediatricUseIndicator</b>: <span title="Codes:{http://ema.europa.eu/fhir/paediatricUseIndicator True}">True</span></p><p><b>classification</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000093533 100000098024}">100000098024</span>, <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000116045 100000116046}">Full application (Article 8(3) of Directive No 2001/83/EC)</span>, <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000000324 200000003517}">Other</span></p><p><b>attachedDocument</b>: <a href="DocumentReference-13709.html">DocumentReference: status = current</a></p><p><b>masterFile</b>: <a href="DocumentReference-mf1.html">DocumentReference: status = current</a></p><blockquote><p><b>contact</b></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 200000017719}">Pharmacovigilance Enquiry Information</span></p><p><b>contact</b>: <a href="Organization-phv5633366.html">Organization Dummmy Organization</a></p></blockquote><blockquote><p><b>contact</b></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 100000155057}">Qualified Person in the EEA for Pharmacovigilance</span></p><p><b>contact</b>: <a href="PractitionerRole-qppv5633367.html">PractitionerRole </a></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: StopCold 5 mg/120 mg comprimidos de liberación prolongada.</p><blockquote><p><b>part</b></p><p><b>part</b>: StopCold</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 5 MG/120 MG</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: COMPRIMIDOS DE LIBERACIÓN PROLONGADA</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></td><td><span title="Codes:{urn:ietf:bcp:47 es}, {http://spor.ema.europa.eu/v1/lists/100000072057 100000072264}">Spanish</span></td></tr></table></blockquote><blockquote><p><b>operation</b></p><blockquote><p><b>id</b></p>6519944</blockquote><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ActivityDefinition-7371703.html">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004984}">Confidential</span></p></blockquote></div>
</text>
<extension
url="http://ema.europa.eu/fhir/extension/authorisedDoseForm">
<valueCoding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="38"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073683"/>
</valueCoding>
</extension>
<identifier>
<system value="http://spor.azure-api.net/pms/api/v2"/>
<value value="6055417"/>
</identifier>
<identifier>
<system
value="http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"/>
<value value="PRD417562"/>
</identifier>
<domain>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="7"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
</coding>
</domain>
<status>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005007"/>
</coding>
</status>
<combinedPharmaceuticalDoseForm>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="38"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000000006"/>
<code value="100000073683"/>
</coding>
</combinedPharmaceuticalDoseForm>
<additionalMonitoringIndicator>
<coding>
<system
value="http://ema.europa.eu/fhir/additionalMonitoringIndicator"/>
<code value="False"/>
</coding>
</additionalMonitoringIndicator>
<pediatricUseIndicator>
<coding>
<system value="http://ema.europa.eu/fhir/paediatricUseIndicator"/>
<code value="True"/>
</coding>
</pediatricUseIndicator>
<classification>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000098024"/>
</coding>
</classification>
<classification>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="8"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000116045"/>
<code value="100000116046"/>
</coding>
</classification>
<classification>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="2"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000000324"/>
<code value="200000003517"/>
</coding>
</classification>
<attachedDocument>🔗
<reference value="DocumentReference/13709"/>
</attachedDocument>
<masterFile>🔗
<reference value="DocumentReference/mf1"/>
</masterFile>
<contact>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000154441"/>
<code value="200000017719"/>
</coding>
</type>
<contact>🔗
<reference value="Organization/phv5633366"/>
</contact>
</contact>
<contact>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="1"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000154441"/>
<code value="100000155057"/>
</coding>
</type>
<contact>🔗
<reference value="PractitionerRole/qppv5633367"/>
</contact>
</contact>
<name>
<productName
value="StopCold 5 mg/120 mg comprimidos de liberación prolongada."/>
<part>
<part value="StopCold"/>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="9"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
</coding>
</type>
</part>
<part>
<part value="5 MG/120 MG"/>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="9"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
</coding>
</type>
</part>
<part>
<part value="COMPRIMIDOS DE LIBERACIÓN PROLONGADA"/>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="8"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="19"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000529"/>
</coding>
</country>
<language>
<!-- language needs an international code, which matches the RMS code -->
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="es"/>
</coding>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="2"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000072057"/>
<code value="100000072264"/>
</coding>
</language>
</usage>
</name>
<operation id="6519944">
<type>
<reference>🔗
<reference value="ActivityDefinition/7371703"/>
</reference>
</type>
<confidentialityIndicator>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/200000004983"/>
<code value="200000004984"/>
</coding>
</confidentialityIndicator>
</operation>
</MedicinalProductDefinition>
</resource>
<response>
<status value="200"/>
<location value="MedicinalProductDefinition/600000709068"/>
</response>
</entry>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/PackagedProductDefinition/7868766"/>
<resource>
<PackagedProductDefinition>
<id value="7868766"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_7868766"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 7868766</b></p><a name="7868766"> </a><a name="hc7868766"> </a><a name="7868766-en-US"> </a><p><b>identifier</b>: <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>packageFor</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068">Bundle: type = searchset</a></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}">Nullified</span></p><p><b>containedItemQuantity</b>: 40(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014)<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation code200000002152 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>5MG/120MG PROLONGED RELEASE TABLET</p>
</div></div>
</text>
<identifier>
<system
value="http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"/>
<value value="PRD417562"/>
</identifier>
<packageFor>
<reference value="MedicinalProductDefinition/600000709068"/>
</packageFor>
<status>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005007"/>
</coding>
</status>
<containedItemQuantity>
<value value="40"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description value="5MG/120MG PROLONGED RELEASE TABLET">
<extension url="http://hl7.org/fhir/StructureDefinition/language">
<!-- language needs an international code, which matches the RMS code -->
<valueCode value="es"/>
</extension>
<extension url="http://ema.europa.eu/fhir/extension/language">
<valueCoding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="2"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000072057"/>
<code value="100000072264"/>
</valueCoding>
</extension>
</description>
</PackagedProductDefinition>
</resource>
<response>
<status value="200"/>
<location value="PackagedProductDefinition/7868766"/>
</response>
</entry>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/ActivityDefinition/7371703"/>
<resource>
<ActivityDefinition>
<id value="7371703"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_7371703"> </a>
<div>
<table class="grid dict">
<tr>
<th scope="row"><b>Id: </b></th>
<td style="padding-left: 4px;">7371703</td>
</tr>
<tr>
<th scope="row"><b>Effective Period: </b></th>
<td style="padding-left: 4px;">2024-12-01..</td>
</tr>
<tr>
<th scope="row"><b>Code: </b></th>
<td style="padding-left: 4px;">
<p><b>system: </b><span><a href="CodeSystem-100000160406.html">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>
<p><b>code: </b><span>100000160478</span></p>
</td>
</tr>
</table>
</div>
</div>
</text>
<status value="active"/>
<effectivePeriod>
<start value="2024-12-01"/>
</effectivePeriod>
<code>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/100000160406"/>
<code value="100000160478"/>
</coding>
</code>
<participant>
<type value="organization"/>
<typeReference>
<identifier>
<system value="http://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100068457"/>
</identifier>
<display value="1 4 U Pharma GmbH"/>
</typeReference>
</participant>
</ActivityDefinition>
</resource>
<response>
<status value="200"/>
<location value="ActivityDefinition/7371703"/>
</response>
</entry>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/RegulatedAuthorization/6756012"/>
<resource>
<RegulatedAuthorization>
<id value="6756012"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6756012"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6756012</b></p><a name="6756012"> </a><a name="hc6756012"> </a><a name="6756012-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068">Bundle: type = searchset</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p><p><b>holder</b>: Kern Pharma S.L. (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100002956)</p><p><b>regulator</b>: ES (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/ES)</p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154442 100000155062}">National Procedure</span></td></tr></table></div>
</text>
<identifier>
<system
value="http://ema.europa.eu/fhir/MarketingAuthorizationNumber"/>
<value value="62.102"/>
</identifier>
<subject>
<reference value="MedicinalProductDefinition/600000709068"/>
</subject>
<type>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="1"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
</coding>
</type>
<region>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="22"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000529"/>
</coding>
</region>
<status>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="200000032263"/>
</coding>
</status>
<statusDate value="2025-02-18T00:00:00Z"/>
<holder>
<identifier>
<system value="http://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100002956"/>
</identifier>
<display value="Kern Pharma S.L."/>
</holder>
<regulator>
<identifier>
<system value="http://spor.ema.europa.eu/v1/locations"/>
<value value="ES"/>
</identifier>
<display value="ES"/>
</regulator>
<case>
<type>
<coding>
<extension
url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="14"/>
</extension>
<system
value="http://spor.ema.europa.eu/v1/lists/100000154442"/>
<code value="100000155062"/>
</coding>
</type>
</case>
</RegulatedAuthorization>
</resource>
<response>
<status value="200"/>
<location value="RegulatedAuthorization/6756012"/>
</response>
</entry>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/RegulatedAuthorization/6362767"/>
<resource>
<RegulatedAuthorization>
<id value="6362767"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6362767"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6362767</b></p><a name="6362767"> </a><a name="hc6362767"> </a><a name="6362767-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#PackagedProductDefinition_7868766">Bundle: type = searchset</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p></div>
</text>
<identifier>
<system
value="http://ema.europa.eu/fhir/MarketingAuthorizationNumber"/>
<value value="62.102"/>
</identifier>
<subject>
<reference value="PackagedProductDefinition/7868766"/>
</subject>
<type>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="1"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
</coding>
</type>
<region>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="22"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000529"/>
</coding>
</region>
<status>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/termVersion">
<valueInteger value="3"/>
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="200000032263"/>
</coding>
</status>
<statusDate value="2025-02-18T00:00:00Z"/>
</RegulatedAuthorization>
</resource>
<response>
<status value="200"/>
<location value="RegulatedAuthorization/6362767"/>
</response>
</entry>
<entry>
<fullUrl
value="http://ema.europa.eu/example/api/RegulatedAuthorization/6094279"/>
<resource>
<RegulatedAuthorization>
<id value="6094279"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6094279"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6094279</b></p><a name="6094279"> </a><a name="hc6094279"> </a><a name="6094279-en-US"> </a><p><b>subject</b>: <a href="ActivityDefinition-7371703.html">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2024-12-01 --> (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>
</text>
<subject>🔗
<reference value="ActivityDefinition/7371703"/>
</subject>
<type>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000099"/>
</coding>
</type>
<validityPeriod>
<start value="2024-12-01"/>
</validityPeriod>
<regulator>
<identifier>
<system value="http://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100000015"/>
</identifier>
<display value="Finnish Medicines Agency"/>
</regulator>
</RegulatedAuthorization>
</resource>
<response>
<status value="200"/>
<location value="RegulatedAuthorization/6094279"/>
</response>
</entry>
</Bundle>