CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<RegulatedAuthorization xmlns="http://hl7.org/fhir">
<id value="MA-12345601"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MA-12345601</b></p><a name="MA-12345601"> </a><a name="hcMA-12345601"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-regulatedauthorization.html">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-AuthNo.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Marketing Authorisation Number</a>/12345601</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Comprehensive-Sample-Combipack.html">MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic</a></p><p><b>type</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 756000002001}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></p><p><b>status</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}">approved</span></p><p><b>statusDate</b>: 2023-11-07</p><p><b>validityPeriod</b>: 2023-11-07 --> 2028-11-06</p><p><b>holder</b>: <a href="#hcMA-12345601/holder-Example-AG">Organization Example AG</a></p><p><b>regulator</b>: <a href="#hcMA-12345601/regulator-SMC">Organization SMC</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #holder-Example-AG</b></p><a name="MA-12345601/holder-Example-AG"> </a><a name="hcMA-12345601/holder-Example-AG"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-SMCLocID.html" title="Temporary NamingSystem in this implementation guide until officially released by Swissmedic">Swissmedic Location Identifier</a>/12345678, <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/0123456789, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601123456789</p><p><b>name</b>: Example AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name="MA-12345601/regulator-SMC"> </a><a name="hcMA-12345601/regulator-SMC"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-organization.html">Organization</a></p></div><p><b>identifier</b>: <a href="NamingSystem-LOC.html" title="Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)">LOC Identifier</a>/100010911, <a href="NamingSystem-GLN.html" title="Identifier holding a number for GLN (Global Location Number)">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>
</text>
<contained>
<Organization>
<id value="holder-Example-AG"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://www.swissmedic.ch/fhir/identifier/locations"/>
<value value="12345678"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="0123456789"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601123456789"/>
</identifier>
<name value="Example AG"/>
</Organization>
</contained>
<contained>
<Organization>
<id value="regulator-SMC"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"/>
</meta>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="100010911"/>
</identifier>
<identifier>
<system value="urn:oid:2.51.1.3"/>
<value value="7601001398511"/>
</identifier>
<name value="SMC"/>
</Organization>
</contained>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/authno"/>
<value value="12345601"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Comprehensive-Sample-Combipack"/>
</subject>
<type>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs"/>
<code value="756000002001"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</region>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status"/>
<code value="756005010000001"/>
<display value="approved"/>
</coding>
</status>
<statusDate value="2023-11-07"/>
<validityPeriod>
<start value="2023-11-07"/>
<end value="2028-11-06"/>
</validityPeriod>
<holder>
<reference value="#holder-Example-AG"/>
</holder>
<regulator>
<reference value="#regulator-SMC"/>
</regulator>
</RegulatedAuthorization>