Regulatory Workflows and Interactions - pharma
0.1.0 - ci-build
Regulatory Workflows and Interactions - pharma
0.1.0 - ci-build
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 ICH E2B(R3) message: the structure follows the
E2B(R3) HL7 v3 schema (MCCI_IN200100UV01 batch / PORR_IN049016UV message) but only key data elements are
shown, and it has not been validated against the ICH schemas. Data element numbers are given in comments. -->
<MCCI_IN200100UV01 xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ITSVersion="XML_1.0">
<id root="2.16.840.1.113883.3.989.2.1.3.22" extension="SYNTH-BATCH-2026-000131"/> <!-- N.1.2 batch number -->
<creationTime value="20261009101500+0200"/> <!-- N.1.5 date of batch transmission -->
<responseModeCode code="D"/>
<interactionId root="2.16.840.1.113883.1.6" extension="MCCI_IN200100UV01"/>
<name code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.1" displayName="ichicsr"/> <!-- N.1.1 type of messages in batch -->
<PORR_IN049016UV>
<id root="2.16.840.1.113883.3.989.2.1.3.1" extension="SYNTH-MSG-2026-000456-2"/> <!-- N.2.r.1 message identifier -->
<creationTime value="20261009101500+0200"/> <!-- N.2.r.4 date of message creation -->
<interactionId root="2.16.840.1.113883.1.6" extension="PORR_IN049016UV"/>
<processingCode code="P"/>
<processingModeCode code="T"/>
<acceptAckCode code="AL"/>
<receiver typeCode="RCV"><device classCode="DEV" determinerCode="INSTANCE"><id root="2.16.840.1.113883.3.989.2.1.3.12" extension="HA-PHARMACOVIGILANCE"/></device></receiver> <!-- N.2.r.3 -->
<sender typeCode="SND"><device classCode="DEV" determinerCode="INSTANCE"><id root="2.16.840.1.113883.3.989.2.1.3.11" extension="SYNTHPHARMA-AG"/></device></sender> <!-- N.2.r.2 -->
<controlActProcess classCode="CACT" moodCode="EVN">
<code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18"/>
<effectiveTime value="20261009101500+0200"/> <!-- C.1.2 date of creation -->
<subject typeCode="SUBJ">
<investigationEvent classCode="INVSTG" moodCode="EVN">
<id root="2.16.840.1.113883.3.989.2.1.3.1" extension="CH-SYNTHPHARMA-2026-000456"/> <!-- C.1.1 sender's safety report unique identifier -->
<id root="2.16.840.1.113883.3.989.2.1.3.2" extension="CH-SYNTHPHARMA-2026-000456"/> <!-- C.1.8.1 worldwide unique case identification number -->
<code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4"/>
<text>54-year-old female patient started WonderDrug 50 mg tablets once daily on 20-Sep-2026. On 26-Sep-2026 she developed nausea. The reporting physician considered the event non-serious and possibly related. Follow-up 08-Oct-2026: WonderDrug was withdrawn on 30-Sep-2026 and the nausea resolved on 05-Oct-2026 (positive dechallenge).</text> <!-- H.1 case narrative -->
<statusCode code="active"/>
<effectiveTime><low value="20260928"/></effectiveTime> <!-- C.1.4 date report was first received from source -->
<availabilityTime value="20261008"/> <!-- C.1.5 date of most recent information -->
<component typeCode="COMP">
<adverseEventAssessment classCode="INVSTG" moodCode="EVN">
<subject1 typeCode="SBJ">
<primaryRole classCode="INVSBJ">
<player1 classCode="PSN" determinerCode="INSTANCE">
<name>JD</name> <!-- D.1 patient (initials) -->
<administrativeGenderCode code="2" codeSystem="1.0.5218" displayName="female"/> <!-- D.5 sex -->
</player1>
<subjectOf2 typeCode="SBJ">
<observation classCode="OBS" moodCode="EVN">
<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="age"/>
<value xsi:type="PQ" value="54" unit="a"/> <!-- D.2.2 age at time of onset -->
</observation>
</subjectOf2>
<subjectOf2 typeCode="SBJ">
<observation classCode="OBS" moodCode="EVN">
<id root="2.16.840.1.113883.3.989.2.1.3.8" extension="R1"/>
<code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reaction"/>
<effectiveTime xsi:type="IVL_TS"><low value="20260926"/><high value="20261005"/></effectiveTime> <!-- E.i.4 / E.i.5 -->
<value xsi:type="CE" code="10028813" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="29.0" displayName="Nausea"/> <!-- E.i.2.1b MedDRA PT -->
<outboundRelationship2 typeCode="PERT">
<observation classCode="OBS" moodCode="EVN">
<code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="outcome"/>
<value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" displayName="recovered/resolved"/> <!-- E.i.7 outcome -->
</observation>
</outboundRelationship2>
</observation>
</subjectOf2>
<subjectOf2 typeCode="SBJ">
<organizer classCode="CATEGORY" moodCode="EVN">
<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugInformation"/>
<component typeCode="COMP">
<substanceAdministration classCode="SBADM" moodCode="EVN">
<id root="2.16.840.1.113883.3.989.2.1.3.5" extension="D1"/>
<consumable typeCode="CSM"><instanceOfKind classCode="INST"><kindOfProduct classCode="MMAT" determinerCode="KIND">
<name>WonderDrug 50 mg tablets</name> <!-- G.k.2.2 medicinal product name as reported -->
</kindOfProduct></instanceOfKind></consumable>
<outboundRelationship2 typeCode="COMP"><substanceAdministration classCode="SBADM" moodCode="EVN">
<effectiveTime xsi:type="IVL_TS"><low value="20260920"/><high value="20260930"/></effectiveTime> <!-- G.k.4.r.4 / G.k.4.r.5 -->
<doseQuantity value="50" unit="mg"/> <!-- G.k.4.r.1 dose -->
</substanceAdministration></outboundRelationship2>
<!-- G.k.8 action taken with drug: drug withdrawn -->
<inboundRelationship typeCode="CAUS"><act classCode="ACT" moodCode="EVN"><code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.15" displayName="drug withdrawn"/></act></inboundRelationship>
</substanceAdministration>
</component>
</organizer>
</subjectOf2>
</primaryRole>
</subject1>
</adverseEventAssessment>
</component>
<outboundRelationship typeCode="SPRT">
<relatedInvestigation classCode="INVSTG" moodCode="EVN">
<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="sourceReport"/>
<subjectOf2 typeCode="SUBJ"><controlActEvent classCode="CACT" moodCode="EVN"><author typeCode="AUT"><assignedEntity classCode="ASSIGNED">
<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.6" displayName="physician"/> <!-- C.2.r.4 qualification -->
</assignedEntity></author></controlActEvent></subjectOf2>
</relatedInvestigation>
</outboundRelationship>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="OBS" moodCode="EVN">
<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="ichReportType"/>
<value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.2" displayName="Spontaneous report"/> <!-- C.1.3 type of report -->
</investigationCharacteristic>
</subjectOf2>
</investigationEvent>
</subject>
</controlActProcess>
</PORR_IN049016UV>
</MCCI_IN200100UV01>
IG © 2025+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.apix#0.1.0 based on FHIR 5.0.0.
Generated
2026-10-19
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