Regulatory Workflows and Interactions - pharma
0.1.0 - ci-build International flag

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

Example Binary: binary-icsr-initial-ack

    
<?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_IN200101UV01 acknowledgment) 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_IN200101UV01 xmlns="urn:hl7-org:v3" ITSVersion="XML_1.0">
  <id root="2.16.840.1.113883.3.989.2.1.3.20" extension="HA-ACK-2026-778001"/>
  <creationTime value="20261002094512+0200"/>
  <interactionId root="2.16.840.1.113883.1.6" extension="MCCI_IN200101UV01"/>
  <MCCI_IN000002UV01>
    <id root="2.16.840.1.113883.3.989.2.1.3.24" extension="HA-ACK-2026-778001-1"/>
    <creationTime value="20261002094512+0200"/>
    <interactionId root="2.16.840.1.113883.1.6" extension="MCCI_IN000002UV01"/>
    <processingCode code="P"/>
    <processingModeCode code="T"/>
    <acceptAckCode code="NE"/>
    <receiver typeCode="RCV"><device classCode="DEV" determinerCode="INSTANCE"><id root="2.16.840.1.113883.3.989.2.1.3.18" extension="SYNTHPHARMA-AG"/></device></receiver>
    <sender typeCode="SND"><device classCode="DEV" determinerCode="INSTANCE"><id root="2.16.840.1.113883.3.989.2.1.3.17" extension="HA-PHARMACOVIGILANCE"/></device></sender>
    <acknowledgement typeCode="CA">                                                   <!-- ACK.B.r.6 report acknowledgment code: CA = commit accept -->
      <targetMessage><id root="2.16.840.1.113883.3.989.2.1.3.1" extension="SYNTH-MSG-2026-000456-1"/></targetMessage>  <!-- the ICSR message being acknowledged -->
    </acknowledgement>
  </MCCI_IN000002UV01>
  <acknowledgement typeCode="AA">                                                     <!-- ACK.A.4 transmission acknowledgment code: AA = all reports loaded -->
    <targetBatch><id root="2.16.840.1.113883.3.989.2.1.3.22" extension="SYNTH-BATCH-2026-000123"/></targetBatch>  <!-- the batch being acknowledged -->
  </acknowledgement>
</MCCI_IN200101UV01>