API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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

Use Cases

In development

EMA Regulatory Questionnaire Request

Task-based model for pharmacovigilance data collection on Aspirin 100mg Tablets

FHIR R5 Task Example

Request Summary (click to toggle details)

What’s This About?
EMA needs safety data from Acme Pharmaceuticals on how Aspirin 100mg Tablets is used in children, including any side effects.
When’s It Due?
November 27, 2025
Tracking Number
EMA-INFOREQ-2025-112

Who’s Involved?

ER
Dr. Elena Rossi
EMA – Sending the Request
elena.rossi@ema.europa.eu
JC
Mr. James Carter
Acme Pharmaceuticals – To Respond
james.carter@acmepharm.com

Questionnaire (click for FHIR details)

Form Title
Post-Market Pediatric Safety Data Request – Aspirin 100mg
How It’s Delivered
Secure XML file embedded in the Task (base64-encoded for transmission)
Sample Question
Number of pediatric adverse event reports in the past 12 months
View FHIR XML Snippet 
<Task>
  <id value="ema-questionnaire-request-001"/>
  <status value="requested"/>
  <intent value="proposal"/>
  <code>
    <coding>
      <system value="http://hl7.org/fhir/CodeSystem/task-code"/>
      <code value="questionnaire-distribution"/>
    </coding>
  </code>
  <requester>
    <reference value="#ema-org"/>
  </requester>
  <owner>
    <reference value="#acmepharm-org"/>
  </owner>
  <input>
    <type>
      <coding>
        <code value="attachment"/>
      </coding>
    </type>
    <valueAttachment>
      <contentType value="application/fhir+xml"/>
      <data value="UEsDBBQAAAAIAG...[BASE64]"/>
    </valueAttachment>
  </input>
</Task>

Part of the APIX Task-based Regulatory Model • Full IG