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

API for the Exchange of Medicinal Product Information (APIX), 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

Getting Started

Page standards status: Informative

Getting Started with APIX

Whether you are a Regulatory Authority building an API gateway, a Pharmaceutical company connecting your RIM system, or a Technology Vendor building integration software — choose your path below.

Choose Your Path

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Pharmaceutical Industry

You want to automate regulatory submissions, track procedures in real-time, and eliminate manual portal uploads.

  1. Review the Use Cases
  2. Study the Workflow Overview
  3. Configure your RIM system for FHIR R5 Task-based exchange
  4. Test with the reference implementation
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Regulatory Authorities

You are building or modernizing your regulatory exchange infrastructure with API-first architecture.

  1. Review the Architecture
  2. Set up an R5-compliant FHIR server
  3. Configure SubscriptionTopics
  4. Test subscription notifications
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Technology Vendors

You are building RIM integrations, regulatory gateways, or FHIR server implementations for pharma and regulators.

  1. Study the FHIR Profiles
  2. Review the Interaction Pattern
  3. Implement the Task workflow
  4. Validate with the HL7 Validator
The journey is incremental

You don't need to implement the entire specification on day one. Start with a simple Task-based submission to establish connectivity, then progressively add real-time subscriptions and document exchange as your infrastructure matures.

Prerequisites

Required
FHIR R5 Server

An R5-compliant FHIR server with support for Subscriptions, conditional create/update, and SMART Backend Services (e.g., HAPI FHIR, Smile CDR, Azure, AWS HealthLake, GCP Healthcare API).

Required
OAuth2 / SMART

SMART Backend Services for system-level authentication using JWT bearer tokens. Mandatory for production use to ensure secure, audited access.

Recommended
REST API Client

A REST client (e.g., Postman, cURL, or your RIM system) capable of sending FHIR JSON payloads over HTTPS. Essential for prototyping and testing.

Quick Reference

Essential starting points for each core APIX capability.

Validate & Build

Once you have reviewed the architecture and workflow:

  1. Validate your FHIR resources — Use the Official FHIR Validator with the APIX IG package to check compliance with the profiles defined in this guide.
  2. Test end-to-end — Post a Task to a test FHIR server, subscribe to status changes, and verify that notifications arrive at your webhook endpoint.
  3. Connect your RIM — Use the provided examples as templates. Start with a simple shelf-life variation submission to establish connectivity.