Artifacts Summary

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

Contents:

Structures: Resource Profiles
Terminology: Value Sets
Terminology: Code Systems
Example: Example Instances

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

APIX Endpoint for FHIR Subscription Notifications

Endpoint requiring identifier, name, and connectionType of hl7-fhir-subscription-notify.

APIX Organization

Organization profile for APIX regulatory workflows, derived from and compatible with ePI requirements.

APIX Regulatory DocumentReference

DocumentReference profile used in APIX regulatory submissions. Supports both embedded base64 data and referenced binaries via URL (Index Pattern). Includes support for versioning, lifecycle status, and CTD section categorization.

APIX Regulatory Task

Task profile for APIX regulatory submission workflows

APIX Task Assignment and Creation With Organization Filter

SubscriptionTopic notifying an organization when a Task is created and assigned to them.

APIX Task Status Change With Identifier Filter

Triggers when a Task.status value changes and allows filtering by Task.identifier.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

APIX CTD/eCTD Section Code System

Value set for CTD section codes used in APIX regulatory submissions

APIX Regulatory Business Status

Value set for regulatory business status in APIX submissions

APIX Submission Types

Value set for submission types in APIX regulatory procedures

APIX Task Codes ValueSet

Value set for task codes in APIX regulatory submissions

APIX Task Input Types

Value set for task input types in APIX regulatory submissions

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

APIX CTD/eCTD Section Code System

Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH M4 guidelines.

APIX Regulatory Business Status

Code system for regulatory business status in APIX submissions

APIX Task Code System

Code system for regulatory task types in APIX submissions

APIX Task Input Types Code System

Code system for task input types in APIX regulatory submissions

APIX Task Output Types Code System

Code system for task output types in APIX regulatory submissions

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Example APIX interaction Endpoint with header

Example APIX interaction Endpoint with header information; payload is very loosely defined, sufficient where payload considerations are handled internally and not exposed. Note identifier. n

Example basic APIX interaction Endpoint

Example basic APIX interaction Endpoint, payload is very loosely defined; payload considerations are handled internally and not exposed. Note identifier.

Invoice #INV-2025-001

Financial invoice for regulatory submission review

Organization example with Endpoint

Organization example with Endpoint.

Subscription for Task Status Change with Identifier Filter

Subscription example to Task change status with an identifier filter, and sending full-resource.

SubscriptionNotification Task ID Only

SubscriptionNotification Bundle example Task id only.

Task Assignment and Creation With Organization Filter

SubscriptionTopic for a health authority to notify an organization when that organization has been assigned a new Task.

Task Status Change With Identifier Filter

Triggers when a Task.status value changes. Allows subscriptions to filter by Task.identifier.