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

Example Task: scenario1 01 initial submission

Page standards status: Informative

version: 1; Last updated: 2025-11-15 09:00:00+0100

Profile: APIX Regulatory Task

identifier: Uniform Resource Identifier (URI)/urn:uuid:workflow-step1-instance (use: official, )

groupIdentifier: Uniform Resource Identifier (URI)/urn:uuid:workflow-group-id-12345 (use: official, )

status: Requested

businessStatus: Submitted

intent: order

priority: Routine

code: Type IB Variation

authoredOn: 2025-11-15 09:00:00+0100

lastModified: 2025-11-15 09:00:00+0100

requester: SynthPharma AG

owner: European Medicines Agency

input

type: Cover Letter

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1

input

type: Regulatory Document

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Application Form; category = Module 1

input

type: Regulatory Document

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Annotated Label; category = Module 1

input

type: Regulatory Document

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Clean Label; category = Module 1

input

type: Regulatory Document

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups

input

type: Stability Data

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Summary; category = Module 3

input

type: Stability Data

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Data; category = Module 3

input

type: Stability Data

value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Commitment; category = Module 3