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 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
| Page standards status: Informative |
version: 2; Last updated: 2025-11-20 14:30:00+0100
Profile: APIX Regulatory Task
identifier: Uniform Resource Identifier (URI)/urn:uuid:workflow-step1-instance (use: official, ), http://ema.europa.eu/procedure-number/EMEA/H/C/001234/IB/0025 (use: official, )
basedOn: Task Type IB Variation
groupIdentifier: Uniform Resource Identifier (URI)/urn:uuid:workflow-group-id-12345 (use: official, )
status: Accepted
businessStatus: Validation Successful
intent: order
priority: Routine
code: Type IB Variation
authoredOn: 2025-11-15 09:00:00+0100
lastModified: 2025-11-20 14:30:00+0100
requester: SynthPharma AG
owner: European Medicines Agency
input
type: Cover Letter
input
type: Regulatory Document
input
type: Regulatory Document
input
type: Regulatory Document
input
type: Regulatory Document
value: DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups
input
type: Stability Data
input
type: Stability Data
input
type: Stability Data
input
type: Stability Data
value: DocumentReference: status = current; type = DS Stability Summary
input
type: Stability Data
value: DocumentReference: status = current; type = DS Stability Data
output
type: Regulatory Document
value: DocumentReference: status = current; type = Acknowledgement of Receipt
output
type: Regulatory Document
value: DocumentReference: status = current; type = Validation Report