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
version: 1; Last updated: 2025-12-20 14:15:00+0000
Profile: APIX Regulatory Task
identifier: Task Instance UUID/urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example (use: official, )
status: Requested
intent: order
priority: Routine
code: New Drug Application (NDA)
authoredOn: 2025-12-20 14:15:00+0000
lastModified: 2025-12-20 14:15:00+0000
requester: Organization SynthPharma AG
owner: Organization European Medicines Agency
input
type: regulatory-document
input
type: regulatory-document
input
type: regulatory-document
Generated Narrative: Organization #org-synthpharma-ag
name: SynthPharma AG
Generated Narrative: Organization #org-ema
name: European Medicines Agency
Generated Narrative: DocumentReference #docref-m1-cover
version: 1.0
status: Current
docStatus: Final
type: Cover Letter
category: Module 1
content
Attachments
ContentType Url Size Title Creation application/pdf https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf 1250000 Cover Letter.pdf 2025-12-20 14:00:00+0000
Generated Narrative: DocumentReference #docref-m3-stability-data
version: 1.0
status: Current
docStatus: Final
type: Stability
category: Module 3
content
Attachments
ContentType Url Size Title Creation application/zip https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip 64424509440 Stability Data Package (60GB Referenced) 2025-12-15 10:00:00+0000
Generated Narrative: DocumentReference #docref-m5-clinical-study
version: 1.0
status: Current
docStatus: Final
type: Reports of Efficacy and Safety Studies
category: Module 5
content
Attachments
ContentType Url Size Title Creation application/pdf https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf 45000000 Clinical Study Report - Phase III.pdf 2025-12-18 09:00:00+0000