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/cander2/apix-ig/ and changes regularly. See the Directory of published versions

Bundle: Type-II-Variation

Bundle Type-II-Variation of type transaction


Entry 1 - fullUrl = urn:uuid:task-001

Resource Task:

status: Requested

intent: Proposal

code: Submit Type II Variation

description: Type II variation for shelf life extension from 24 to 36 months

for: MedicinalProductDefinition/mpd-001

authoredOn: 2025-06-29

requester: Organization/pharma-inc

owner: Organization/ema

Request:

POST Task

Entry 2 - fullUrl = urn:uuid:doc-ref-001

Resource DocumentReference:

status: Current

type: Administrative report

content

Attachments

-ContentTypeDataSizeHashTitle
*application/jsonbase64dataplaceholde1234qZk+NkcGgWq6PiVxeFDCbJzQ2J0=Type II Variation Application Form Collection Bundle

content

Attachments

-ContentTypeDataSizeHashTitle
*application/jsonbase64dataplaceholde1234qZk+NkcGgWq6PiVxeFDCbJzQ2J0=ePI Storage Update Document Bundle

content

Attachments

-ContentTypeDataSizeHashTitle
*application/jsonbase64dataplaceholde1234qZk+NkcGgWq6PiVxeFDCbJzQ2J0=PQI Stability Data Collection Bundle

Request:

POST DocumentReference

Entry 3 - fullUrl = urn:uuid:provenance-001

Resource Provenance:

Generated Narrative: Provenance provenance-001

Provenance for Bundle: type = transaction

Summary

Recorded2025-06-29 17:25:00-0400

Agents

Typewho
authorOrganization/pharma-inc

Request:

POST Provenance

Entry 4 - fullUrl = urn:uuid:application-form-001

Resource Bundle:

Bundle application-form-001 of type collection


Entry 1 - fullUrl = urn:uuid:activity-definition-001

Resource ActivityDefinition:

Id: activity-definition-001
Status: draft
Description:

Type II variation application for shelf life extension from 24 to 36 months

Request:

POST Bundle

Entry 5 - fullUrl = urn:uuid:epi-bundle-001

Resource Bundle:

Document Details


Document Content

Storage

Store at 2-8°C for up to 36 months.

Additional Resources Included in Document

Request:

POST Bundle

Entry 6 - fullUrl = urn:uuid:pqi-bundle-001

Resource Bundle:

Bundle pqi-bundle-001 of type collection


Entry 1 - fullUrl = urn:uuid:observation-001

Resource Observation:

status: Final

code: Stability study

value: Stability data supports shelf life extension to 36 months

Request:

POST Bundle