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: List-Of-Questions
Bundle List-Of-Questions of type transaction
Entry 1 - fullUrl = urn:uuid:task-002
Resource Task:
status: Requested
intent: Order
code: Respond to List of Questions
description: Provide responses to the List of Questions for Type II variation (shelf life extension)
for: MedicinalProductDefinition/mpd-001
authoredOn: 2025-06-29 17:56:00-0400
requester: Organization/ema
owner: Organization/pharma-inc
Request:
POST Task
Entry 2 - fullUrl = urn:uuid:loq-bundle-001
Resource Bundle:
Bundle loq-bundle-001 of type collection
Entry 1 - fullUrl = urn:uuid:questionnaire-001
Resource Questionnaire:
LinkID Text Cardinality Type Description & Constraints 
Questionnaire admin-1
Is the fee for the Type II variation fully paid and documented? 0..1 string Are all required metadata fields in the application form complete? 0..1 string Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance? 0..1 string Is the patient leaflet revised to clarify the extended shelf life? 0..1 string Is the updated ePI text sufficiently clear for all EU languages? 0..1 string Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies? 0..1 string Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies? 0..1 string Are the test methods used the same as in the previously submitted stability information? 0..1 string Are there any new degradation products identified within the newly submitted data? 0..1 string Any changes in the packaging configuration and/or storage of the samples during stability? 0..1 string Documentation for this format
Request:
POST Bundle
Entry 3 - fullUrl = urn:uuid:provenance-002
Resource Provenance:
Generated Narrative: Provenance provenance-002
Provenance for Bundle: type = transaction
Summary
Recorded 2025-06-29 17:56:00-0400 Agents
Type who author Organization/ema
Request:
POST Provenance