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-Response
Bundle List-Of-Questions-Response of type transaction
Entry 1 - fullUrl = urn:uuid:task-003
Resource Task:
status: Completed
intent: Order
code: Submit Response to List of Questions
description: Submission of responses to the List of Questions for Type II variation (shelf life extension)
for: MedicinalProductDefinition/mpd-001
authoredOn: 2025-06-29 18:15:00-0400
requester: Organization/pharma-inc
owner: Organization/ema
Request:
POST Task
Entry 2 - fullUrl = urn:uuid:response-bundle-001
Resource Bundle:
Bundle response-bundle-001 of type collection
Entry 1 - fullUrl = urn:uuid:questionnaire-response-001
Resource QuestionnaireResponse:
LinkID Text Definition Answer questionnaire-response-001
Questionnaire:Questionnaire/questionnaire-001 admin-1
Is the fee for the Type II variation fully paid and documented? Yes, the fee was paid on June 25, 2025, with documentation included in the application form. Are all required metadata fields in the application form complete? All metadata fields are complete, as verified against EMA guidelines. Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance? No additional guidance is needed; the ePI clearly states storage at 2-8°C for 36 months. Is the patient leaflet revised to clarify the extended shelf life? Yes, the patient leaflet has been updated to reflect the 36-month shelf life. Is the updated ePI text sufficiently clear for all EU languages? The ePI text has been translated and reviewed for clarity in all EU languages. Do stability studies cover all required environmental conditions for 36 months? Yes, stability studies include temperature, humidity, and light conditions for 36 months, per ICH guidelines. Are analytical methods validated for detecting degradation over 36 months? Analytical methods are fully validated, with results included in the PQI submission. Are new impurities identified in extended stability studies? No new impurities were identified; all impurities are within acceptable limits. Is the container closure system validated for 36 months? Are degradation products fully characterized for 36 months? Degradation products are fully characterized. No significant changes were observed in the 36-month stability studies. All identified degradation products remain within acceptable limits, as detailed in the PQI submission. Documentation for this format
Request:
POST Bundle
Entry 3 - fullUrl = urn:uuid:provenance-003
Resource Provenance:
Generated Narrative: Provenance provenance-003
Provenance for Bundle: type = transaction
Summary
Recorded 2025-06-29 18:15:00-0400 Agents
Type who author Organization/pharma-inc
Request:
POST Provenance