scenario1 06 technical response - API for the Exchange of Medicinal Product Information (APIX) v0.1.0

API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

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

Example Task: scenario1 06 technical response

Page standards status: Informative

Task: Response to Information Request

HL7 FHIR R5 – APIX Implementation Guide

Task Description

Response to Questions: Submission of additional stability data

Core Task Information

Version ID3Task IDIn production this would be the same as scenario1-05-technical-questionInstance UUIDurn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3cGroup Identifierurn:uuid:workflow-group-id-12345Parent Taskscenario1-01-initial-submissionTask StatusrequestedBusiness StatusSubmittedIntentproposalPriorityroutine

CodeResponse to Information Request (response-to-questions)Authored2025-12-01T14:30:00+01:00Last Updated2025-12-05T10:00:00+01:00 Request Start Time2025-12-01T14:30:00+01:00 Request Answer By2025-12-08T14:30:00+01:00

Parties Involved

Requester

SynthPharma AG

Address: 123 Synthetic Research Blvd, 4000 Basel, Switzerland
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example

Performer

European Medicines Agency – Human Medicines Evaluation Division

Address: Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
Contact: Scientific and Regulatory Management
Email: srm@ema.example.eu

Input Documents1 documents

Input Documents (Questions)

List of Questions (LoQ)

regulatory-document
http://example.org/FHIR/DocumentReference/docref-list-of-questions

list of questions

Output Documents2 documents

Output Documents (Responses)

Applicant Responses

regulatory-document
http://example.org/FHIR/DocumentReference/docref-responses-qresponse