Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions
This example demonstrates a synthetic regulatory questionnaire response submitted by a marketing authorization holder (MAH) during a Type II variation procedure, using FHIR R5 QuestionnaireResponse resources for structured, machine-readable exchange.
FHIR Integration Highlights
QuestionnaireResponse.item with a linkId matching the original question (e.g., "admin-1").Questionnaire and includes submission timestamp (authored).Response to EMA List of Questions – Type II Variation (ID001)
Procedure Number: EMEA/H/C/005432/II/0023 | Submitted: November 15, 2025
Dr. John Doe
Head of Regulatory Affairs
SynthPharma AG
Global Regulatory Strategy
Basel, Switzerland
123 Synthetic Research Blvd, 4000 Basel, Switzerland
Dr. Jane Doe
Scientific Officer
Scientific and Regulatory Management
Human Medicines Evaluation Division
European Medicines Agency
jane.doe@ema.europa.eu | +31-88-781-6000
Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
See EMA Fee Guidance for payment confirmation requirements.
Yes, the fee was paid on June 25, 2025. Payment confirmation and receipt are included in the application form (see Section 1.1).
Yes, all required metadata fields are complete:
Current ePI states: “Store in a refrigerator (2°C – 8°C). Do not freeze.”
No additional patient guidance is required. The ePI clearly states: 'Store in a refrigerator (2°C – 8°C). Do not freeze.' The 36-month shelf life is supported by stability data and does not alter patient handling instructions.
“Shelf life after first opening: 36 months when stored at 2–8°C”
Yes, the patient leaflet has been updated to state: 'Shelf life after first opening: 36 months when stored at 2–8°C'. The revised leaflet is included in the submission.
| Language | Status |
|---|---|
| English | Approved |
| French | Under Review |
| German | Pending |
Yes, the ePI text has been translated into all EU languages and reviewed for clarity. All versions are linguistically validated. Status: English (Approved), French (Approved), German (Approved), others (Final review completed).
The submission includes both:
No protocol deviations occurred. All studies follow ICH Q1A(R2).
Yes, the data supports all ICH climatic zones, including Zone IVb:
All batches remain within specification.
If changed: justify and provide validation data.
Yes, all test methods are identical to those validated in the original MAA. No changes were made. Methods remain stability-indicating for assay, impurities, and dissolution.
Threshold: >0.10% per ICH Q3B(R2)
No new degradation products were identified. All observed impurities correspond to previously qualified degradants. Levels remain below 0.10% (ICH Q3B(R2) threshold). No peaks above reporting threshold detected.
Figure 1: Cross-section of new Alu/Alu blister showing foil thickness and sealing layer.
| Original | New |
|---|---|
| PVC/PVDC Blister | Alu/Alu Blister |
| 25°C/60% RH | Unchanged |
Yes, a change in packaging configuration was implemented:
New stability studies (B-001, B-002) were initiated in the Alu/Alu system. Storage conditions remain unchanged: 25°C/60% RH (long-term), 40°C/75% RH (accelerated).
Figure 1: Cross-section of new Alu/Alu blister showing foil thickness and sealing layer.
| Parameter | Original | New |
|---|---|---|
| Material | PVC/PVDC | Alu/Alu |
| Storage Condition | 25°C/60% RH | Unchanged |