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

Question Example

This example demonstrates a synthetic regulatory questionnaire issued during a Type II variation procedure, using FHIR R5 Questionnaire resources for structured, machine-readable exchange.

FHIR Integration Highlights

Each question maps to a Questionnaire.item with a linkId (e.g., "1").
Responses are captured in a QuestionnaireResponse resource (due 2025-12-11).
Supports multilingual ePI updates, stability data, and ICH/WHO zone alignment.

View the underlying FHIR Questionnaire resource (generated via FSH).

Regulatory Questionnaire

EMA List of Questions – Type II Variation (ID001)

Procedure Number: EMEA/H/C/005432/II/0023 | Response due: 2025-12-11

Sender: European Medicines Agency

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

Recipient: SynthPharma AG

Dr. John Doe

Head of Regulatory Affairs

SynthPharma AG
Global Regulatory Strategy
Basel, Switzerland

john.doe@synthpharma.example

123 Synthetic Research Blvd, 4000 Basel, Switzerland

Questionnaire: RegulatoryQA-ID001

1.0 Administrative Information → 1.1 Application Form

Is the fee for the Type II variation fully paid and documented?

See EMA Fee Guidance for payment confirmation requirements.

1.0 Administrative Information → 1.1 Application Form

Are all required metadata fields in the application form complete?

Marketing Authorisation Holder
Product Name (INN)
Procedure Number
Submission Date

1.3 Product Information → 1.3.1 SmPC, Labelling and Package Leaflet

Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?

Current ePI states: “Store in a refrigerator (2°C – 8°C). Do not freeze.”

1.3 Product Information → 1.3.1 SmPC, Labelling and Package Leaflet

Is the patient leaflet revised to clarify the extended shelf life?

“Shelf life after first opening: 36 months when stored at 2–8°C”

1.3 Product Information → 1.3.1 SmPC, Labelling and Package Leaflet

Is the updated ePI text sufficiently clear for all EU languages?

Language	Status
English	Approved
French	Under Review
German	Pending

3.2.P.8 Stability → 3.2.P.8.1 Stability Summary and Conclusion

Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?

Include protocol deviations if any.
Reference: ICH Q1A(R2)

3.2.P.8 Stability → 3.2.P.8.1 Stability Summary and Conclusion

Does the data support all intended climatic zones?

Note: Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010

3.2.P.5 Control of Drug Product → 3.2.P.5.2 Analytical Procedures

Are the test methods used the same as in the previously submitted stability information?

If changed: justify and provide validation data.

3.2.P.5 Control of Drug Product → 3.2.P.5.4 Impurities

Are there any new degradation products identified within the newly submitted data?

Threshold: >0.10% per ICH Q3B(R2)

3.2.P.7 Container Closure System

Any changes in the packaging configuration and/or storage of the samples during stability?

[Figure 1: Cross-section of proposed aluminum/aluminum blister pack]

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