Regulatory Questionnaire
EMA List of Questions – Type II Variation (ID001)
Procedure: EMEA/H/C/005432/II/0023 | Response due: 2025-12-11
The Regulatory Questionnaire profile defines a structured, machine-readable format for regulatory
questions. This resource enables automated routing, tracking, and response management while preserving
rich formatting and traceability to the Common Technical Document (CTD) structure.
Participants & Contacts
1.0 Administrative Information
CTD Ref: 1.1 Application Form
ID: 1
1
Is the fee for the Type II variation fully paid and documented?
See EMA
Fee Guidance for payment confirmation requirements.
CTD Ref: 1.1 Application Form
ID: 2
2
Are all required metadata fields in the application form complete?
- Marketing Authorisation Holder
- Product Name (INN)
- Procedure Number
- Submission Date
1.3 Product Information
CTD Ref: 1.3.1 SmPC, Labelling and Package Leaflet
ID: 3
3
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.”
CTD Ref: 1.3.1 SmPC, Labelling and Package Leaflet
ID: 4
4
Is the patient leaflet revised to clarify the extended shelf life?
“Shelf life after first opening: 36 months when stored at 2–8°C”
CTD Ref: 1.3.1 SmPC, Labelling and Package Leaflet
ID: 5
5
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
CTD Ref: 3.2.P.8.1 Stability Summary and Conclusion
ID: 6
6
Are there any new stability studies conducted?
- Include protocol deviations if any.
- Reference: ICH Q1A(R2)
CTD Ref: 3.2.P.8.1 Stability Summary and Conclusion
ID: 7
7
Does the data support all intended climatic zones?
Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010
3.2.P.5 Control of Drug Product
CTD Ref: 3.2.P.5.2 Analytical Procedures
ID: 8
8
Are the test methods used consistent with previous submissions?
If changed: justify and provide validation data per ICH Q2(R1).
CTD Ref: 3.2.P.5.4 Impurities
ID: 9
9
Are there any new degradation products identified?
Threshold: >0.10% per ICH Q3B(R2)
3.2.P.7 Container Closure System
CTD Ref: 3.2.P.7 Container Closure
ID: 10
10
Any changes in the packaging configuration during stability?
[Figure 1: Cross-section of proposed aluminum/aluminum blister pack]
| Original |
New |
| PVC/PVDC Blister |
Alu/Alu Blister |