EMA List of Questions

ID001 – Shelf-life extension Type II Variation • Due 2025-12-11

The Regulatory Questionnaire profile defines a structured, machine-readable format for regulatory questions issued by a health authority during the review of a regulatory submission. This resource enables automated routing, tracking, and response management while preserving rich formatting and traceability to the Common Technical Document (CTD) structure.

Participants & Contacts/div>

ISSUING AUTHORITY

European Medicines Agency
Scientific and Regulatory Management Division
EMA Amsterdam HQ

RECIPIENT MAH

SynthPharma AG
Global Regulatory Affairs Group
Basel, Switzerland

Module 1: Administrative Information

CTD Ref: 1.1 Application Form ID: Q-ADMIN-01

Is the variation fee fully paid and documented?

Confirmation of payment received by EMA Finance on Dec 20, 2024.

Module 3.2.P.7: Container Closure System

CTD Ref: 3.2.P.7 Container Closure ID: Q-PKG-10

Any changes in the packaging configuration during stability?

[Draft Figure: Alu/Alu Blister Cross-section]

Original Pack	Proposed Pack
PVC/PVDC Blister	Alu/Alu Blister

Module 3: Quality - Stability

CTD Ref: 3.2.P.8.1 Stability Summary ID: Q-STAB-06

Are there any new stability studies conducted or only additional timepoints?

Reference: ICH Q1A(R2). Response provided on Dec 15, 2024.

CTD Ref: 3.2.P.8.1 Stability Summary ID: Q-STAB-07

Does the data support all intended climatic zones?

Confirm coverage for Zone IVb (30°C/75% RH) per WHO TRS 1010. Provide summary for all tested climatic conditions.