This document presents the official response to the regulatory questions issued by the health authority. It provides detailed evidence, justifications, and technical data in a structured format that maintains full traceability to the original request and the CTD structure.
Global Regulatory Strategy
Basel, Switzerland
john.doe@synthpharma.example
Scientific and Regulatory Management
Human Medicines Evaluation Division
jane.doe@ema.europa.eu
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:
- MAH: SynthPharma AG
- Product: ExampleDrug 10 mg Tablets
- Procedure: EMEA/H/C/005432/II/0023
- Submission Date: 2025-06-25
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.
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.
The submission includes both extended long-term data (36 months) for primary batches and new studies for pilot-scale batches in Alu/Alu packaging. No protocol deviations occurred.
Yes, the data supports all ICH climatic zones, including Zone IVb (30°C/75% RH). All batches remain within specification.
Yes, the packaging was changed from PVC/PVDC to Alu/Alu. New stability studies were initiated and stored under standard conditions.
Figure 1: Cross-section of new Alu/Alu blister showing foil thickness and lidding layers.
| Parameter | Original | New |
|---|---|---|
| Material | PVC/PVDC | Alu/Alu |
| Storage | 25°C/60% RH | Unchanged |