EMA
- Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated)
- Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 1 , Online, 15:00 - 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023
- Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 2 , Online, 15:00 - 15:30 Amsterdam time (CET), from 22/06/2023 to 22/06/2023
- Electronic product information (ePI) (updated)
Updated version of the eAF v1.26.0.0 (human variation)
An updated version 1.26.0.0 of the human variation eAFs will be available starting with 31 May 2023, 20:00.
A single change has been implemented to address a non-blocking bug. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human).
- It is recommended to use this latest form for new submissions (document properties date 25.05.2023), however you can finalise the existing forms (if any) in the previous version. Please note that there is no version number change and that the release notes are not published for this minor change at this time.
CMDh
- UPDATE - Q&A on variations Clean Version / Tracked Version
- UPDATE - CMS validation checklist in MRP
- UPDATE - CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System Clean Version / Tracked Version
STUDY DATA TECHNICAL CONFORMANCE GUIDE - https://www.fda.gov/media/153632/download
