CMDh: Update of the Q&A List Variations
Recommendation
Wednesday, 21 May 2025 10.00 - 16.00 h
How to use and prepare an MA with a CEP 2.0
Register now for ECA's GMP Newsletter
A revision of the "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" was prepared in May 2020 and published on the HMA (Heads of Medicines Agencies) website. This document lists and answers general questions regarding variation procedures and their submissions for human and veterinary medicinal products.
A new question and its answer have been added in section 1.9 "How do I notify an update of the contact details of the qualified person for pharmacovigilance (QPPV) specified in the application form / Part IA for MRP/DCP or purely nationally authorised products?"
Here, you will find both versions of the Q&A document: with track changes and the final version.
Related GMP News
16.04.2025EMA: Revised IRIS Documents
09.04.2025Centralised Procedures: Q&As Updated
12.03.2025CMDh/HMA: Guidance Documents on Variation Notifications Updated
11.03.2025EMA: Renewal of Q&A Document for "Centralized Procedures"
11.03.2025Centralised Procedures: Q&A Documents also Updated for Biosimilars
29.01.2025CMDh/HMA: Updated Guidance Documents on Variation Notifications