CMDh: Update of the Q&A List Variations
Recommendation
5/6 December 2023
How to Achieve Regulatory Compliance for APIs, Biological Substances and Drug Products
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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.
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