CMDh: Update of the Q&A List Variations

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.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.