Q&A Document on Variations Regulation published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has published a set of Q&As on Variations according to Commission Regulation (EC) 1234/2008. Altogether 23 frequently asked questions are grouped into the following categories:

1. General questions like for example "What is the definition of a MAH?"

2. Questions relating to the submission of variations like for example "Is it necessary to submit variation applications to all concerned member states even if they are not concerned by the specific change"
Answer: "Yes, the applications have to be submitted to all concerned member states."

3. Questions relating to the Classification of a variation like "How to apply for the deletion of more than one manufacturing site?"
Answer: "In case more than one manufacturer in one MA has to be deleted one single Type IA notification (grouped application) for all manufacturing sites has to be submitted…"

4. Questions relating to grouping and worksharing like "Can the same variation for more than one marketing authorisation be submitted on one application form?"
Answer: "Yes, in case of worksharing applications and type IA notifications for several MRP/DCP marketing authorisations one single application form is to be submitted for all marketing authorisations of the same holder concerned…."

5. Questions regarding the approval and implementation of variations as for example "What is meant by "implementation" for Type IA variations?"

The document can be found here.

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

Compiled by Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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