Implementation of the Variations Regulation: 2 Public Consultation Papers published

As part of the implementation of the Variations Regulation, EMEA has published 2 Public Consultation Papers: one on the details of the various categories of variations and one on the operation of the variation procedures.

Article 4(1)(a) and 4(1)(b) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medical products for human use and veterinary medicinal products establishes that the Commission  shall, after consulting the Member States, the Agency and interested parties, draw up guidelines on the details of the various categories of variations and on the operation of the procedures laid down in Chapters II, III and IV of the Regulation.

With this public consultation, Directorate General for Enterprise and Industry intends to consult all stakeholders on a contribution to the preparation of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMEA and it will form the basis for the preparation of the Commission guidelines.

The two Public Consultation Papers can be found here: categories of variations, operation of the variation procedures

Summarised by:
Wolfgang Schmitt
O the behalf of the European Compliance Academy (ECA)

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