EC public consultation on MA variations
The European Commission has published a public consultation on draft guidelines under the new Variations Regulation (EC) no 1234/ 2008. This accompanies a March consultation on draft guidelines about the operation of the new Regulation, which applies from January 1, 2010, to variations to marketing authorizations granted via the mutual recognition, decentralized and centralized procedures.
The Commission's Directorate General for Enterprise and Industry explained that the change clarifies the classification of variations into the following categories: Type IA, Type IB and Type II and provides further details, where appropriate, on the scientific requirements and documentation to be submitted for specific variations.
The DG for Enterprise and Industry will use the feedback to prepare guidelines for adoption by the Commission as part of the "Better Regulation" of pharmaceuticals agenda. The Commission's goal is ensuring that the variations framework will become "simpler, clearer and more flexible, while ensuring a high level of protection of public health," the consultation document states.
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