Implementation of the Variations Regulation - EU

Summary and contributions from stakeholders to the public consultation paper for the preparation of guidelines on the details of the various categories of variations.   
Directorate General for Enterprise and Industry consulted stakeholders on a contribution to the preparation of the guidelines on the details of the various categories of variations following Article 4(1)(a) 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. A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found here.