Tag Archives: Variation applications

Be prepared for your changes!

The European Commission published updated procedural and classification guidance regarding variations on 16 May 2013.

Details are provided of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures.

The Guidelines replace existing guidelines with an effective date of 4 August 2013 and apply to variations to centralised and national marketing authorisations.