Variations to MRP/DCP marketing authorisations

The Commission Regulation (EC) No 1234/2008 of 24 November 2008 on the assessment of variations to marketing authorisations for medicinal products for human and veterinary use entered into force for medicinal products authorised under the mutual recognition procedure or the decentralised procedure became effective on 1 January 2010.

The Commission Regulation (EU) No. 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products became effective on 2 November, 2012.