According to Commission Regulation (EC) No 1234/2008 regarding the examination of marketing authorisations for medicinal products for human use and veterinary medicinal products, detailed provisions on the variation procedure and on the category of variations have to be set in separate guidelines. Those detailed provisions are laid down in the two guidelines on the handling of procedure and various variations categories - published "as communication of the Commission" in the Official Journal of the EU respectively in December 2009 and January 2010.
Now, the EU Commission has combined them and released them on 16 May 2013 in a document entitled "Guidelines on the details 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".
This "Guidelines" document takes into consideration updates with regard to amendments to the variations as well as the fact that according to Commission Variations Regulation (EU) No 712/2012 - as of 4 August 2013 - variations applications submitted by national competent authorities have to be also proceeded according to the European Variations procedure. Further provisions of Regulation (EU) No 712/2012 have also been considered in the final "Guidelines".
Marketing Authorisation Holders (MAH) who submit a variations application now only have to consider one document.
The Commission has announced that the "Guidelines" will be published together with the entry into force of the provisions from the Regulations 1234/2008 and 712/2012 in the EU Official Journal. With the pre-publication of the document on the Commission Website, the Commission would like to give MAHs the opportunity to get familiar with the new provisions and prepare eventual corrections to variations applications.