COMMISSION REGULATION (EC) No 1234/2008 of 24 November
24 nov. 2008 Chapter III shall apply only to variations to the terms of ... classification laid down in Annex II shall apply. 2. A variation which is not ...
Commission Regulation (EU) No 712/2012 of 3 August 2012
3 août 2012 variations to the terms of marketing authorisations ... cases listed in Annex III a single submission may cover all such variations ...
BEST PRACTICE GUIDE for Grouping of Variations
13d in connection with Annex III of the Variation. Regulation allow the combination of several changes into one single application. However this guidance only
NOV BPG on grouping of variations
European variations for medicinal products for human use
to Marketing Authorisations include Type IA Type IAIN
WP European variations for medicinal products for human use February ?x
European variations for medicinal products for human use
to Marketing Authorisations include Type IA Type IAIN
WP European variations for medicinal products for human use February ?x
B COMMISSION REGULATION (EC) No 1234/2008 of 24 November
2 nov. 2012 cation laid down in Annex II shall apply. ▽M1. 2. A variation which is not an extension and whose classification is.
European variations for medicinal products for human use
to Marketing Authorisations include Type IA Type IAIN
WP European variations for medicinal products for human use February
Guidelines on the details of the various categories of variations on
2 août 2013 Outcome of Type II variations assessment in centralised procedure . ... The Variations Regulation and the Annex to these guidelines set.
Guideline on the operation of the procedures laid down in Chapters
of grouped variations which are not listed in Annex III of the variations regulation together with a justification for grouping.
procedural guideline adopted
C 223 Official Journal
2 août 2013 Outcome of Type II variations assessment in centralised procedure . ... The Variations Regulation and the Annex to these guidelines set.
- condition 5 of annex iii of the variation regulation
- allowed groupings are listed in annex iii of the variations regulation
- annex 3 variation regulation