BEST PRACTICE GUIDE for Grouping of Variations
also fall within one of the cases listed in Annex III of the Regulation or
NOV BPG on grouping of variations
Examples of Groupings for Variations
9 oct. 2014 approved by the MHRA acceptance of the proposed grouping requires ... described in Annex III of the Regulation “All variations in the group.
Examples of groupings
COMMISSION REGULATION (EC) No 1234/2008 of 24 November
24 nov. 2008 Grouping of variations should nevertheless be allowed ... a variation which is listed in Annex I and fulfils the.
Commission Regulation (EU) No 712/2012 of 3 August 2012
3 août 2012 Grouping of several variations in a single submission is possible in some cases. ... cases listed in Annex III a single submission may.
European Medicines Agency post-authorisation procedural advice
20 juin 2022 ... variations (e.g. Type IB Type II
european medicines agency post authorisation procedural advice users centralised procedure en
B COMMISSION REGULATION (EC) No 1234/2008 of 24 November
2 nov. 2012 authorisation is allowed to implement a given variation as such ... fall within one of the cases listed in Annex III a single submission.
Post-Authorisation Procedural Advice
20 janv. 2010 This Post-Authorisation procedural advice on Variation Regulation (EC) No ... Allowed groupings are listed in Annex III of the Variations ...
en
WHY IS NOW THE RIGHT TIME TO MODERNISE THE EU
After over 10 years of experience of the Variations Regulation Fine tune the concept for grouping and work-sharing to allow for optimal benefits to the ...
ESE Medicine for Europe AESGP Variation WEB
National FAQ on variations - 1/10/2015
1 oct. 2015 List with examples of accepted and non-accepted groupings ... of a combination of IA/IB/II variations that is described in annex III of.
National FAQ Variations EN
Guidelines on the details of the various categories of variations on
2 août 2013 corresponds to one of the cases listed in Annex III of the. Variations Regulation or when this has been agreed previously.