Grouping
Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping?
Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective submission. This is marked by an “S” in the procedure number. In these cases, the tickbox “grouping of variations” in the application form does not have to be marked.
A grouping should be marked in the application form in cases where several changes are grouped.
It is intended to adapt the announcement of the BfArM of 12 July 2013 accordingly in the next update.
Is it allowed to group minor notifications of type IA category A + B + C in one application without any relation to each other?
All minor notifications of type IA and type IAIN may be grouped in one application without any relation to each other, if the group includes only type IA and type IAIN.