Article 7a: Super-grouping of variations

Location:
Chapter I
Source:
Eur-Lex
1.   By way of derogation from Articles 7 and 13d, the holder may submit a single notification of variations to the terms of more than one marketing authorisation referred to in Chapters II, IIa and III owned by the same holder where the same or several minor variations of type IA referred to in Article 8, Article 13a or Article 14 are notified at the same time and fall within one of the cases of super-grouping of variations listed in the guidelines referred to in Article 4(1) (‘super-grouping’).
2.   A single notification as referred to in paragraph 1 shall be made simultaneously to the reference authority and all relevant authorities.