

Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August 2013. In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the 'reference authority'. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure, the Agency will be the 'reference authority'. In order to avoid duplication of work in the evaluation of such variations, a worksharing procedure has been established under which one authority (the 'reference authority'), chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities. In such cases, the review of the type-IA or -IA IN variation will be performed as part of the worksharing procedure. However, it is possible to include a group of type-IA and -IA IN variations with a type-IB or a type-II variation, which is submitted for a worksharing procedure. Type-II variations: extension applicationsĪrticle 20 of Commission Regulation (EC) N° 1234/2008 (the ' Variations Regulation') sets-out the possibility for a MAH to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same MAH in one application.Īpplicants belonging to the same mother company or group of companies and applicants having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as 'the same MAH' 1.Įxtensions are excluded from worksharing.īased on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisations, this is considered as a 'group' of variations and not a ' worksharing' procedure.Submitting a post-authorisation application.

Post-authorisation efficacy studies (PAES).

