Regulatory information - EMA encourages companies to submit type I variations and transfer of marketing authorisation applications for 2015 by end of November

24 November 2015

EMA to check validity of submissions by end 2015

The European Medicines Agency (EMA) is advising marketing-authorisation holders to submit any transfer of marketing authorisation applications and type IA_IN and type IA variations for 2015 by Monday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency's closure between 24 December 2015 and 3 January 2016 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders are also advised to submit any type IB variations or groupings of type IBs and type IAs for a start of procedure in 2015 by 11 December 2015. For submissions received on 14 December or after this date, the procedure may not start until January 2016.

For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: [e-mail] , [e-mail] or [e-mail]. For veterinary medicines, the following e-mail address should be used: [e-mail].

A transfer of marketing authorisation is the procedure by which the marketing authorisation is transferred from the current marketing authorisation holder to a new marketing authorisation holder which is a different person/legal entity. It is a 30-calendar day procedure with no possibility for clock stops.

Type I variations are minor changes to the marketing authorisation of a medicine.

Type IA_IN and IA variations have no impact on the quality, safety or efficacy of the medicine. Type IA_IN variations must be notified to the national competent authority or EMA immediately following implementation, in order to ensure the continuous supervision of the medicine. Type IA variations do not require immediate notification and should be notified to the national competent authority or the EMA within 12 months of implementation, or earlier in certain cases.

Type IB variations must be notified to the national competent authority or the EMA before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the marketing authorisation holder must wait for a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or the EMA before implementing the change.