Regulatory information - EMA encourages companies to submit quality type-I variations for 2013 by end of November

14 October 2013

The European Medicines Agency (EMA) is advising marketing-authorisation holders to submit any quality type-IA_IN and type-IA variations for 2013 by Friday 29 November wherever possible. This will enable the Agency to acknowledge the validity of the submissions before the Agency's closure between 24 December 2013 and 2 January 2014 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing-authorisation holders intending to submit quality type-IB variations in December 2013 should liaise with the EMA prior to submission.

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 the 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.