EMA to check validity of submissions by end 2014
The European Medicines Agency (EMA) is advising marketing-authorisation holders to submit any type-IAIN and type-IA variations for 2014 by Friday 28 November wherever possible.
This will enable the Agency to acknowledge the validity of the submissions before the Agency's closure between 24 December 2014 and 2 January 2015 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
Marketing-authorisation holders intending to submit type-IB variations or groupings of type-IB and type-IA variations for human medicines in December 2014 should liaise with EMA prior to submission. They should send an e-mail to ibquery@ema.europa.eu indicating 'Type IB December submission' in the subject line and mentioning the name of the product, the intended submission date and the scopes to be applied according to the Classification guideline in the body of the e-mail.
Similarly, marketing-authorisation holders for veterinary medicines should send an e-mail to vet.applications@ema.europa.eu.
Type-I variations are minor changes to the marketing authorisation of a medicine.
Type-IAIN and -IA variations have no impact on the quality, safety or efficacy of the medicine. Type-IAIN 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 EMA within 12 months of implementation, or earlier in certain cases.
Type-IB variations must be notified to the national competent authority or 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 EMA before implementing the change.