Regulatory update - EMA encourages companies to submit quality type I variations for 2014 by end of November

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24/10/2014

Regulatory update - EMA encourages companies to submit quality type I variations for 2014 by end of November

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 IBs and type IAs in December 2014 should liaise with the EMA prior to submission. An email should be sent to: IBquery@ema.europa.eu indicating in the subject line: “Type IB December Submission” and mentioning in the body of the email the name of the product, the intended submission date and the scope(s) to be applied according to the Classification guideline.

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 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.

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