Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018

News 26/10/2018

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IAIN and type IA variations for 2018 no later than Friday 30 November 2018. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 21 December 2018 and 2 January 2019 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders planning to report Brexit-related Type IA/IAINvariations in December 2018 will receive the acknowledgment of the validity of the submissions within 30 days as per the usual procedure.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 7 December 2018 for a start of procedure in 2018. For submissions received on or after 10 December 2018, the procedure may not start until January 2019.

For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: iaquery@ema.europa.eu or ibquery@ema.europa.eu. For veterinary medicines, the following e-mail address should be used: 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 IAINvariations 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 EMA before implementing the change.

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