Regulatory update - EMA encourages companies to submit type I variations for 2020 by end of November

29 October 2020

EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2020 no later than Monday 30 November 2020. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 24 December 2020 and 4 January 2021 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/IAIN variations in December 2020 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 4 December 2020 for a start of procedure in 2020. For submissions received on or after 7 December 2020, the procedure may not start until January 2021.

For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: [e-mail] or [e-mail].

For veterinary medicines, marketing authorisation holders are advised to contact the veterinary applications team in advance of an upcoming submission at the following e-mail address: [e-mail].

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.