Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021

29 October 2021

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IA_IN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23 December 2021 and 3 January 2022 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3 December 2021 for a start of procedure in 2021. For submissions received on or after 6 December 2021, the procedure may not start until January 2022.

For veterinary medicines, marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by Monday 15 November 2021 for a start of procedure in 2021. For submissions received on or after 16 November 2021, the procedure will not start until January 2022.

EMA is advising marketing authorisation holders for veterinary medicines to submit type IB and type IA variations for assessment under Commission Regulation (EC) No 1234/2008 no later than 20 January 2022, to ensure that the validation is completed on or before 27 January 2022.  Any type IB variation which has not been validated by 27 January 2022 may need to be resubmitted as a variation requiring assessment under Regulation (EU) 2019/6. For guidance on variations requiring assessment and variations not requiring assessment, please see the latest guidance available on the Agency website.

For procedural or regulatory queries related to these procedures, marketing authorisation holders for human medicines can raise a ticket via the EMA Service Desk, using the Question option. The Type of question to be selected is “Post-authorisation queries”, followed by sub-option “Variation IA” or “Variation IB A&B scopes” or “Variation IB C scopes”. Marketing authorisation holders for veterinary medicines are advised to contact the veterinary applications team in advance of an upcoming submission at the following email address: [e-mail].

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 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.