Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November
EMA to check validity of submissions by end 2016
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency's closure between 23 December 2016 and 2 January 2017 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.
Marketing authorisation holders are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations for a start of procedure in 2016 by 13 December 2016. For submissions received on or after 14 December 2016, the procedure may not start until January 2017.
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 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.
For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: firstname.lastname@example.org or email@example.com. For veterinary medicines, the following e-mail address should be used: firstname.lastname@example.org.