Posted by Michael Wonder on 26 Feb 2019
Procedural update on submission of Type I variations to EMA in March, April and May 2019
26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations in March 2019 to file these variations as early as possible during the month.
This will enable EMA to process the submissions before 29 March so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before this date.
Type I variations are minor changes to the marketing authorisation of medicines for human and veterinary use. Brexit-related changes to be submitted as Type I variations include changes to sites responsible for batch release, physical importation, batch control testing of finished product and update of CE marking documentation for medical devices co-packaged with medicinal products.
The Agency foresees a significant increase (over 50%) in the number of Type I variations in the next three months as companies submit pending Brexit-related changes to their marketing authorisations.
