EMA is encouraging marketing authorisation holders (MAHs) 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.

In order to help MAHs ensure their Type I variations are complete and correct before submitting them to the Agency, MAHs should use the pre-notification checklist before submission of any PDF iconType IA  or PDF iconType IB variation and to follow the regulatory and procedural guidance on Type IAsType IBs and the specific PDF iconguidance on variations related to the submission of Brexit-related changes .

To support the identification and tracking of Brexit-related eCTD submissions, applicants should ensure that the Brexit box is ticked when eSubmission web UI is used (.xml delivery file created).

Posted on the EMA website on 26 February 2019