The European Medicines Agency (EMA) is encouraging Marketing Authorisation Holders (MAHs) who intend to submit Brexit-related Type IA and Type IB variations in March 2019, to submit these variations as soon as possible during the month. This will ensure that the EMA can process the submissions before 29th March, so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before the United Kingdom (UK) leaves the European Union (EU).
Changes caused by Brexit that are to be submitted as Type I variations include batch control testing of finished product, batch release, physical importation and CE marking documentation update for medical devices co-packages with medicinal products.
MAHs are advised to use the pre-notification checklist before submitting any Type 1A or Type 1B variation, and to follow the regulatory and procedural guidance on Type IAs, Type IBs and the specific guidance on variations related to submission of changes due to Brexit. In order to support the identification and tracking of Brexit-related eCTD submissions, the EMA have requested that applicants ensure that the Brexit box is ticked when eSubmission web UI is used. Furthermore, the EMA has stated that MAHs should not include editorial changes as part of Type IA and Type IB submissions during the next three months.
The EMA have stated that the majority of MAHs have shared their plans for the submission of Brexit-related post-authorisation changes with the EMA. However, if you need to report any changes to your plans, an email should be sent to firstname.lastname@example.org, ensuring the product lead for the product and the product mailbox are copied into the email.
To read more about the EMA procedural update on submission of Type 1 variations to EMA in March, April and May 2019, and to read Brexit-related guidance, please click here.