Brexit: Industry should keep Timelines for Batch Testing Facilities

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

In a reminder sent out to stakeholders the European Medicines Agency (EMA) points out that - independent from the extension of the date for the UK's withdrawal from the EU ('Brexit') to 31 October 2019 - Marketing Authorisation Holders (MAHs) should use the remaining time to complete all necessary preparations. This means that by 1 January 2020 all batch testing sites must be fully transferred to the remaining EU27 Member States and/or EEA countries. Also the necessary regulatory submissions must be completed by then. This includes MAHs who have the permission to perform quality control testing in the UK even after Brexit. "The transfer should be completed quickly and in principle by the end of 2019 at the latest", EMA writes on their website with Brexit related guidance documents. Companies should check this page regularly.