A reminder was sent out to stakeholders of the European Medicines Agency (EMA) which pointed out that, independent from the extension of the date for the UK’s withdrawal from the EU (Brexit) to the 31st of October 2019, Marketing Authorisation Holders (MAH’s) should use the remaining time to complete all necessary preparations. This means that by the 1st of January 2020 all batch testing sites must be fully transferred to the remaining 27 EU 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 EMA wrote on their website, “The transfer should be completed quickly and in principle by the end of 2019 at the latest”

If you would like to discuss any specific requirements relating to Brexit readiness and how MIAS Pharma can help you, get in touch with us today at info@miaspharma.com or call us on +353 (1) 846 3605.

Source: https://www.gmp-compliance.org/gmp-news/brexit-industry-should-keep-timelines-for-batch-testing-facilities