Brexit: the exemption for quality control testing

In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of the EU rules for batch testing of medicinal products. The EC communication addressed the option that exemptions could be granted by the competent authorities on case by case basis, allowing marketing authorisation holders, for a limited period of time, as a justified case, to rely on quality control testing performed in the United Kingdom under certain conditions.

The Romanian National Agency for Medicines and Medical Devices (NAMMD) published on their website a document implementing the communication by the EC. The Bulgarian Drug Agency have not posted any publications yet but also follow the EU communication. Details regarding the request template are available on CMDh website. The national competent authorities have established dedicated e-mails for this purpose. The mailing list is available here.

The Estonian State Agency of Medicines will also accept UK based companies as testing sites until the end of 2019. They had a website announcement informing the marketing authorisation holders that the application form must be sent to documentation@ravimiamet.ee by 29 March 2019 at the latest. In the subject line should be stated: „Brexit batch release exemption“; for MRP/DCP medicines – the procedure number; and for national marketing authorizations – the name of the product.