Brexit: the exemption for quality control testing

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.