The EMA has updated its practical guidance for pharmaceutical companies for procedures related to Brexit
From 30th March 2019, when the United Kingdom’s (U.K.) is expected to withdraw from the European Union (EU), all EU law will no longer apply to the U.K. The European Medicines Agency (EMA) and the European Commission have therefore published additional practical guidance to help pharmaceutical companies legally prepare for this transition. This guidance will aid pharmaceutical companies when they apply for changes in their marketing authorisation, allowing them to maintain marketing rights within the European Economic Area following Brexit. (December 01, 2017)
The guidance covers significant areas that will be affected post Brexit including effects on manufacturing, the fees involved in transferring market authorisation, handling regulatory procedures, transferring orphan designation, and changes to Pharmacovigilance personnel.
According to a question and document, there are many legal changes that companies based in the U.K., or market holders in the U.K. will have to make. This includes transferring its marketing authorisation and orphan drug designation to a holder established in the Union (EEA), and the “Qualified Person for Pharmacovigilance”.
U.K. based companies will no longer benefit from the incentives associated with the MUMS (Minor Use Minor Species/limited market) status.
All medicines manufactured in the U.K. will be considered imported active substances and medical products when moved to the EU, and will therefore need to specify an authorised importer established in the EU.