The European Medicines Agency (EMA) on Tuesday outlined the requirements that companies should follow when they apply for changes to their marketing authorization to allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU.

The guidance, which comes in the form of nine questions and answers and anticipates that the UK will leave the EU as of 30 March 2019, was released on the same day that EU pharmaceutical industry groups called on Brexit negotiators to establish a transition period whereby all relevant EU authorities can adapt to changes resulting from the UK’s exit.

Marketing authorization holders (MAHs) established in the UK, according to the guidance, will need to be replaced with a MAH established in one of the remaining countries of the EEA, which requires an application for a transfer of a marketing authorization.

In addition, a company’s qualified person for pharmacovigilance (QPPV) must reside and carry out his/her tasks in an EEA member state, and the pharmacovigilance master file (PSMF) also must be located within EEA, the guidance notes.

Industry groups including EFPIA, ABPI and Medicines for Europe highlighted some of the challenges of the transition: "For our sector, Brexit represents a challenge in several areas, notably regulatory procedures, quality testing of medicines, supply chain, trade, and intellectual property. For example, medicines companies may need to submit applications for the transfer of marketing authorisation for many products, move batch release sites and duplicate quality testing for products or move personnel into either jurisdiction. This will take a significant amount of time and will result in capacity issues which cannot be resolved before March 2019."

Guidance

EFPIA

United Kingdom’s withdrawal from the European Union ('Brexit')