20 Feb Impact of Brexit: BfArM Is Preparing
Following the withdrawal of Great Britain from the European Union (“Brexit”), the United Kingdom’s licensing authority is no longer available for EU approval procedures and for regulatory pharmacovigilance activities. So far Great Britain played an important role. While it may depend on the outcome of the negotiations, what the implications of Brexit for the UK and the EU Member States actually are, there are very significant implications for the pharmaceutical sector. This also applies to the regulatory authorities in the Member States: services currently provided by the UK licensing authority must be taken over by the other EU licensing authorities and their experts.
As stated in a recent communication from the Federal Institute for Drugs and Medical Devices (BfArM), they are preparing to take over future tasks resulting from Brexit. The communication states:
“It is the primary goal of the BfArM to maintain the availability of medicines for the patients during and after the negotiations. The BfArM will continue to reinforce its role in the European network, increase its capacity to take on additional centralized and decentralized (MRP / DCP) approval and follow-up procedures, and increase its involvement in clinical trials and inspections as well as pharmacovigilance, in order to address bottlenecks in the European network European regulatory network in the best possible way. ”
The BfArM understands itself as “full-service-provider”, i.e. the additional capacity is expected to be created for all additional tasks and for all indication areas. This includes capacity for new procedures, and the BfArM is also available as a reference member state (RMS) for the completed mutual recognition procedures and decentralized procedures for which the United Kingdom holds the RMS function. In the case of an “RMS switch” the BfArM strongly recommends to tackle this as soon as possible in order to avoid a takeover delay shortly before Brexit.
In the future, the BfArM intends to publish its own FAQs from any questions it has received, if the issues addressed are not already described by the Commission / EMA or CMDh.