Are you preparing for Brexit? Considerations for MAHs

On 2nd May 2017, the European Medicines Agency (EMA) published a joint statement with the European Commission (EC)outlining the areas of consideration for marketing authorisation holders (MAH) of centralised products in relation to the impact of Brexit. The Coordination group for Mutual recognition and Decentralised procedures – human (CMDh) has also published a corresponding statement providing similar information aimed at MAHs of nationally authorised products and setting out the same expectations.

By law, the MAH of centralised products must be registered in an EU or EEA member state – once the UK leaves the EU in March 2019 any MAHs registered in the UK will cease to comply with this law. Similarly, in relation to manufacturing and batch release, performing these operations in the UK once Brexit is implemented will mean the product is not in compliance with the requirements of EU law and product will either need to have primary batch release performed in an EU member state, or will need to be re-released upon import to the EU.

In relation to pharmacovigilance, the position of the EU QPPV needs to be considered, since the EU QPPV by definition must reside and carry out their duties in an EU member state.

The EMA and EC are encouraging companies to consider these requirements in light of Brexit now, so as to ensure that once the UK leaves the EU there is no impact on the continued supply of drugs to patients. In practical terms, the EMA/EC statement suggests that companies perform a thorough review of the aforementioned details in relation to their centrally authorised products, and prepares to make the required changes to registered details and processes if necessary in a timely manner. The EMA/EC statement advises MAHs to consider the procedural duration of any required variations and to plan these accordingly.

Of course, how the relationship between the UK and the EU will work has not been defined yet, and therefore similarly the future relationship between the MHRA and the EMA cannot be established. However, the EMA is currently discussing potential changes to their workload in order to be prepared to cover any gaps that will be left if the MHRA has to withdraw entirely from their contributions to the centralised procedure activities.

Both the EMA and the CMDh will be providing in the future a series of Q&As for MAHs, in order to support them through Brexit and ensure a minimal impact upon patients. The EMA dedicated website where further information on the preparations for Brexit, future location of the EMA and additional practical information for MAHs can be found can be reached by clicking here.

The CMDh page for the Brexit can be found here.

The statement by the EMA/EC and the corresponding CMDh statement can be found at the following links:

EMA/EC statement

CMDh statement