03 May 2017 - Authored by:Rafi Allos
On 2 May 2017, the European Commission (EC) and the European Medicines Agency (EMA) published a notice to marketing authorisation (MA) holders of centrally authorised medicines reminding them of their legal obligations in preparation for Brexit. The notice reminds its addressees that EU law requires that MA holders are established in the EU or EEA and that some activities in respect of medicinal products authorised in the EU/EEA must be performed in the EU and EEA such as pharmacovigilance and batch release.
The notice states that the EC and EMA “expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework”. As such MA holders are advised to ensure that they have the necessary processes in place to effect relevant changes to the terms of their MAs in good time for 30 March 2019 when the UK’s withdrawal from the EU is expected to become effective.
The notice also states that the EMA will be publishing a series of Q&As in relation to the MA holders’ legal obligations and that it will be expanding its page on Brexit. As regards products authorised under the decentralised or mutual recognition procedures, MA holders are informed that guidance in relation to preparing for Brexit will be available from the Coordination Groups websites: human medicines and veterinary medicines.
This notice comes after the EMA held a meeting with the Heads of Medicines Agencies on 27 April 2017 to start discussing how the work related to the evaluation and monitoring of medicines will be shared between member states in view of Brexit. A press release was issued by the EMA regarding the meeting.
As regards the location of the EMA, the European Council approved Brexit negotiating guidelines on 29 April 2017 stating the following:
15. While the future location of the seats of EU agencies and facilities located in the United Kingdom is a matter for the 27 Member States to settle rapidly, arrangements should be found to facilitate their transfer.
Further information setting out the criteria to determine the location of the EMA following Brexit is expected to be released by the EU institutions and/or member states in due course and will assist in deciding which of the many member states that have pitched to host the EMA will be successful.