Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.
While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.
In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.
Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.
The text in italics is part of the European Medicines Agency (EMA) press release issued today that informs that companies are stepping up and that the focus is now on 39 centrally authorised Medicines down from 108. The Press Release is here.
Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.
I posted several times regarding EU Notices and Notices from EU regulatory agencies. These remind that the UK will be a third country (as respects the EU) on exit at 12pm CET 29th March 2019. If you have not already done so, please read these Notices.
Any Transition Period that is agreed is in the context of the EU-UK Withdrawal Treaty, and will continue certain EU arrangements only.
One of the aspects is UK membership of EU regulatory agencies (third countries are not members of EU regulatory agencies).
On 11th April 2018, the European Medicines Agency (EMA) confirmed that the EU27 member states and the EMA had completed the task of redistribution of the UK portfolio of centrally authorised medicine and veterinary products. The UK will not be a member of the EMA on its exit. Arrangements were already in place to relocate the EMA (from the UK) to an EU27 member state.
Please read the information that is published about this redistribution here.
On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.
The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :
(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),
(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,
(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,
(4) active substances manufactured in the UK will be considered imported active substances,
(5) medicinal products manufactured in the UK will be considered imported medicinal products,
(6) batch release sites (for certification) must be located in the EEA.