In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached, the Medicines and Healthcare Regulatory Agency (MHRA) has now published guidance entitled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal“. Below, we set out the key points arising from that guidance.

Withdrawal Act

The regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. For example, in relation to medicinal products, Directive 2001/83 and Regulation 726/2004, which govern marketing and supply in the EU, are implemented into UK law by the Human Medicines Regulations 2012 (HMR). For medical devices, Directives 93/42 (on medical devices), 98/79 (on in vitro medical devices) and 90/385 (on active implantable medical devices) set out the regulations in the EU, and are implemented in the UK through the Medical Devices Regulations 2002 (MDR). In addition, the new Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro medical devices) will apply from 2020 and 2022, respectively.

In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018 (EUWA), all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.

Continue Reading MHRA guidance on no-deal Brexit

Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how the European Commission has received the White Paper, other than that it represents important progress for focusing the further discussions, we set out below the key points for the supply and manufacture of medicinal products and medical devices after Brexit.

Continue Reading UK Government’s Brexit White Paper

In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health. The results of the study were published earlier this week.

Continue Reading EMA publishes results of study on Brexit preparedness

The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today. The final destination, Amsterdam, does not come as a complete surprise, despite the fact that the key institutions involved in the process, the Commission, the EMA and the Council, have consistently avoided naming preferred locations. As of today, the EMA has 17 months to conclude its move and take up its operations from Amsterdam by the end of March 2019.

The decision to relocate the EMA, although a consequence of the UK’s decision to leave the EU, does not form part of the Brexit negotiations. The procedure leading up to a decision on the relocation of the EMA was proposed by the Presidents of the Commission and the Council and was endorsed at the European Council meeting of 22 June 2017. Member States had up to the end of July 2017 to submit their offers to host the Agency.  Nineteen Member States put in bids.

Continue Reading EMA’s New Home