UK – MHRA responds to consultation on Brexit no-deal proposals

In advance of the UK leaving the European Union (EU) on 29 March 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has released a statement detailing its preparations for the event of a no-deal Brexit scenario.

There is ongoing concern that a no-deal Brexit may limit the availability of medicines in the UK, but pharmaceutical companies are “doing everything in their power” to minimise disruption to the supply of medicines should the no-deal scenario become a reality.

Since the outcome of the EU referendum, the MHRA said it has been working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK in the case of all eventualities.

The updated guidance outlines the UK’s proposed arrangements for regulation if a no-deal scenario occurs, including proposals such as automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process also known as ‘grandfathering’.

It also proposes to give free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs), and would give a period until the end of 2021 to amend packaging and leaflets for a product already on the market.

For medical devices, the key arrangement proposals include the expansion of the MHRA’s registration system to all classes of medical device, and for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market…