Brexit update - MHRA announcement

The UK is leaving the EU on 29 March 2019. We remain focused on delivering the deal that we have negotiated with the EU. However, as a responsible government, it is right that we continue to prepare for all scenarios and provide information so that other organisations can do the same.

Following our consultation on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario, we have today issued updated guidance setting out the UK’s proposed arrangements for regulation if we leave the EU on 29 March 2019 with no deal.

For medicines, the key arrangements include:

• automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’

• targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion

• a full accelerated assessment for new active substances

• free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs)

• a period until the end of 2021 to amend packaging and leaflets for a product already on the market

• allowing the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country

• continuing to recognise prescriptions issued in EU or EEA countries.

For medical devices, the key arrangements include:

• 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

• the expansion of the MHRA’s registration system to all classes of medical device.

For clinical trials, the key arrangements include:

• continuing to recognise existing approvals so there will be no need to re-apply

• requiring the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list which would initially include EU or EEA countries

• aligning, where possible, with the EU Clinical Trials Regulation when it applies.

Further detailed guidance is available in the Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal.

Dr Ian Hudson, Chief Executive Officer at the MHRA said

The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles, that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health.

The responses to our consultation have helped us prepare a robust plan to make sure our regulatory processes for medicines, clinical trials and medical devices are fit for purpose on exit day.

We are committed to giving businesses and individuals as much certainty as possible, as soon as possible to make sure the UK continues to be at the forefront of regulatory innovation and processes.

These proposals are still subject to parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.

Further guidance

Further updated information can be viewed on the gov.uk website.

Further update: 27/02/19

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However, the government must prepare for every eventuality, including a no deal scenario.

Today we have published guidance that sets out how medical devices will be regulated in the UK in a no deal scenario. References in this guidance to events happening “after” or “from” 29 March 2019 are to be read as references to events which happen at or after 11pm on the 29 March 2019.

If there is no deal with the EU concerning the terms of the UK’s withdrawal from the EU, the UK’s current participation in the European regulatory network for medical devices would end, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the responsibilities for the UK market currently undertaken through the EU system.

This guidance provides further detail on how the UK system would operate, including for:

• getting your device certified
• CE marking your device
• registering your device with the MHRA

These proposals are still subject to parliamentary approval of the changes to the relevant statutory instruments that are required to bring these proposals into law.

All current information from MHRA relating to a possible no deal scenario can be found on our website. The Department of Health and Social Care has a similar page with sector-wide guidance, including contingency plans for a no-deal Brexit.

If you have any queries, please email engagement@mhra.gov.uk.