With the United Kingdom (UK) leaving the European Union (EU) on 29th March 2019, the Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance which outlines the UK’s proposed arrangements for medicine, medical device and clinical trial regulation if the UK leaves the EU with no deal.
The key arrangements for medicines are as follows:
- “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.”
The key arrangements for medical devices 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.”
The key arrangements for clinical trials 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.”
To read more on the MHRA’s response to the consultation on EU exit no-deal legislative proposals, please click here.
Further guidance on the regulation of medicines, medical devices and clinical trials is available here.