No-deal Brexit plan

BRITAIN’S Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance setting out proposed arrangements for regulation of medicines in the event of a “nodeal” Brexit.

The UK is leaving the European Union on 29 Mar 2019, with the government continuing to focus on delivering the deal which has been negotiated with the EU.

However preparations for all scenarios are also under way, and in the event a deal is not finalised the new guidance specifies a range of key arrangements.

These include automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations, a process known as “grandfathering”.

The MHRA will also undertake targeted assessment of new applications for products containing new active substances or biosimilars which have received a positive outcome from the European Medicines Agency.

Free scientific advice will be provided for UK-based small and medium enterprises, including for orphan medicines, and the plan also provides for a period until the end of 2021 to amend packaging and leaflets for items already on the market in Britain.

Prescriptions issued in EU countries will continue to be recognised, and parallel imports will be allowed for products holding an EU marketing authorisation.