On 18 February 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), updated its guidance on medicine licensing post-Brexit “Apply for a licence to market a medicine in the UK”. The update provides further clarity on the UK’s status in the licensing process now that Brexit has taken place.

The updated guidance makes it clear that whilst the UK can continue to participate in some of the licensing avenues available to the EU Member States for marketing medicines across the EU and UK (decentralised and mutual recognition schemes in particular), it cannot act as the lead in these application – the Reference Member State (RMS).

This change is one of many for the EU medicine licensing regime which go to the UK’s new status as a non-Member State.

The updated guidance does outline what is still possible for UK entities post-Brexit under the EU medicine licensing regime, on the basis the EU will continue to recognise these UK-based actions:

  • batch release testing and qualified person certification
  • marketing authorisations
  • pharmacovigilance qualifications
  • manufacturing and distribution licenses
  • inspections of good manufacturing practice (GMP) attached to it
  • marketing authorisation applications (through either the centralised or decentralised mechanisms)

The UK will recognise any of the above that originate from the EU also.

The change to the guidance reiterates the fact that formerly UK-based outfits in the medicines area will continue to make widespread changes to its operations to keep up with the post-Brexit legal landscape.

Relevant updates will be published here as they become available

Posted by Sarah-Jane Dobson

International products lawyer, Cooley LLP