UK will not be acting as a leading authority for medicines during Brexit transition

UK will not be acting as a leading authority for medicines during Brexit transition.

Medicines and Healthcare products Regulatory Agency (MHRA) confirmed in a statement in February 2020 that during the 1-year Brexit transition, the United Kingdom will not be acting as a leading authority for medicines.

The role of a leading authority conducts assessments on behalf of specific EU agencies. Both the UK and EU are still in the midst of a discussion on the activities this article (leading authority) will cover with respect to medicines. However, it is confirmed that medical devices will not be covered.

MHRA’s role in the European Medicines Agency (EMA) and EU committees will see drastic changes with immediate effect from the issuance of the statement. The UK will no longer have voting rights and will have to continue to respect EMA and EU committees’ decisions on drug and device approvals.

The UK is permitted to continue in the participation of decentralized and mutual recognition licensing procedures. But, they are prohibited from acting as a Reference Member State in matters relating to the approval of marketing authorizations. They are also not allowed to act as a rapporteur or co-rapporteur.

Biopharma companies will still be able to continue with batch release testings and Qualified Person certifications in the UK. Marketing authorization holders and qualified persons for pharmacovigilance would still able to be based in the UK and gain access to EU markets.