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Regulatory Focus™ > News Articles > 2020 > 2 > UK Steps Back From ‘Leading Authority’ for Drugs in Brexit Transition

UK Steps Back From ‘Leading Authority’ for Drugs in Brexit Transition

Posted 18 February 2020 | By Zachary Brennan 

UK Steps Back From ‘Leading Authority’ for Drugs in Brexit Transition

The UK will not act as a “leading authority” for medicines during the one-year Brexit transition, although UK and EU negotiators are still trying to fine-tune what that means in practice, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in an updated guidance on Tuesday.

The meaning of “leading authority” depends on interpreting Article 123 of the draft withdrawal agreement, which says: “During the transition period, the United Kingdom shall not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States acting jointly referred to in the acts/provisions listed in Annex y+6.”

According to MHRA, a “leading authority” conducts assessments on behalf of specific EU agencies, but the UK and EU “are still discussing the scope of activity that this article will cover with respect to medicines. It does not cover medical devices.”

Regardless, MHRA’s role will change immediately. For instance, the UK will no longer have voting rights in the European Medicines Agency (EMA) and EU committees, but the UK will continue to respect their drug and device approval decisions.

Under the withdrawal agreement, the UK can continue to participate in the decentralized and mutual recognition licensing procedures, MHRA adds, but the UK is excluded from acting as a Reference Member State (RMS) in procedures related to the approval of marketing authorizations. In addition, the UK cannot act as a rapporteur or co-rapporteur.

As for biopharma companies, the MHRA says they will be able to continue UK batch release testing and Qualified Person certification in the UK, which are recognized by the EU and vice versa. Last July, the European Commission said that batch testing had to be moved from the UK to the EU by the beginning of 2020.

MHRA further notes that marketing authorization holders and qualified persons for pharmacovigilance can still be based in the UK and access EU markets.

“There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP),” the regulator adds.

The release of the updated guidance on the transition period comes as last week, the UK government also introduced a bill to update its post-Brexit regulatory framework for human and veterinary medicines, clinical trials and medical devices.

Updated MHRA Guidance

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