MHRA Updates Guidance on ‘No-Deal’ Brexit Scenario

September 13, 2019

The UK’s Medicines and Healthcare Products Regulator Agency updated its guidance for how medicines will be regulated in the event of a “no-deal” Brexit scenario.

To ensure that current centrally authorized products — medicines authorized for use across Europe — will automatically become UK Market Authorizations on exit day. Market Authorization Holders would have one year from exit day to provide the agency with baseline data for the conversions.

The guidance also outlines new assessment procedures for market authorizations, how orphan medicines will be regulated, and plans for how the agency will handle pediatric investigations and assessments.

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