Today, the U.K.’s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. The agency also opened consultation on its planned retirement of the European Commission Decision Reliance Procedure.
Background: MHRA’s reliance on European Commission decisions and the intend to expand recognition to additional regulators
The official exit from of the U.K. from the E.U. on February 1, 2020 started a year-long transition period; The E.U. pharmaceutical law ceased to apply to the U.K. (excluding Northern Ireland) as of January 1, 2021.
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