MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

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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