As the United Kingdom (UK) exited the EU, the MHRA introduced a mechanism that allowed the agency to rely on European Commission (EC) decisions when considering application for a UK marketing authorisation to authorise medicinal products. Offering a shortened assessment procedure for products that have already gone through the EU procedures, helps avoid duplication and costs for manufacturers, and makes the most efficient use of the MHRA resource. This procedure, known as the ECDRP, is due to come to an end on December 31, 2023.
The MHRA are now in a position to implement a more considered approach to their assessments. The proposal will only apply to medicines approved for the GB market, as until the implementation of the Windsor Framework, medicines for the Northern Ireland market must follow the EU acquis as per the Northern Ireland Protocol. The MHRA will continue to work with the Department to mitigate against any potential regulatory divergence in the short term until the implementation of the Windsor Framework.
The consultation document can be accessed via the link below: