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UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk

On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European Commission (EC) Decision Reliance Procedure (DRP)" which guides How to apply for marketing authorisation via this new procedure.

The update was related to the timeline extension, where On 30 September 2022 it was announced that the ECDRP will continue to be available until 31 December 2023, an extension of 12 months. Therefore the text “For a period of 2 years from 1 January 2021” was amended to “For a period of 3 years from 1 January 2023”.


Following the United Kingdom's withdrawal from the European Union at the end of 2020, the MHRA introduced the EC DRP as a transitional measure. EC DRP is used by the applicants for marketing for both generic products, new active substances, as well as variations if the centralised procedure has been followed in the EC.


ECDRP is designed to submit MAAs to the MHRA immediately following receipt of a positive CHMP opinion, but applications can be submitted at any time after an EU marketing authorization has been granted.


A delay in submission may impact the delivery of a decision within the 67-day timeframe. The MHRA aims to determine the Great Britain MA as soon as possible after EC approval.


Click this LINK to know more about How to apply for EC DRP route.


Also click this LINK to know more about the recent guidance on "Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment, and confirmatory testing" which details how to mitigate the risk of nitrosamine impurities being present on products, manufacturing processes should be reviewed by Marketing Authorization Holders.



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