Landing in UK: Following Brexit and in order to avoid stock-outs in the UK

Following Brexit and in order to avoid stock-outs in the UK, the MHRA has made exceptional procedures.

1. – European Commission (EC) Decision Reliance Procedure:
   • For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.
   • More info https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure

1. – Decentralised and mutual recognition reliance procedure for marketing authorisations:
   • The MHRA has the power to have regard to Marketing Authorisations (MAs) approved in EU Member States (or Iceland, Liechtenstein, Norway) through decentralised and mutual recognition procedures with a view to granting the MA in the UK or Great Britain (England, Scotland and Wales).
   • The intention is that acceptable MAs should be granted within 67 days of MAA validation.
   • More info  https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations

At Azierta, we have a team of multidisciplinary experts ready to help you in any of these cases, speeding up the process as much as possible.