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