The Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK's medicines regulator from 1 January 2021. Your MAs will remain in force until a decision has been made on your renewal applications. If a final decision has been made on your renewal but it hasn't been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.
The MHRA will continue to accept reduced submission requirements for renewals of MAs for products authorised under Article 10.1. From 1 January 2021, you should continue to submit your renewal applications for conditional MAs 6 months before they expire. For Great Britain MAs, the application should be submitted to the MHRA, who will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012. The same applies to converted EU MAs that were granted as conditional MAs. Where the MA has remained in line with the EU or Northern Ireland MA , MHRA - will accept the same renewal application as submitted.