Post-transition guidance from the MHRA: Licensing

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements regarding pharmaceutical and biological product licensing.

The 12 post-transition guidances explain how various aspects of pharmaceutical and biological product licensing will work beginning 1 January 2021.

The guidances include:

On 1 January 2021, all CAP marketing authorisations (MA) will automatically be converted into UK marketing authorisations. Existing CAPs will remain valid in Northern Ireland (NI). If marketing authorisation holders (MAH) would like to remove an MA from the UK, they must let the MHRA know by 21 January 2021.

“If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with the Government on details related to individual medicines as well as on issues related to the Northern Ireland protocol and on other areas of regulation.”