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:
- Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
- Registering new packaging information for medicines from 1 January 2021
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
- How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
- Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
- Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
- Reference Medicinal Products (RMPs) from 1 January 2021
- Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes
- Renewing Marketing Authorisations for medicines from 1 January 2021
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
- Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
- Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
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.”