In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.
The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing authorizations to how to register new packaging information for medicines after the transition date. (RELATED: MHRA posts suite of post-transition guidances, Regulatory Focus 2 September 2020).
“Our members will be reassured that Government has provided some critical information to help them continue preparations for the end of the transition,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI). “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the [National Health Service] NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland protocol and on other areas of regulation.”
As such, ABPI is calling for more technical guidance from MHRA, especially with regard to the EU’s decentralized and mutual recognition procedures and how marketing authorization variations will be handled from 1 January 2021 on…