MHRA has been providing updated guidance to assist industry in the run up the end of the Brexit transition period, as well as organising focussed webinars to support specific regulatory topics.
Some key take-away points about the medicinal product supply chain are as follows:
- Under the transition protocol, Northern Ireland continues to participate in — and be bound by — EU regulations.
- Current wholesale dealers in Great Britain must appoint a ‘Responsible Person (import)’ (RPi) to perform checks to allow importation of QP released medicinal products from an EEA country on the approved for import list.
- From 1 January 2021 there will be a six-month period in which to notify MHRA in writing of a current wholesale dealer’s intention to continue to perform importation into GB from the EAA, and implement the necessary checking process.
- There will then be a further eighteen-month period during which MHRA must be notified of the named individual acting as RPi, via the new MHRA portal.
- The individual named as RPi must meet defined criteria for qualifications, experience and affiliation to an appropriate professional body.
- There will be no automatic “grandfathering” of existing Responsible Persons.
- New GMP/GDP certificates for supplier qualification will be provided via a ‘MHRAGMDP’ database from 01 January 2021. However, there will be no back-loading earlier certificates so it will be necessary to continue to use EudraGMDP in parallel.
WBR maintain its own GDP license and can support your company regarding medicinal product supply chain in preparation for the end of the transition period.