As previously discussed in our article on Brexit-related challenges for the life sciences sector dated 12 February 2021, batch testing was omitted from the Trade and Cooperation Agreement (TCA) signed by the UK and EU on 30 December 2020. Whilst the EU is yet to grant recognition of batch testing, the UK granted a 2-year period for unilateral recognition of batch testing and Qualified Person certification conducted in the EEA, which was scheduled to end on 1 January 2023.

However, according to updated Medicines and Healthcare Products Regulatory Agency (MHRA) guidance published on 16 March 2021, the UK’s continued recognition of EU/EEA batch testing will be reviewed no later than 30 December 2022, with any changes being subject to a 2-year notice period. This means the UK’s acceptance of EU/EEA batch testing will no longer end on 1 January 2023, and should a comprehensive review of future batch testing requirements recommend a reinstatement of batch testing, industry would have 2 years to implement this change.

According to the Association of the British Pharmaceutical Industry (ABPI), the review is not expected to start in the coming months as the Government is currently prioritising supply to the UK throughout the pandemic. The ABPI also continues to call on the UK and EU to sign a Mutual Recognition Agreement (MRA) for batch testing. However, at the very least, this announcement is no doubt welcomed by many industry members, for whom the immediate setting up of duplicative batch operations amidst a pandemic would have proven incredibly difficult.

For further information please contact Marilyn Acquah or Julia Gillert of our London office.

Author

Julia is a key member of the Firm's Healthcare Practice Group, at the London, EMEA and global level. She advises both domestic and international companies in the medtech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters including industry code compliance, interactions with healthcare professionals and patients, genetic testing, clinical research, virtual health, CQC registrations, market access, biological products, patient support programs, digital health applications, borderline products, pre-licence communications, CE marking, marketing authorisations. Julia sits on the Legal Committees of the Association of British HealthTech Industries and the Association of the British Pharmaceutical Industry, and is a spokesperson for the Firm on healthcare issues arising in connection with Brexit.

Author

Marilyn is a trainee solicitor at Baker McKenzie.

Write A Comment