Is the clock now ticking for European Pharmaceutical manufacturers to select their Lot and Batch Release testing laboratory in the UK to transfer their required methods before the deadline of the 1st January 2023?
In the Trade and Cooperation Agreement it states:
“A Party shall recognise inspections carried out by the other Party and shall accept official GMP documents issued by the other Party in accordance with the laws, regulations and technical guidelines listed in Appendix B.”1
This means we have mutual recognition of audits but not a mutual recognition of batch release testing into the EU, unless a Mutual Recognition Agreement is put in place. This does not appear likely based on the EMA’s previous statement.
However, the UK will recognise batches of pharmaceuticals release tested in the EU until 31st December 2022 for import into the UK as stated by the UKs Department of Trade and Industry.2
As of the 1st of January 2023 everything is open to change.
So is time now running out to select a UK GMP QC laboratory to transfer your batch release testing methods into?
Talk to our team today to discover the benefits of partnering with Tepnel for batch release testing.
What does Brexit mean for Tepnel?
Though the rules for Lot & Batch Release testing have changed due to Brexit, the following Tepnel services remain unchanged and we can continue to offer our remaining wide range of services to both the UK and the EU:
• ICH Stability Testing & Storage
• Pharmacopeial & Raw Materials Testing
• ICH Method Development & Validation
Contact us today to find out how Tepnel can support you.
References:
1. TRADE AND COOPERATION AGREEMENT (Brexit deal) ANNEX TBT-2: MEDICINAL PRODUCTS on pp 492 – 503, https://assets.publishing.service.gov.uk/government/upload
s/system/uploads/attachment_data/file/948119/EU-UK_Trade_and_Cooperation_Agreement_24.12.2020.pdf
2. https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines
You may also be interested in:
Lot and Batch Release Testing
Raw Material Testing
ICH Method Development and Validation
ICH Stability Testing and Storage
