UK government publishes 'no deal' Brexit guidance for medicines - Hogan Lovells analysis

In an Expert View piece, Elisabethann Wright (pictured above, left) and Jane Summerfield, from law firm Hogan Lovells, look at some useful points to come out of the UK government regarding the implications of a ‘hard Brexit’.

The UK government has published several guidance documents on how to prepare for Brexit in the event of a ‘no deal’ scenario. Several of the documents are relevant to pharmaceutical companies, including:

• Medicines supply contingency planning program
• How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
• Submitting regulatory information on medical products if there’s no Brexit deal
• Batch testing medicines if there's no Brexit deal
• Ensuring blood and blood products are safe if there’s no Brexit deal
• Quality and safety of organs, tissues and cells if there’s no Brexit deal

While much of the information contained in the guidance simply confirms the known or expected position, the documents do contain new information on a number of points, such as how the UK would handle issuing UK marketing authorizations (MAs) for medicines authorized at a European Union (EU) level via the centralized procedure, and timelines for moving MA holders and qualified persons responsible for pharmacovigilance (QPPVs) for UK MAs that are currently based in the EU, to the UK.