Regulation & IP
The UK’s withdrawal from the EU will have an impact on the regulation of medicines, medical devices and clinical trials, and the protection of IP.
The following is official guidance on regulation and IP from the UK Government and relevant EU bodies.
The BIA position is that close cooperation with the EU in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the UK and the EU can continue to access safe and effective medicines.
The Government has consulted on how the SPC manufacturing waiver will operate in a no-deal scenario but no decision has yet been made