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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.
Latest over-arching guidance from the MHRA
Collection of guidance and publications about a possible no-deal Brexit
Guidance on how to register to make submissions to the MHRA in the event of no deal
Webinars on how to submit regulatory information in the event of no-deal
Regulation of medicines and clinical trials
Guidance on marketing authorisations, variations and licensing guidance if there is a no-deal Brexit
Guidance on importing and exporting medicines if there is a no deal Brexit
Guidance on the regulation of medicines for children if there’s a no-deal Brexit
Guidance on regulatory submissions and vigilance activities if there is a no-deal Brexit
Data
Guidance and resources to help SMEs prepare for data protection compliance after a no-deal Brexit
Guidance from the IPO on IP and Brexit
Changes to SPC and patent law if the UK leaves the EU without a deal
The Government has consulted on how the SPC manufacturing waiver will operate in a no-deal scenario but no decision has yet been made
Information from the European Medicines Agency
Information on EMA preparedness and business continuity planning