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

Guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

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

DHSC guidance to sponsors of clinical trials

 

Regulation of medical devices

What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal

 

Human tissue and organs

Guidance from the HTA on the handling and transport of human tissue and organs if there is a no-deal Brexit

 

Data

Guidance and resources to help SMEs prepare for data protection compliance after a no-deal Brexit

 

Intellectual Property

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

Guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for Brexit

Information on EMA preparedness and business continuity planning

 

Information from the EU Heads of Medicines Agencies (HMA)

Brexit updates from the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh)