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.
During the transition period, medicines and devices regulation will stay aligned with the EU from 1 February 2020 until 31 December 2020.
The Medicines and Healthcare Products Regulatory Agency has published post-transition period guidance for industry on medicinal products and active substances regulation following the end of the transition period on 1 January 2021. It includes information on licensing, clinical trials and import/export. It does not cover products entering Northern Ireland from Great Britain. MHRA is holding a series of webinars on the guidance from 19 October to 29 October.
Previous ‘no deal’ guidance
If new arrangements on medicines and devices regulations are not agreed with the EU by 31 December 2020, trade between the UK and EU would revert to WTO rules. This could be equivalent to the ‘no deal’ scenario for which the government provided guidance ahead of 31 October 2019 - see the links below.