The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases. The Medicines and Healthcare products Regulatory Agency (MHRA) launched in October 2018 a consultation on the regulation of medicines in the event of a ‘no deal’ exit, which included the proposed UK approach to the regulation of orphan medicines post-exit, including on incentives to encourage such medicines onto the UK market. Following this consultation, the MHRA, on 3 January 2019, published guidance on the UK proposed arrangements for the regulation of orphan medicines, in the event of a ‘no deal’ exit. This can be accessed at the following link: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal