From 1 January 2021 reference medicinal products will have to fall within the definition in regulation 48 of the Human Medicines Regulations 2012. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period. Data and market exclusivity period entitlements for reference medicinal products approved before 1 January 2021 will continue to apply in the UK.
This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. For Northern Ireland, the definition of a RMP in regulation 48 of the Human Medicines Regulations 2012 should comply with relevant EU legislation. Applicants seeking UK-wide marketing authorisations will be required to comply with requirements applicable in Northern Ireland.