Selection of Reference Medicinal Products (RMPs) for the UK
Starting from 1 January 2025, there will be legislative changes affecting the selection of Reference Medicinal Products (RMPs) used to support abridged applications for UK-wide marketing authorisations.
RMPs are crucial for new generic medicines and other abridged marketing authorisation applications. This document outlines the definition of an RMP and how RMP-related data can be leveraged to support UK marketing applications.
Changes Effective from 1 January 2025
UK-Wide Applications: With the implementation of the Windsor Framework on 1 January 2025, the definition of RMPs for UK-wide applications are set out in regulation 48(2) of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024.
RMPs must be or have been authorised for not less than 8 years and include:
- Products authorised by the MHRA for the entire UK (either via one or multiple UK authorisations).
- Products authorised through conversion from EU marketing authorisations. EU marketing authorisations not converted to GB MAs will not be acceptable as RMPs.
Data and market exclusivity (DME) period entitlements for reference medicinal products approved before 1 January 2021 will remain valid in the UK, including any remaining DME periods for converted EU authorisations.
Applicants should be aware of extensions to market protection periods, for example, if a new indication was granted to the reference medicinal product within the first 8 years of its authorisation.
Northern Ireland: As of 1 January 2025, RMPs used in marketing authorisation applications submitted into Northern Ireland only (excluding Great Britain) must continue to comply with the relevant EU legislation.
Validity of Applications and Authorisations Based on a ‘European Reference Medicinal Product’: UK authorisations and pending applications based on a ‘European Reference Medicinal Product’ (ERP) as described in Article 10.1 of Directive 2001/83 (as amended) will remain valid in the following scenarios:
- Any UK-wide authorisation granted before 1 January 2025.
- Any pending UK-wide marketing authorisation (MA) application submitted before 1 January 2025. For applications seeking UK-wide authorisations (including Great Britain and Northern Ireland), applicants will need to comply with Northern Ireland’s requirements until the implementation of the Windsor Framework on 1 January 2025, during which time an EU RMP will be necessary.
- From 1 January 2025,
The definition of RMPs for applications to Great Britain only is set out in regulation 48(2) of the Human Medicines Regulations 2012 as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. These include:
RMPs must be or have been authorised for not less than 8 years. Acceptable RMPs include products authorised for the UK (including those authorised by conversion from EU marketing authorisations)
Products that had an EU marketing authorisation on 1 January 2021 but which did not convert into Great Britain marketing authorisations as the holder opted out of that process.
Data and market exclusivity (DME) period entitlements for reference medicinal products approved before 1 January 2021 continue to apply in the UK including remaining periods of DME for converted EU authorisations, previously applicable only to Great Britain, will apply across the UK. After this date, applicants seeking UK-wide marketing authorisations will be unable to use an ERP and must use an RMP authorised in the UK for more than 8 years, depending on the applicable data exclusivity period.
- Any granted authorisation or pending application for Northern Ireland-only authorisations, irrespective of the submission date, will continue to follow EU requirements.
Non-UK Comparator Products: Non-UK comparator products used in bioequivalence or therapeutic equivalence studies are permitted for:
- GB MA applications submitted on or before 31 December 2024.
- UK-wide MA applications submitted on or after 1 January 2025.
Reference:
https://www.gov.uk/guidance/reference-medicinal-products-rmps
