Reference medicinal products (RMPs)
Source: gov.uk (2025-03-11)

There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.

1. Overview

From 1 January 2025, there are changes to the legislation which affect reference medicinal products (RMPs) used to support abridged applications for UK-wide marketing authorisations.

RMPs are required for new generic medicines and other abridged marketing authorisation applications. This document defines what an RMP is, and how data based on an RMP can be used to support UK marketing applications.

2. Changes in requirements before and after implementation of the Windsor framework

Before 1 January 2025

2.1 Great Britain (England, Wales and Scotland)

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.

2.2 Northern Ireland

EU legislation applies in Northern Ireland.

The definition of RMPs for applications to or including Northern Ireland 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.

The RMP must be or have been authorised for not less than 8 years, acceptable RMPs include:
- UK authorised products
- products in relation to which an EU marketing authorisation has been granted
- products to which a competent authority of an EEA state has granted a marketing authorisation
2.3 UK-wide applications

Applicants seeking UK-wide marketing authorisations (Great Britain and Northern Ireland) must comply with requirements applicable in Northern Ireland and the RMP must be or have been authorised for the whole of the UK

From 1 January 2025

2.4 UK-wide applications

Following implementation of the Windsor Framework on 1 January 2025, the definition of RMPs for applications 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 whole of the UK (whether by one or more UK authorisations)
- products authorised by conversion from EU marketing authorisations
EU marketing authorisations that were not converted to GB MAs will not be acceptable RMPs.

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.

Applicants should be aware of extensions to market protection periods, for example for a new indication granted to the reference medicinal product within the first 8 years of its authorisation.

2.5 Northern Ireland

From 1 January 2025, RMPs cited in marketing authorisation applications submitted into Northern Ireland only (not including Great Britain) should continue to comply with relevant EU legislation (as explained in 2.2 above).

3. 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)2 are valid in the following circumstances:

1) Any UK-wide authorisation granted before 1 January 2025.

2) Any pending application for a UK-wide MA submitted before 1 January 2025. Applicants seeking UK-wide marketing authorisations (Great Britain and Northern Ireland) must comply with requirements applicable in Northern Ireland until implementation of the Windsor Framework on 1 January 2025 and therefore, will be required to have an EU RMP. From 1 January 2025 the provisions explained in section 2.1 above, applicable in Great Britain until 31 December 2024, will apply across the UK. Applicants seeking UK-wide marketing authorisations (Great Britain and Northern Ireland) on or after 1 January 2025 will be unable to use a European Reference Medicinal Product (ERP) and will need to use a RMP which has been authorised in the UK for more than 8 years, depending on the applicable data exclusivity period applied.

3) Any granted authorisation or pending application for an authorisation in Northern Ireland only regardless of submission date because EU requirements apply.

2. Article 10 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32001L0083

4. Non-UK comparator products

Non-UK comparator products used in bioequivalence or therapeutic equivalence studies are permitted for:
- GB MA applications submitted until and including 31 December 2024
- UK-wide MA applications submitted on or after 1 January 2025
Where a comparator product used in bioequivalence or therapeutic equivalence studies is not sourced from the UK market, the applicant should provide evidence that it is representative of the UK reference medicinal product. Further guidance on the evidence required has been published here: Comparator products in bioequivalence/therapeutic equivalence studies - GOV.UK (www.gov.uk) (https://www.gov.uk/guidance/comparator-products-in-bioequivalencetherapeutic-equivalence-studies)

5. Contact

For further information, email our Customer Services Centre at xxx@xxx.xx (mailto:xxx@xxx.xx) or call xx-xxxx-xxxx.