UK-Wide Licensing for Human Medicines

Introduction and Policy Change

The UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA) have implemented changes to the licensing of human medicines following the Windsor Framework agreement. This guidance explains how medicines will be authorised on a UK-wide basis rather than through separate authorisations for Great Britain (GB) and Northern Ireland (NI).
Source: UK-wide licensing for human medicines

From 1 January 2025, the MHRA will regulate medicines through UK-wide marketing authorisations (MAs), meaning a single licence covers the entire UK market. Medicines authorised before this date retain their existing authorisation numbers (including PLGB prefixes) but are considered UK-wide under the new regime.
Source: UK-wide licensing for human medicines

Key Concepts and Terminology

In the context of UK-wide licensing:

• UK-wide MA refers to a licence issued by the MHRA valid throughout the United Kingdom.
• GB MA (PLGB) refers to a licence previously valid only in Great Britain (England, Scotland, Wales).
• NI MA (PLNI) refers to a licence for Northern Ireland only.
  Source: UK-wide licensing for human medicines

Implementation of the Windsor Framework

The Windsor Framework modifies the regulatory landscape so that:

• Union authorisations (EU centralised marketing authorisations) will no longer be valid in Northern Ireland. Instead, the MHRA will issue UK-wide authorisations for these products.
• Applications pending on 1 January 2025 will follow the UK-wide rules, with the licence number and prefix determined by the status at the time of application.
  Source: UK-wide licensing for human medicines

The MHRA retains the ability to issue GB-only MAs in exceptional circumstances to safeguard public health, but these are not generally available through standard application routes after 31 December 2024.
Source: UK-wide licensing for human medicines

Category 1 and Category 2 Products

Under the new UK-wide licensing:

• Category 1 products are those that previously fell within the scope of the EU centralised procedure (e.g., new active substances, orphan medicines, advanced therapy medicinal products).
• Category 2 products include medicines that were not within the EU centralised scope; both categories will be authorised on a UK-wide basis under MHRA regulation.
  Source: UK-wide licensing for human medicines

Impacts on Marketing Authorisation Numbers

From 1 January 2025:

• New UK-wide MAs will bear a PL prefix (indicating UK marketing authorisation).
• Existing licences with PLGB prefixes remain valid and are recognised UK-wide.
• Union authorisations no longer apply to NI and are replaced by MHRA UK-wide authorisations.
  Source: UK-wide licensing for human medicines

Reference Medicinal Products and Data Exclusivity

Under the UK-wide system, reference medicinal products (RMPs) cited in generic, hybrid or biosimilar applications must be authorised in the UK and have a minimum of 8 years of UK authorisation. European reference products without UK licensing will not be accepted for UK-wide applications after 1 January 2025.
Source: UK-wide licensing for human medicines

Territorial Application and Transition

Existing marketing authorisations are automatically converted to UK-wide licences on 1 January 2025, with no action required by the marketing authorisation holder (MAH) in most cases. Separate NI or GB licences are phased out except in limited circumstances under EU mutual recognition or decentralised procedures.
Source: UK-wide licensing for human medicines

Conclusion

The UK-wide licensing regime simplifies the human medicines licensing framework by unifying regulatory oversight under the MHRA, enhancing clarity for marketing authorisation holders, and ensuring a single licence covers the entire United Kingdom from 1 January 2025 onward.
Source: UK-wide licensing for human medicines