Supplementary Guidance on UK-Wide Licensing for Human Medicines

1. Publication Details

Published 31 January 2025. This publication is licensed under the Open Government Licence v3.0. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

2. Overview

The guidance on UK-wide licensing for human medicines provides information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. This supplementary guidance addresses common queries about UK-wide licensing. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

3. Glossary of Terms

For clarity and consistency, this guidance uses the following definitions:

• MA: marketing authorisation
• IRP: international recognition procedure
• UK-wide MA: a product licensed by the MHRA across the whole of the UK (may include MAs with PL or PLGB prefix)
• NI MA (PLNI): a product licensed by the MHRA covering Northern Ireland only with PLNI prefix
• GB MA: a product licensed by the MHRA covering Great Britain only (authorisations before 1 January 2025 with PLGB prefix are now valid UK-wide; new PLGB numbers not issued after 1 January 2025)
• Union authorisation: an MA issued by the European Commission for a product approved through EMA centralised procedure
• Centrally Authorised Product (CAP): a medicinal product authorised through a Union Authorisation valid across the EU https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4. Transitional Arrangements

From 1 January 2025, the MHRA regulates all medicines across the UK. Applications authorised via EU centralised procedure are not valid in the UK (NI) from this date; national MA applications required for UK-wide authorisation. GB MA applications not possible from 1 January 2025. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.1 Great Britain MAs (PLGBs) Granted up to 31 December 2024

GB MAs granted on or before 31 December 2024 automatically converted to UK-wide on 1 January 2025, unless cancelled by 31 December 2024. No individual notifications issued. Product information approved for Northern Ireland through EU procedure superseded by UK-wide MA from 1 January 2025. MA number with PLGB prefix unchanged. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.2 Pending Applications via EU Centralised Procedures on or Before 31 December 2024

Outcomes of initial and post-authorisation applications authorised by EC on or after 1 January 2025 do not take effect in Northern Ireland. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.3 Marketing Authorisations Granted by EC on or Before 31 December 2024

Authorisations ceased validity in Northern Ireland from 1 January 2025. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.4 Pending GB MA Applications Submitted on or Before 31 December 2024

Processed per national requirements as of 31 December 2024; outcomes apply UK-wide. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.5 UK-Wide MA Applications Submitted up to 31 December 2024

Processed per requirements as of 31 December 2024; no updates needed due to Windsor Framework; outcomes apply UK-wide with PL prefix retained. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

4.6 UK-Wide MAs Granted up to 31 December 2024

Continue with UK-wide validity from 1 January 2025; PL prefix retained. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

5. Category 1 and Category 2

From 1 January 2025, medicines previously in EU centralised procedure authorised under UK-wide MAs. Products not in scope authorised UK-wide under UK and EU law. New applications and existing products assigned Category 1 or 2 for rule application. For criteria, see guidance on UK-wide licensing for human medicines. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance Certain products not categorised: NI-only MAs, traditional herbal registrations, homeopathic registrations, unlicensed medicines, parallel imports, investigational products. View MHRA lists of Category 1 and 2 products. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance For queries, email RIS.NA@mhra.gov.uk with header ‘LICENCE CATEGORY’. New products' categorisation in bi-weekly lists of new marketing authorisations. Applicants assign category via Human Medicines portal; MHRA assesses and corrects if needed. Incorrect categorisation does not invalidate application; final category in grant letter. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

6. Product Information Divergence from EU

EU MAs not valid in NI from 1 January 2025. If same product authorised in GB on 31 December 2024, MA converts to UK-wide; GB product information applies UK-wide from 1 January 2025. Overlap in supply chain: EU packs QP certified before 1 January 2025 supplied in NI until expiry. MHRA does not expect alignment before 1 January 2025. Differences managed pragmatically. Proactive communication to NI healthcare professionals for significant clinical practice changes affecting safety. Internal safety updates via variation process with 3-6 month timelines. See guidance on pharmacovigilance post-Windsor Framework. Contact safetyprojects@mhra.gov.uk for case-by-case advice. Refer to guidance on advertising and promotion post-Windsor Framework. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

7. Reference Medicinal Products (RMPs)

From 1 January 2025, only RMPs authorised at least 8 years in UK (or GB before) valid for citation in UK-wide generic, hybrid, biosimilar applications. European reference products no longer permitted. Applies to national applications including IRP, Project Orbis, Access Consortium. Since EU exit, MHRA expects national MA holders update SmPCs/PILs per UK authorised innovator. Where not possible, safety updates to generics of EU reference via IRP variations. NI-only applications (PLNIs) comply with EU RMP requirements. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

8. Demonstrating Non-UK Comparator Product Representative of UK RMP

Comparator products (CPs) in bioequivalence (BE), pharmacokinetic (PK), therapeutic equivalence (TE) studies should represent UK RMP. If not UK-sourced, provide evidence. Physico-chemical testing of 3 batches usually required. For recent shared regulatory history, justification without testing possible. Acceptable for CPs as centrally authorised valid in NI until 31 December 2024 or MRDC with NI as CMS. Not for complex/high variability products. See detailed guidance on comparator products. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

9. Applications for Established Medicines Without UK RMP

Submit under different legal basis, e.g., well-established use (regulation 54) or full mixed dossier (regulation 50). https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance

10. Well Established Use

National MA applications accepted under well-established use (Regulation 54). Replace pre-clinical/clinical trials with scientific literature if active substances in claimed indication have 10-year well-established use in UK or EU with recognised efficacy/safety. Windsor Framework does not alter; post-1 January 2025, accept based on EU 10-year use. Option where no UK RMP established. https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines-supplementary-guidance/uk-wide-licensing-for-human-medicines-supplementary-guidance