Guidance

Advertising and promotion following agreement of the Windsor Framework

Updated 11 March 2025

© Crown copyright 2025

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This publication is available at https://www.gov.uk/government/publications/advertising-and-promotion-following-agreement-of-the-windsor-framework/advertising-and-promotion-following-agreement-of-the-windsor-framework

1. Overview

New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework. This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.    

This guidance should be used in conjunction with the MHRA’s guidance on the Windsor Framework including UK-wide licensing for human medicines. This guidance should also be used to supplement the operational guidance in the MHRA’s existing Blue Guide on the Advertising and Promotion of Medicines in the UK.

2. Glossary of terms

For the purposes of clarity and consistency, this guidance uses the following definitions of key terms:

  • UK-wide MA: a product licensed by the MHRA, across the whole of the UK, (this may include MAs with a PL or PLGB prefix).
  • NI MA (PLNI): a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application with PLNI as the MA number prefix.
  • GB MA (PLGB): a product licensed by the MHRA that covers Great Britain (GB) only as the territorial application with PLGB as the MA number prefix.

3. Legislative basis

From 1 January 2025, all medicines in the UK will be licensed by the MHRA and authorised under the Human Medicines Regulation 2012 (as amended) (HMRs)

Products that fall within the mandatory or optional scope of the EU’s Centralised Procedure that, following the UK’s exit from the EU, were eligible for authorisation by the EC in NI (as a Centrally Authorised Product (CAP)) will now be authorised UK-wide by the MHRA.

Marketing authorisation holders (MAHs) will still be able to have an NI MA as outlined in the UK-wide licensing guidance. Additionally, the MHRA will retain the right to issue GB MAs after 1 January 2025, in exceptional circumstances to safeguard the interests of patients’ health within the UK.

The UK legislation regulating the advertising of medicines applies to all forms and means of advertising licensed medicinal products. As well as products with a UK-wide licence, it also covers products licensed by the MHRA for sale only in Great Britain (GB) or only in Northern Ireland (NI) where those continue to exist.

The relevant UK legislation on advertising is Part 14 of the Human Medicines Regulations 2012 (“the Regulations” – SI 2012/1916 as amended). Further information on the legislative framework outlining the requirements for the advertising and promotion of medicinal products in the UK is given in the MHRA Blue Guide.

 4.1 UK-wide advertising

Following changes made by the Windsor Framework, the vast majority of Marketing Authorisations (MAs) will be UK-wide and as such these medicinal products can be advertised UK-wide.

4.2 UK territory-specific advertising

In the exceptional circumstances where a medicinal product is only licensed in part of the UK (for example, GB or NI), the product may only be advertised in the territory where it is licensed. MAHs and advertisers must take reasonable precautions to ensure that advertisements do not appear in a territory where the product is not licensed.

In these cases, applicable territory-specific information in the advertisement continues to be required for these products as outlined in the Blue Guide (chapters 5 and 6).

4.3 Licence numbers

The HMRs require that advertisements to Persons Qualified to Prescribe or Supply (PQPS) list a series of particulars for the medicinal product(s) being advertised. These particulars include the product licence number, and the name and address of the MAH.

From 1 January 2025, the EU licence number that was assigned to licences in respect of the territory of NI no longer applies: this number should be phased out from UK advertisements over time. We do not expect this to take place by or on 1 January 2025, but request that this change is done at the earliest available opportunity to avoid any potential confusion. Statutory particulars for UK advertisements to PQPS shall need to refer to the appropriate licence numbers with the prefixes outlined in section 2 above.

4.4 Other updates

When making any updates to prescribing information, companies and advertisers are advised to take the opportunity to review the information to remove, amend, or clarify any references to territories as may be appropriate to avoid any potential confusion. For example, the statement that a product has a GB MA may need to be removed where this is changing to a UK-wide MA from 1 January 2025; headings that may have signposted to specific geographical regions at whom the information was targeted may also need to be reviewed as required.

4.5 Provision of professional samples to persons qualified to prescribe or supply medicinal products

The HMRs outline a series of conditions relating to the supply of a free sample of a licensed medicinal product to PQPS for the purpose of acquiring experience in dealing with the medicinal product.

One such condition that continues to apply, inter alia, is that the sample shall be no larger than the smallest presentation available for sale in the UK or part of the UK (GB or NI) where the supply is made.

5. Advertisements across Europe

Companies and advertisers that wish to produce promotional materials Europe-wide do so on their own responsibility and must ensure that any such advertising campaign complies fully with Part 14 (Advertising) of the HMRs—i.e., overall the material must not mislead a UK audience and material must comply with the UK Summary of Product Characteristics (SPC). Further information on the overall quality standards required of all UK advertising is outlined in chapter 4 of the Blue Guide.

In line with overall obligations to keep all promotional information up to date, material that no longer complies with UK requirements should be withdrawn from use in the UK.

5.1. Considerations for Europe-wide advertising

For the avoidance of doubt, the use of the same advertisement across Europe would not be possible where the product(’s’) indication(s) differ in the UK from that of other European territory(ies). Such advertisements would not comply with the UK SPC.

Divergence between other information in UK and European licences may not necessarily preclude the issuing of a joint advertisement across the Europe. However, care is required at all times to ensure that the safety of the UK public is not in any way compromised. This responsibility is that of the advertiser.

6. Role of the MHRA

The MHRA is obliged to consider complaints made to it about the advertisement of medicines, looking at the facts of a particular case on their own merits. Further information about the MHRA’s ongoing monitoring and supervisory role in relation to advertising and promotion is outlined in the Blue Guide.

7. Further information

  • MHRA Blue Guide on the Advertising and Promotion of Medicines
  • Email advertising@mhra.gov.uk if after consulting the Blue Guide you are unable to find an answer to your query. Note that we are unable to offer specific copy advice
  • For anything else, please email our Customer Services Centre at info@mhra.gov.uk or telephone 020 3080 6000
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