Note: promotional compliance operates under industry self-regulation. Product information and labelling are assessed by the MHRA as part of the marketing authorisation process. These are separate frameworks with different approval processes, and we cover both.
UK Regulatory Landscape
The UK has its own distinct framework for product information, labelling, and promotional compliance. While much of it derives from the same EU legislation that applied before Brexit, the practical requirements have diverged in ways that matter for day-to-day compliance.
Advertising Legislation
Pharmaceutical advertising in the UK is governed by Part 14 of the Human Medicines Regulations 2012 (SI 2012/1916). The MHRA supervises advertising compliance on behalf of the licensing authority, supported by the MHRA Blue Guide (Advertising and Promotion of Medicines in the UK, Third Revision). These regulations define what constitutes advertising, set requirements for promotional content directed at healthcare professionals and the public, and establish enforcement mechanisms.
Industry Self-Regulation
Alongside the statutory framework, the UK pharmaceutical industry operates under the ABPI Code of Practice for the Pharmaceutical Industry, administered by the Prescription Medicines Code of Practice Authority (PMCPA). The 2024 ABPI Code came into full force on 1 January 2025, replacing the 2021 edition. Key changes in the 2024 Code include a rewritten Clause 12 on prescribing information (developed in consultation with the MHRA, now permitting QR codes as an efficient way to provide prescribing information), elements moving from guidance to mandatory requirement (including gateway links on Disclosure UK and written terms for HCP support), and a new abridged complaints procedure allowing the PMCPA to triage less serious complaints more efficiently while focusing resources on serious breaches.
The ABPI Code covers prescription medicines. Over-the-counter medicines are governed by separate codes: the PAGB Consumer Code (advertising to the public) and the PAGB Professional Code (advertising to healthcare professionals).
Product Information Templates
The MHRA maintains its own product information templates for UK-authorised medicinal products, which are separate from the EMA QRD templates used for EU-authorised products. While structurally similar, UK templates have diverged on specific requirements: local representative listings, safety feature statements, certain standard wording, and the use of SmPC fragments for variation submissions. Companies holding authorisations in both the UK and EU must maintain separate product information documents and track divergence between the two.
Labelling and Packaging
UK labelling requirements follow the Human Medicines Regulations and reflect post-Brexit changes including the "UK only" label requirement introduced under the Windsor Framework.
What We Handle Locally
Our UK team delivers the following within the UK regulatory and code framework. For the underlying methodology, see Product Information, Labelling & Promotional Compliance.
Certify promotional and non-promotional materials under the 2024 ABPI Code of Practice.
Our copy approval team, led by Karen Bradshaw, reviews detail aids, brochures, congress materials, digital content, email campaigns, slide decks, and video against the SmPC, HMR 2012, and the ABPI Code. We assess claims for accuracy, fair balance, and code compliance, verify prescribing information meets the rewritten Clause 12 requirements, and provide documented certification with audit trail.
Review disease awareness materials, patient-facing content, press releases, and internal training materials for compliance with UK advertising boundaries.
Ensure correct categorisation as non-promotional under MHRA and PMCPA expectations.
Review and prepare UK-format product information: SmPC, patient information leaflet, and labelling text using MHRA templates.
Manage the divergence tracking between UK and EU product information where both authorisations are held.
Verify UK packaging artwork compliance: MHRA template adherence, UK-specific national requirements content, UK braille requirements, , and UK legal status statements.
Conduct end-to-end artwork review from mock-up through print-ready files.
Conduct or review UK readability testing (user consultation) for patient information leaflets, ensuring compliance with UK requirements for demonstrating patient comprehension.
Manage UK labelling implementation following variations, safety updates, or MHRA-required changes.
Prepare annotated and clean versions for MHRA submission. Track UK implementation timelines separately from EU timelines where both apply.
Assess OTC promotional materials under PAGB Consumer Code and PAGB Professional Code requirements.
Our team has particular experience in Rx-to-OTC switch material preparation, where launch materials must comply with OTC advertising rules from day one while transitioning from a prescription-only promotional framework.
Support during PMCPA complaints or MHRA advertising enquiries.
Prepare evidence packages, draft responses, assess root causes, and develop corrective and preventive actions. Under the 2024 PMCPA Constitution and Procedure, companies now have 15 working days to respond to a complaint (extended from 10), and the abridged procedure may apply for less serious breaches.
Operate promotional governance systems for UK operations: maintain UK-specific SOPs, certification workflows, training programmes, and compliance monitoring aligned with ABPI Code requirements.
The 2024 Code made several previously recommended practices mandatory, including written terms for HCP support and gateway links on Disclosure UK.
Our UK Team
Product information, labelling, and promotional compliance in the UK is delivered by our regenold UK team. The team includes copy approval specialists who certify promotional and non-promotional materials under the ABPI Code, alongside regulatory managers and officers with experience across SmPC preparation, artwork review, readability assessment, labelling lifecycle management, UK marketing authorisation maintenance, eCTD publishing, and MHRA interactions.
For the full team, see Our Teams.
UK-Specific Considerations by Material Type
UK requirements vary by material type. The table below summarises the key considerations.
Promotional materials (prescription medicines)
Must comply with HMR 2012 Part 14 and the 2024 ABPI Code. Prescribing information can now be provided via QR codes under the rewritten Clause 12. All claims must be consistent with the UK-approved SmPC (not the EU SmPC, which may differ). Certification must be by appropriately qualified individuals. Materials must include the mandatory minimum information specified in the ABPI Code.
Promotional materials (OTC medicines)
Governed by PAGB Consumer Code (public-facing) and PAGB Professional Code (HCP-facing). Different rules apply regarding what can be claimed, how safety information is presented, and what mandatory statements are required. For products undergoing Rx-to-OTC reclassification, promotional frameworks change at the point of reclassification.
Product information (SmPC, PIL, labelling)
Must use MHRA product information templates, which have diverged from EU QRD templates. UK-authorised products must reflect UK MAH details, UK legal status, and UK-specific standard wording. For products authorised in both UK and EU, dual maintenance of product information is required.
Packaging and artwork
UK braille requirements (product name and strength on outer packaging). UK-specific national requirements content. UK MAH details. UK legal status marking.
Disease awareness and non-promotional materials
Subject to MHRA and PMCPA scrutiny. Must not cross the boundary into promotion of a specific named product. The MHRA Blue Guide provides guidance on the distinction between advertising and information. The 2024 ABPI Code maintains requirements for how disease awareness activities should be conducted.
Digital content
UK-specific requirements for HCP verification on restricted-access platforms. The PMCPA published its first guidance to pharmaceutical companies on social media in 2024, broadly aligning with EFPIA/IFPMA Joint Digital Guidelines but with UK-specific enforcement context. Email marketing must comply with UK data protection and electronic communications regulations (PECR).
Key UK Regulations and Codes
Need Promotional Compliance or Product Information Support in the UK?
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Speak with an ExpertFrequently Asked Questions (FAQ)
How does the UK advertising framework differ from the EU post-Brexit?
The core legislation (HMR 2012 Part 14) derives from the same EU Directive 2001/83/EC provisions, but the UK is no longer bound by EU legislative updates. The EU pharmaceutical legislation revision currently progressing through Council and Parliament will not apply in the UK. The UK operates its own self-regulatory system through the ABPI Code and PMCPA, which aligns with but is not identical to the EFPIA Code framework. Practical differences include: the MHRA, not EMA, oversees advertising compliance; UK product information uses MHRA templates rather than QRD; and the PMCPA operates its own complaints procedure with UK-specific timelines and enforcement powers.
What changed in the 2024 ABPI Code that affects promotional compliance?
Three key areas changed. First, Clause 12 on prescribing information was completely rewritten in consultation with the MHRA, now permitting QR codes as an alternative to printed prescribing information. Second, several requirements moved from guidance to mandatory, including Disclosure UK gateway links and written terms for HCP support. Third, the PMCPA introduced a new abridged complaints procedure for less serious breaches and extended the response period for full complaints from 10 to 15 working days. The 2024 Code came into full force on 1 January 2025.
Do we need separate UK product information if we already have EU-approved texts?
Yes. UK-authorised products must use MHRA product information templates, which have diverged from EU QRD templates on several points. The UK SmPC, PIL, and labelling must reflect the UK MAH, UK-specific legal status, and any UK-specific standard wording. Companies holding authorisations in both jurisdictions must maintain and update both sets of product information independently, and track where divergence has occurred between the UK and EU approved texts.
How does the PMCPA complaints process work under the 2024 Constitution?
Complaints can be submitted to the PMCPA by anyone. Under the 2024 Constitution, the PMCPA can apply an abridged procedure for complaints that meet certain criteria (breach falls within the PMCPA’s approved list, central facts are not disputed, and a clear breach is likely). Under the abridged procedure, respondents have 15 days to accept the breach and provide undertakings. For full complaints, companies also now have 15 working days to respond (extended from 10). The PMCPA has also introduced case management directions, giving it greater administrative powers during investigations. Serious breaches are investigated in full by the Code of Practice Panel and, where required, the Appeal Board.
Do you handle OTC promotional compliance as well as prescription medicines?
Yes. We review OTC materials under the PAGB Consumer Code (public-facing advertising) and the PAGB Professional Code (HCP-facing advertising). This is particularly relevant for products undergoing Rx-to-OTC reclassification, where the entire promotional framework changes at the point of switch. Launch materials must comply with OTC advertising rules from day one, and any pre-switch promotional content must be withdrawn or revised. Our team has direct experience managing this transition.
What support do you provide during a PMCPA complaint?
We assess the complaint, gather evidence, prepare the company’s response within the 15-working-day deadline, evaluate root causes, and develop corrective and preventive actions. For complaints under the abridged procedure, we help determine whether to accept the breach and draft appropriate undertakings. For full investigations, we prepare detailed responses, coordinate across internal teams, and advise on engagement with the Code of Practice Panel. We also support post-case remediation, including any required corrective statements or changes to materials.
What happens to our promotional materials when a product switches?
All prescription-only promotional materials must be withdrawn at the point of reclassification. New OTC materials must comply with PAGB Consumer Code (public-facing) and PAGB Professional Code (HCP-facing). The promotional framework changes fundamentally: what you could say under the ABPI Code is not the same as what you can say under PAGB. We manage this transition, including preparing OTC-compliant launch materials and withdrawing Rx materials.