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Legal mandates

The rule behind
the process…

Legal and self-regulatory requirements translated into ownership, review routes, evidence and reporting.

Pharmaceutical compliance rests on two layers: laws that apply to every company, and industry codes of practice set by trade associations. This page summarises the main frameworks we work with, with links to the official sources. Our country guides go into local detail.

Promotion of medicines in the EU

EU Directive 2001/83/EC, including the advertising and inducement framework for medicinal products.

Promotion of medicines in the UK

Part 14 of the Human Medicines Regulations 2012 sets the legal rules on advertising medicines in the UK. The MHRA's Blue Guide explains how it applies them.

Industry codes of practice

The EFPIA Code sets European standards for relationships with healthcare professionals and patient organisations and for disclosure of payments, and national industry codes build on it. In the UK, the 2024 ABPI Code of Practice took effect on 1 October 2024 and is administered by the PMCPA, independently of the ABPI.

Anti-bribery and corruption

UK Bribery Act 2010, including section 7 failure to prevent and its extraterritorial reach, plus the FCPA and OECD Anti-Bribery Convention.

Failure to prevent fraud

The ECCTA 2023 offence has applied since 1 September 2025. It belongs in the assessment of pharmaceutical third-party controls.

National anti-gift and benefit laws

Country-specific requirements, including the French anti-gift regime under Ordonnance 2017-49, Portuguese INFARMED rules, and relevant Greek, Turkish and Polish requirements.

Transparency and disclosure

US Sunshine Act / Open Payments, France's Loi Bertrand, Danish and Portuguese registers, and the code-based EFPIA disclosure layer, published in the UK through the ABPI's Disclosure UK database.

EU AI Act and related regulation

Regulation (EU) 2024/1689, read alongside the GDPR, the EU Data Act and, where AI forms part of a medical device or diagnostic, the MDR and IVDR.

Country guides

GermanyFrancePortugal

Primary references

EU Directive 2001/83/ECHuman Medicines Regulations, Part 14MHRA Blue GuideEFPIA Code2024 ABPI Code (PMCPA)UK Bribery Act, s.7ECCTA guidanceDisclosure UKOpen PaymentsEU AI ActGDPR

This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty concerned. Sources checked September 2026.

Need these rules turned into working controls? See Local Legal Mandates and Representation or Healthcare Compliance Programme Design and Implementation.

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