Promotion of medicines in the EU
EU Directive 2001/83/EC, including the advertising and inducement framework for medicinal products.
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.
For European compliance support, our country guides cover Germany, France, Spain, Italy, the Netherlands, Portugal, Ireland and Sweden, each summarising national law and industry codes with links to the official sources.
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.
Primary references
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.
Questions, answered
Pharmaceutical compliance rules: common questions
What is the difference between pharmaceutical law and industry codes?
Laws, such as EU Directive 2001/83/EC, the UK Human Medicines Regulations 2012 and the UK Bribery Act 2010, apply to every company in scope. Industry codes of practice, such as the EFPIA Code and national codes like the ABPI Code, are self-regulatory rules set by trade associations for their members and the companies that agree to follow them.
How does the EFPIA Code relate to national codes?
The EFPIA Code sets European standards, and EFPIA’s member associations implement it through national codes. For disclosure of transfers of value, member associations must transpose the EFPIA requirements in full except where national law prevents it, and national codes can be stricter.
When did the 2024 ABPI Code of Practice take effect?
The 2024 ABPI Code took effect on 1 October 2024, with a transition period to 31 December 2024. It is administered by the PMCPA independently of the ABPI.
What is the failure to prevent fraud offence?
It is a corporate offence introduced by the UK Economic Crime and Corporate Transparency Act 2023, which has applied since 1 September 2025. It belongs in the assessment of pharmaceutical third-party controls.
Is this page legal advice?
No. It is an informational overview with links to official sources. Scope and application should be confirmed for the organisation, market, activity and counterparty concerned.