Enforcement of the rules on advertising and promotion of medicinal products
Enforcement of the rules on advertising and promotion of medicinal products

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Enforcement of the rules on advertising and promotion of medicinal products
  • Introduction to the medicines advertising enforcement landscape
  • The Medicines and Healthcare products Regulatory Agency (MHRA)
  • Vetting of promotional material
  • Complaints to the MHRA
  • Corrective statements
  • Statutory enforcement action
  • Sanctions
  • Advertising Standards Authority (ASA) investigations
  • Broadcast advertising
  • More...

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

Introduction to the medicines advertising enforcement landscape

Directive 2001/83/EC on the Community code relating to medicinal products for human use (Pharmaceutical Code) establishes the rules on the advertising and promotion of medicinal products in the EU. It requires Member States to ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods must include legal provisions which allow persons or organisations regarded as having a legitimate interest in prohibiting any advertisement inconsistent with the Pharmaceutical Code to:

  1. take legal action against such advertisement, or

  2. bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings

In the UK, Part 14 of

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