Falsified Medicines
Produced in partnership with Elisabethann Wright, Marta Miglietti, Fabien Roy, Jane Summerfield, Julia Fraser and Richard Welfare of Hogan Lovells
Falsified Medicines

The following Life Sciences guidance note Produced in partnership with Elisabethann Wright, Marta Miglietti, Fabien Roy, Jane Summerfield, Julia Fraser and Richard Welfare of Hogan Lovells provides comprehensive and up to date legal information covering:

  • Falsified Medicines
  • Falsified Medicines Directive
  • What is a falsified medicine?
  • Controls on active substances
  • Obligations on various actors in the supply chain
  • EU common logo for online sales of medicines
  • Safety features
  • The Implementation Plan and EU guidance
  • UK implementation
  • Brexit

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.

A worldwide problem, for developed and developing countries alike, is the trade of falsified medicinal products. The terms ‘falsified medicines’ and ‘counterfeit medicines’ are not interchangeable—falsified medicines refers to fake products designed to mimic actual medicines, whereas counterfeit medicines refers to products that infringe trademarks or other intellectual property rights.

In January 2013, Directive 2011/62/EC on the prevention of the entry into the legal supply chain of falsified medicinal products (Falsified Medicines Directive or FMD) became applicable. It is implemented in the UK by the Human Medicines (Amendment) Regulations 2013, SI 2013/1855.

Falsified Medicines Directive

The FMD acknowledges an alarming increase of medicinal products detected in the EU which are