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
  • Safety features
  • The Implementation Plan and EU guidance
  • EU common logo for online sales of medicines
  • Brexit

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 was implemented in the UK by the Human Medicines (Amendment) Regulations 2013, SI 2013/1855.Directive 2011/62/EC, the Falsified Medicines DirectiveHuman 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 falsified and reach patients through illegal means and via the legal supply chain alike. The FMD therefore amends Directive 2001/83/EC (consolidated version 16.11.2012), the Pharmaceutical Code, which is implemented in the UK by the Human Medicines Regulations 2012 (HMRs), SI 2012/1916, by introducing measures aimed at combatting falsified medicines.Human Medicines Regulations 2012, SI 2012/1916Recital 2 of Directive 2011/62/EC, the FMDDirective 2001/83/EC (consolidated version 16.11.2016), the Pharmaceutical Code

Such measures include:

  1. rules on the controls and inspections of producers of active pharmaceutical substances

  2. increased obligations for various actors in the supply chain, for example, brokers and record-keeping requirements for wholesale distributors

  3. obligatory safety features, such as unique identifiers (UIs) and anti-tampering devices, on the outer packaging of the medicines to allow the verification of the authenticity of medicinal products subject to prescription

  4. an EU-wide logo to identify legal online pharmacies, making it easier to distinguish between legal and illegal online