Falsified medicines
Produced in partnership with Elisabethann Wright of Cooley LLP and Fabien Roy, Jane Summerfield, Alexander Wenzel, Hélène Boland, Hannah Kerr-Peterson, Jessica Koffel and Silvia Lopez Arnao of Hogan Lovells

The following Life Sciences practice note produced in partnership with Elisabethann Wright of Cooley LLP and Fabien Roy, Jane Summerfield, Alexander Wenzel, Hélène Boland, Hannah Kerr-Peterson, Jessica Koffel and Silvia Lopez Arnao of Hogan Lovells provides comprehensive and up to date legal information covering:

  • Falsified medicines
  • EU regulatory framework—Falsified Medicines Directive
  • The Withdrawal Agreement
  • The EU-UK Trade and Cooperation Agreement
  • UK regulatory framework
  • What is a falsified medicine?
  • Controls on active substances
  • Obligations on various actors in the supply chain
  • Manufacturers
  • Wholesale distributors
  • More...

Falsified medicines

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.

This Practice Note explores the changes introduced to the regulation of medicinal products by Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products (Falsified Medicines Directive or FMD) to combat the increase in the incidence of falsified medicines. First, the Practice Note considers what is meant by the term ‘falsified medicinal product’, before looking at the measures introduced by the FMD: greater control of active substances, obligations for actors in the supply chain, the introduction of safety features on the packaging of medicinal products and the common logo for websites selling medicinal products. This Practice Note provides an overview of both the EU and UK regimes for falsified medicines.

EU regulatory framework—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. Therefore the FMD, which became applicable in the EU in January 2013, amended Directive 2001/83/EC, the Pharmaceutical Code, by introducing measures aimed at combatting falsified

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