The falsification of medicines is a serious threat to public health. Falsification affects a wide range of medicines, such as cancer, sexual dysfunction and Hepatitis C treatments. Falsified medicines can and do penetrate the legal supply chain, as seen with the discovery in 2014 of falsified vials of the cancer treatment Herceptin (trastuzumab) in multiple EU markets
In 2011, the European Parliament and the Council adopted Directive 2011/62/EU2 (the Falsified Medicines Directive) to amend Directive 2001/83/EC3 and address increasing concerns regarding falsified medicines in the legal supply chain.
The Falsified Medicines Directive introduces mandatory safety features on prescription medicines from February 2019 (unless explicitly exempted), strengthens good distribution practices and requirements for wholesale distributors, reinforces rules on importation, controls and inspections of active substances and their manufacturers, and establishes an EU-wide logo to allow the identification of legal online retailers of medicines (applicable from 1 July 2015)