The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional safety features, as well as the repository system that will allow the verification of authenticity of individual packs of medicine, may threaten the availability of medicines.
Maarten Van Baelen, Pieter Dylst, Catarina Lopes Pereira, Johan Verhaeghe, Koen Nauwelaerts, Susie Lyddon
Medicines for Europe Director General Adrian van de Hoven participated in the Open Public Hearing (OPH) of the July 13, 2017 Oncologic Drugs Advisory Committee US FDA Advisory Committee involving biosimilar medicines on 13 July 2017.