Falsified medicines are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at the European and international level.

With the Falsified Medicines Directive and its supplementing Delegated Regulation (altogether ‘FMD’) the legislator has taken the necessary steps to prevent falsified medicines from entering the legal supply chain. One of the measures that is being undertaken to achieve this goal is to mandate pharmaceutical companies and parallel distributors of mainly prescription medicines to apply safety features to their outer packaging. This guideline provides all manufacturers [Marketing Authorisation Holders (MAHs)] and Parallel Distributors with assistance in the upcoming implementation of the required measures for protection against falsification and describes in detail the On-boarding Process to the pan-European system against falsified medicines.