According to the European Commission (hereinafter ‘EC’) of the European Union (hereinafter ‘EU’), the threat to public health and safety from falsified medicinal products is on the rise:

‘Falsified medicines […] are a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.’1 In order to control and combat the threat mentioned, the EC has introduced new legislation to put in place preventive measures to improve the protection of the public. The basis for this new legislation was defined in the Directive 2011/62/EU2 (hereinafter: ‘Directive’), amending Directive 2001/83/EC3 (hereinafter: ‘the original Directive’).

Following adoption by the EC and the European Parliament, the new legislation on falsified medicinal products was published on 1 July 2011 in the Official Journal of the EU. This new legislation came into force on 2 January 2013 and introduces new harmonised EU-wide measures to ensure that medicinal products are safe and that the trade in medicines is rigorously controlled. In order to expand on this basis, the EU has launched a concept paper and set out public consultations4 on a number of different topics with the EU member states. The responses from these public consultations will be used as discussion points when the EC prepares the delegated acts, which serve as a minimum requirement for adoption of the Directive into the national laws and regulations of the EU member states.

The remainder of this chapter will set out the objective of this report and the approach taken in developing this report.

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