The study gathered information on, analyses and critically assesses the transposition measures undertaken by Member States in relation to Art. 118a of Directive 2001/83/EC concerning the entry of falsified medicinal products into member state health systems. Strict rules should ensure that medicines are safe and that the trade in medicines is rigorously controlled. The study identified all national measures which transpose, implement and enforce Article 118a of Directive 2001/83, assessed them with respect to their effectiveness, and developed recommendations to improve the achievement of the objectives of the Directive. The study report has been published in January 2018.
Study on the Transposition measures of Member States in relation to the pharmaceutical legislation
DG SANTE, European Commission (EC)