EU publications

Study on the transposition measures of Member States in relation to the pharmaceutical legislation (Art. 118a of Directive 2001/83/EC)

Final report - Study

Publication metadata

In 2011, to address the threat of falsified medicines, Directive 2011/62/EU amended Directive 2001/83/EC to include measures aimed at preventing the entry of falsified medicinal products into the legal supply chain. Article 118a of the Directive includes the requirement for Member States (MS) to introduce penalties related to the falsification of medicinal products, active substances and excipients. This report outlines the measures in place or taken by Member States to transpose, implement and enforce Article 118a of the Directive and gathers and assesses relevant information regarding the... effectiveness of those measures. It includes: The penalties in place in each Member State ; A Member States overview with respect to these measures ; An assessment of the effectiveness of the measures ; Recommendations on improving the achievement of the objectives of Article 118a. The study gives an overview of the situation in the EU in mid-2017 and should feed into the Commission Report to be sent to the European Parliament and Council in January 2018. In any case, Member States should have notified the European Commission of the national provisions adopted by January 2013.