Falsified Medicines Directive Legislation

The European Commission's Directorate for public health and risk assessment have issued Directive 2011/62/EC and guidance from (2001/83/EC ) 2001.

The Directive’s main aim is to protect patients from the threat of falsified medicines. As the risk to public health and safety increases every year, the European Council has introduced a comprehensive, harmonised and pan-European strategy across all member states.