The Falsified Medicines Directive 2011/62 / EU (FMD) came into full force in February 2019.
Falsified medicines represent approximately 1% of medicines sold in developed markets, and the global market for counterfeit pharmaceuticals is worth US$200 billion per year*.
​
In Luxembourg, we have been protected from these incidents for the time being and we are doing everything we can to prevent such situations.
​
Because patient safety is of the utmost importance for the European Union, the EU commission has introduced, in consultation with each member state, the Directive 2011/62/EU to prevent falsified medicines from entering the legal medicine distribution chain. The European Commission has also published the operational specifications for the implementation of security features with the Delegated Regulation (EU) 2016/161 . Luxembourg transposed it in its Grand-Ducal Regulation of 13 January 2019 Official Journal of the Grand Duchy of Luxembourg (public.lu)
These measures aim to put a definitive end to the dangerous trade in falsified medicines practiced throughout the world and which represents an unacceptable threat to human health.
To date, no falsified medicine has been introduced into the legal medicine distribution chain in Luxembourg and pharmacies (dispensary and hospital) constitute, thanks to this system, the safe distribution channel for medicines.
​
*Pharmaceutical Serialization: Compliance and Beyond, EY, 2016
About EMVO
The European Medicines Verification Organization ( EMVO ) is a non-profit organization that represents the various players in the legal distribution chain for medicines in Europe. EMVO is in charge of the implementation of the European Medicines Verification System ( EMVS ). The EMVS complies with the specifications of the European Falsified Medicines Directive (FMD) and the Delegated Regulation (DR).
