Falsified Medicines Directive enters into force in Europe in January 2013.
Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC establishing a community code on medical products for human use, regarding the prevention of the entry of counterfeit medicines in the legal supply chain, substantially changing the European framework around the provision of medicines. The new legislation introduces stricter rules to improve the protection of public health with new measures to ensure that the medicines are safe and that the trade in medicines is rigurously controlled.
The provisions of FMD have been taken into consideration in many situations:
- To introduce a new feature of mandatory authenticity ( relative to a security measure) it must appear on the outer packaging of medical products covered.
- To introduce stronger rules regarding the control of materials and inspection of the producers of active substances and excipients contained in the starting medication.
- To enter more robust controls in the wholesale distribution of medicinal, including the introduction of controls for the first time in the entities participating in the negociation of medicines.
- To introduce a common EU-wide logo to identify pharmacies in legal lines and establish a reporting system for entities that offer to supply medicines to the public through internet.