How to Fight Pharmaceutical Counterfeiting
In June 2011, the European Union published its Directive 2011/62/EU. In addition to the introduction of serialization standards for prescription medicines, the directive initializes the search for appropriate safety features. It also provides for stricter regulations regarding the import of active substances and the improved control of the supply chain, including wholesale. Regulations for Internet trading of medicines, the harmonization of Good Manufacturing Practice (GMP) inspections and the introduction of a pan-European early warning system are also an integral part of this Directive.
Moving in the Right Direction
Uniquely coded, serialized packs for almost all prescription drugs are the Directive’s most important component. But the EU also recognizes the need for a combined strategy and requires a second layer of security, that is tamper-proof closures. These security components will be obligatory for nearly all prescription drugs, but not for OTC drugs. The required safety feature – the so-called ‘unique identifier‘ – will be determined in delegated acts, whose aim is to define the characteristics and technical specifications of the unique identifier, as well as the modalities of verification and the establishment, management and accessibility of the repositories system (database).
It will be some time until all required steps are implemented and harmonized on an international level but as of now the industry is clearly moving in the right direction in its fight against pharmaceutical counterfeiters.