Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients.
However: With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain. Thus, in the annual “Operation Pangea”, an international week of action for combating the trafficking of illegal drugs on the internet coordinated by Interpol, more than 50,000 websites were shut down in the years 2011 to 2016 alone.
With the EU’s counterfeit protection directive 2011/62 / EU Falsified Medicine Directive, (FMD) and the Drug Supply Chain Security Act (DSCSA), the European Union and the United States have adopted a comprehensive legal framework for greater patient protection and set the stage for even greater pharmaceutical security.
This paper describes the essential regulations in both legal frameworks and the resulting requirements for pharmaceutical companies.
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