The EU Directive on Falsified Medicines (Directive 2011/62/EU) was published in July 2011. It reflects an increasingly complex distribution network for medicinal products, with many different players – and a pressing need to ensure reliability across the entire supply chain.
Harmonized safety features across the entire EU are on their way. Legislation will be in force by the end of 2015, and manufacturers and other stakeholders will then have three years to decide on and implement a range of different safety features. It means new responsibilities for wholesalers and brokers, with written confirmation needed for APIs (active pharmaceutical ingredient) manufactured outside the EU and logos for legally operating online pharmacies.
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