This week, the EU has issued a new directive outlining regulations
intended to help prevent counterfeit drugs from entering the legitimate
supply chain. The new requirements include mandatory features on drugs’
outer packaging, strengthened requirements for inspection of the
pharmaceutical ingredient manufacturers, and stepped-up enforcement of
manufacturers’ and distributors’ obligation to report any suspicion of
falsified medicines. The European Medicines Agency (EMA) issued a
statement welcoming the rules, and said the agency would be working
closely with the European Commission over the next 18 months to
implement the legislation. The directive is scheduled to come into force
later this month with full compliance by all Member States by January
2013.
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