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EU adopts counterfeit medicine amendments

Decision could have 'major' impact on medicinal product makers; further discussion planned for May 19-20 European GMP Conference in Germany.

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In mid-February, European Compliance Academy reported that the European Union Parliament adopted the amendments on Directive EC 2001/83/EC to combat counterfeit medicines. The proposed amendments, said the report, “will have to be transferred into national law within two years.”

European Compliance Academy says, “The New Directive on Counterfeit Medicine will have a major impact on everyone involved in manufacturing and quality assurance of medicinal products, APIs, and Excipients. The ECA [European Compliance Academy] plans to cover this important development at future conferences,” including the 4th European GMP Conference, May 19-20 in Heidelberg, Germany. Presenters from Switzerland, Denmark, Germany, the United Kingdom, France, and China will serve as speakers and moderators at the event.