Serialization of pharmacetical products: Eu delegated act 2016/161 to protect against falsified medicines (review)
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2019-01-01
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Abstract
The European Union's Falsified Medicines (FMD) Directive 2011/62/EU modifies Directive 2001/83/EC to ensure public health by protecting the pharmaceutical supply chain from infiltration by counterfeit medicines. It also introduces new rules to regulate more strictly the supply chain. The Commission Delegated Regulation (EU) 2016/161 completes Directive 2001/83/EC with detailed rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015 and published in the Official Journal of the European Union in February 2016, and came into force at the end of February 2019. This article will provide an overview of the directive, its impact on the distribution of medicines, and the latest update affecting pharmaceutical manufacturers.