Croatia Included in EU Project for Drug Serialization

Knowing that one in every two drugs purchased online is counterfeit, and that the amount of counterfeit drugs in the global market is increasing year by year, the European Parliament and the European Commission adopted the Directive on Falsified Medicines (Directive 2011/62/EU) in 2011, which obliges all participants in the drug supply chain to introduce safety features in the form of tamper-evident packaging and a unique identifier on every box of prescription medicine starting from February 9, 2019.

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In practice, this means that each individual serialization number of a prescription drug box, including in Croatia, will be entered and available in the European Medicines Verification System, as well as in the national database, allowing for the verification of its origin and authenticity at any time. The goal of the project is to prevent the entry of counterfeit drugs into the legal supply chain, focusing on protecting and increasing patient safety.

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Since the start of operations in September 2017, the Croatian Medicines Verification Organization (HOPAL) has been involved in the serialization project, aligning with the European Medicines Verification System (EMVS). There, approximately 10 billion data points about drug products and packaging are processed annually, which are then available in the National Medicines Verification Systems to verify the authenticity of each drug, regardless of the EU country to which it is delivered.