European Union


Authority: EU Commission

Request Source: Regulation

Data Carrier: GS1 Data Matrix

Details: The European Medicines Agency (EMA) published the Counterfeit Medicines Directive (FMD) in 2011 and it has started to determine the traceability standards of the countries under the umbrella of the European Union. Since 2019, all drugs manufactured have been required to fully meet their FMD obligations. The European Medicines Verification Organisation (EMVO) is a non-profit legal organization, which is established by the pharmaceutical industry stakeholders of the European Union. Drug manufacturers, wholesalers, pharmacies, and hospitals should perform drug verification and notification processes to the central system controlled by EMVO. Besides, EU countries with a different system, such as Greece, and Italy, must fully comply with the regulation on medicine monitoring practices by 2025.


Europe Regulations

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