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Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. Between 2013 & 2017 the European Commission received 400 notifications of falsified medicines.


EDC News: Falsified Medicine: new rules to enhance patients’ safety

In 2017, almost €7 million of falsified medicines were confiscated at the EU borders by Interpol, Europol and national medicines agencies. Falsified medicine is hard to identify due to the increased sophistication of tampering techniques, not going through obligatory checks and its ability to access legal supply chains due to complex distribution networks.


In order to simplify the identification of the falsified medicines, the EU has adopted the Falsified Medicines Directive (DIR 2011/62/EU). It outlines safety characteristics for prescription medicine packaging, e.g. unique identification code for authentication and an anti-tampering device. Moreover, in order to control the supply chain and who contributes to it, the directive includes stricter rules on the import of active pharmaceutical ingredients (DIR 2001/83/EU) (Implementing Decision 2013/51/EU), as well as, improving record-keeping requirements for wholesale distributors. In addition, the European Commission has developed a logo, which is used to identify legal online pharmacies (Implementing Regulation 2014/699). All prescription and over the counter medicines to be sold on the EU market must adhere to safety measures outlined in the Commission Delegated Regulation 2016/161. To limit the number regulation infringements, all EU Member States are required to set and implement penalties for those violating national laws (based on DIR 2001/83/EU). The Commission has created a report that includes an overview of the penalties of each EU country along with a qualitative assessment of their effectiveness; this report was given to the European Parliament and Council in January 2018.


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