Improving the
safety of medicines

Falsified Medicines Directive

Falsified medicines are medicines that pass themselves off as real, authorised medicines. The term ‘falsified’ refers to all forms of falsification, while the term ‘counterfeit’ specifically refers to an infringement of intellectual property rights.

Falsified medicines may contain ingredients, including active ingredients, which are of poor quality or in the wrong dose; they may contain too much or too little of the active ingredient. This happens since they have not been properly evaluated to check their quality, safety and efficacy as required and directed by strict EU authorisation procedures. Thus, they could be detrimental to the health of people who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

Although falsified medicines have not been found to be common in Malta, there have been reports of fake medicines coming through legitimate supply channels in other countries, and so the risk cannot be ignored.

How does the Falsified Medicines Directive tackle this threat?


The EU passed legislation in 2011 – known as the Falsified Medicines Directive (Directive 2011/62/EU) – to prevent falsified medicines infiltrating the legal supply chain and ultimately from reaching European patients. Measures to tackle the threat include:

  • A requirement for medicine packs to carry special safety features in the form of an anti-tamper device (e.g. foil seal, breakable cap) and a barcode containing ‘unique identifiers’ (including a serial number) to enable the authenticity of the pack to be checked prior to dispensing.
  • A common, EU-wide logo to identify legal online medicines suppliers, making it easier to distinguish them from illegal operators.

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  • June 4, 2019
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  • November 30, 2018
    Meeting for pharmacy owners and managing pharmacists (L to Z)
  • November 30, 2018
    Meeting for pharmacy owners and managing pharmacists (A to K)
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