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Falsified medicines

What are ‘falsified medicines’?

Falsified medicines are fake 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 – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy – as required by strict EU authorisation procedures, they could be detrimental to the health of patients who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

To date, the only counterfeit or fake medicines detected in Croatia have been bought from illegal websites, however, there have been reports of fake medicines coming through legitimate supply channels in other countries including Norway and the UK, and so the risk cannot be ignored.

How does the Falsified Medicines Directive tackle this threat?

The EU adopted 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.

Letter to stakeholders

A key measure to address falsification in the EU and protect the legal supply chain of medicines is an end-to-end verification system introduced by the Falsified Medicines Directive (FMD).

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Amount of the annual fee

HOPAL determined the amount of the annual fee for the Croatian Medicines Verification System usage by MAHs
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The Croatian Medicines Verification Organisation (HOPAL) is a non-profit organisation representing the different stakeholders, both...
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Croatian Medicines Veryfication Organization
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