What are falsified medicinal products?

According to the definition given by Article 1 of the Directive 2011/62/EU, a falsified medicinal product is “any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used”.

Are all falsified medicinal products dangerous?

YES, all falsified medicinal products are dangerous because they usually lack the correct ingredients or contain sub-standard or falsified ingredients. Those products could also contain ingredients, including active substances, in the wrong dosage.

What is the size of the problem?

The extent of the problem is impossible to quantify, but there is no doubt that it is an everyday phenomenon in every country of the world, and that it is increasing.

What is the percentage of falsified medicinal products in the total number of medicines sold on the Internet?

There are legal, illicit/rogue, and entirely fake pharmacies on the Web. Recently, numerous independent research studies have shown that, in over 50% of cases, medicines sold online are falsified.

Is the problem of the falsification of medicinal product mainly an economic problem to do with copyrights and patents?

NO, the falsification of medicines is not just a problem regarding copyrights or patents, or economic losses for a trademark. It is also a more serious problem for public health.

“More than 94% of online pharmacies are not legitimate”






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With the financial support of the Prevention of and Fight against Crime Programme
European Commission - Directorate-General Home Affairs

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