What are "counterfeit medicines"?
In general, products, such as jewellery, works of art or designer articles, are counterfeited to make money. All forgeries have one thing in common: They pretend to be something they're not. However, what means counterfeiting in the context of a medicinal product (or medical device)?
The definition of a counterfeit medicinal product can be found in the Austrian Medicines Act (Arzneimittelgesetz - AMG) under § 1 para. 25:
"Counterfeit medicinal product" means any medicinal product for which any of the following have been counterfeited:
1. its identity, including its packaging and labelling, its name or composition in relation to any constituent, including excipients and the content of those constituents; or
2. its origin, including the manufacturer, country of manufacture, country of origin and marketing authorisation or registration holder; or
3. the records and documents relating to the distribution channels used.
Drug counterfeiting is not only the case if the medicinal product itself, i.e. the tablet, capsule, ointment, etc., has been counterfeited, but also if any component of the product or the associated documents has been manipulated with regard to its manufacture and distribution. If, for example, an expired original product is repackaged in a counterfeit packaging with a different expiry date, or if the delivery documents of a preparation originating from Romania are manipulated in such a way that it looks as if the product had been manufactured in Austria, this is also referred to as counterfeit medicinal product.
The definition of al legally compliant medical device can be deduced form § 15 para. 2 of the Austrian Medical Devices Act; here you can find a definition of the criteria necessary to make a medical device legally conformant.
What is an illegal drug?
Illegal medicines are products that are manufactured and sold outside the legal requirements. This also applies, for example, if a drug is sold in Austria without Austrian marketing authorisation, even though it is an original preparation. However, illegal medicines are often also counterfeit. Counterfeits are not subject to any quality controls during their production. They are sold with unknown quality, unchecked and illegal. The contents of these products is not known. Due to their unknown composition and possible impurities, they can be completely ineffective, harmful or even life-threatening.
The detection of counterfeit drugs is very challenging or almost impossible, as the appearance of counterfeits is often difficult to distinguish from the original product. You should therefore buy your medicines only from legal, public pharmacies. The strict requirements for the distribution of pharmaceuticals ensure that you do not buy counterfeits.
What can happen if I take a counterfeit medicine?
At best, nothing happens. However, if you treat a serious illness with counterfeit medicines, you can suffer from grave consequences. For example, ineffective antibiotics or antibiotics that are too low in dosage can lead to a higher resistance of bacteria in the long term. Diseases can spread or worsen without proper treatment. There is also a risk that illegal drugs may be contaminated with toxic substances or other active ingredients, which can be harmful to your health.
Where can I learn more about counterfeit medicines?
The Enforcement Division offers information on current cases of illegalities in the field of human and veterinary pharmaceuticals and medical devices (read more).
Further information on counterfeit medicines can also be found on the homepage of the European Medicines Agency (EMA):
On the homepage of the World Health Organization (WHO) you will find a continuously updated list of warnings on products for which safety deficiencies have been found. Read more: