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.

The definition of a falsified device can be found in Article 2(9) of Regulation (EU) 2017/745 on medical devices and Article 2(10) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices:

[A] ”‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;”

An indication of falsification may be inadequate labeling (see: What labeling must a medical device have?)
 

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.

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.

In the case of falsified medical devices, it can be assumed that the safety and performance of the product has not been proven. For example, counterfeit condoms may not provide the claimed protection, or counterfeit contact lenses may not meet the microbiological safety requirements. Furthermore, there is a risk that inferior components have been used in falsified devices, which could due to their lack of biological compatibility be harmful to one’s health.

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):

• European Medicines Agency

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:

• Full List of WHO Medical Product Alerts