What are falsified medicinal products?
The German Medicinal Products Act regulates what is classified as a falsified medicinal product and what is classified as a falsified active substance:
A falsified medicinal product is any medicinal product with a false representation of
- its identity, including its packaging and labelling, its name or its composition as regards one or several of its constituents including excipients and the strength of those ingredients;
- its source, including its manufacturer, its country of manufacture, its country of origin or its marketing authorisation holder; or
- distribution channels described in the related records and documents.
A falsified active substance is an active substance for which the labelling on the container does not correspond to the actual content or the accompanying documents fail to reflect all of the manufacturers involved or the real channels of distribution.
In particular, the internet has been shown to be an important gate for falsified medicinal products. You can find more about buying medicinal products via the internet here.
How does InphA help?
Competent authorities, customs and law enforcement agencies instantly act on evidence of falsified medicinal products or illegal import of medicinal products. These authorities, if required, commission tests at InphA.
Our staff is specialised in testing and determining falsified medicinal products. We use specially developed screening methods if there is the suspicion of a falsified medicinal product. Doing so, we often discover substances not mentioned on the package, as the following example shows.
Exemplary test result
The figure shows the chromatogram of an internet-marketed slimming aid which is claimed to only contain herbal substances. However, the two drugs sibutramine and phenolphthalein were found, both substances for weight reduction. For the consumer, taking this slimming aid can have serious side effects.
Consumer information and awareness raising
Authorities and media inform regularily on this topic:
- Information sheet of the Federal Ministry of Health: “Information sheet falsified medicinal products”
- Information sheet of the Federal Ministry of Health: “How to protect yourself from falsified medicinal products”
Warnings by the authorities
Article in the German pharmacists’ magazine:
“Customs investigation warning about falsified medicinal product somatrope”
Events, press & publications
Below are some examples of the contributions of InphA to consumer protection:
- NDR and SZ: “The tricks of the slimming industry ”
- Press clip by Pressedienst Bremen about the work of InphA in this field: “Life threatening in the worst case ”
- Publication based partly on results of testing performed by InphA: “Sibutramine in Chinese slimming capsules”