Falsified medicinal products

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

  1. 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;
  2. its source, including its manufacturer, its country of manufacture, its country of origin or its marketing authorisation holder; or
  3. 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.

Falsified medicinal products

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:

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:

back to the top