MTD-Verlag GmbH Danger of warnings when selling via the Internet

(06/2022) Johannes Richard, specialist lawyer, lawyers Richard Kempcke

If the medical technology specialist retailer XY sells disinfectants via an online shop, the risk of a warning – unknown to many – is quickly on board. The legal assessment revolves around one question alone: is the product a biocide or a medicinal product? Depending on how the question is answered, different legal obligations apply.

There is a treacherous warning trap when selling disinfectants over the Internet: From a legal point of view, a disinfectant can either be a medicinal product or a biocide. The disinfectant Sterillium is offered as a medicine and as a biocide. Depending on the product in question, there are different obligations when selling over the Internet.

In order to check what kind of product it is, it is advisable to look on the manufacturer's website. In addition, the labeling of pharmaceuticals and biocides differs significantly:

• In the case of a medicinal product, the packaging or the accompanying documents mention “active substance” and “interactions with other substances” as well as “side effects”, and there may also be a note “medicinal product – keep out of the reach of children”.
• A biocide does not contain this information, but a registration number beginning with the letter N from the Federal Institute for Occupational Safety and Health (BAuA).

Pursuant to Section 67, Paragraph 8 of the Medicines Act, there is an obligation to register with the competent authority before selling over-the-counter medicines on the internet. There is also an obligation to display the so-called EU security logo on the website. The logo must be linked to the dealer's register entry on the website of the Federal Institute for Drugs and Medical Devices.

There is a completely different information obligation when offering biocidal products in accordance with Art. 72 of Regulation (EU) No. 528/2012. There is an obligation to clearly include the following warning in the item description: "Use biocidal products carefully. Always read the label and product information before use.” There is also an obligation to include the BAuA registration number in the item description.

Both the offer of medicinal products without registration under the Medicines Act and display of the mail order logo and the offer of biocides without display of the warning notice can be anti-competitive. sow