Is pharmaceutical authorisation required for antibacterial mouthwash?

The Regional Court (LG) Cologne had to decide whether pharmaceutical authorisation is required for the distribution of a mouthwash with antibacterial properties or whether the mouthwash may be sold as a cosmetic product without authorisation.

The parties are competitors in the distribution of antibacterial mouthwashes. Whilst one competitor sells its product as an authorised but non-prescription pharmaceutical, its competitor brings a product containing the same antibacterial substance onto the market without pharmaceutical authorisation.

Following a cease-and-desist letter and demand to cease distribution without authorisation, proceedings were brought before the Regional Court (LG) Cologne.

Court decision

By judgment of 16.05.2013 – Az. 31 O 541/12 – the Regional Court (LG) Cologne ordered that distribution of the product sold without pharmaceutical authorisation be discontinued.

The LG Cologne established that the mouthwash in question was a pharmaceutical, as the antibacterial active substances in the product had a so-called pharmacological effect. This is always the case when an active substance has an influence on physiological functions of the human body. Distribution of the product in dispute without authorisation was therefore unlawful.

Conclusion

The distinction whether a product requires authorisation as a pharmaceutical or may be distributed as a cosmetic product without such authorisation has numerous practical consequences. Pharmaceutical authorisation requires several time-consuming and costly clinical trials and has significant disadvantages in distribution, since pharmaceuticals must be advertised more restrictively than cosmetic products.