On 3 May 2017, the Dutch Council of State upheld a EUR12,000 fine against Biodent B.V. (Biodent) for preparing, storing and marketing a medicinal product (EC40) against caries without authorisation. Biodent’s appeal that the product does not qualify as a medicinal product within the meaning of the Dutch Medicines Act and Directive 2001/83/EC was denied by the Council of State.
The Council of State confirmed that EC40 is a medicinal product based on both the presentation and administration criteria. According to the Dutch Medicines Act and Directive 2001/83/EC, a substance can be considered as a medicinal product based on its presentation or its effect.
First, according to the Council of State, the packaging of EC40 comes across to the average consumer as the package of a medicinal product. Also, the product is supplied with instructions for use, its distribution is mainly limited to dentists and dental hygienists, and the product is delivered by way of syringes and capsules; these facts contribute to the conclusion that the product is presented as a medicinal product that has a therapeutic or prophylactic effect.
Second, the Council of State held that the active substance chlorhexidine, which is present in EC40, kills caries-causing streptococcal bacteria, and that EC4O has a pharmacological, physiological and prophylactic effect on the infectious disease caries.
Consequently, according to the highest administrative court, Biodent had failed to comply with laws concerning the preparation and marketing of a medicinal product because a marketing authorisation is required for the preparation, storage and commercialisation of EC40.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2017 Issue (Thomson Reuters).