EU Pharma Law

Does EC40, a chlorhexidin lacquer to prevent tooth decay, qualify as a medicinal product or not?


The Dutch Minister of Healthcare decided that EC40, a lacquer containing chlorhexidin used for the purpose of preventing tooth decay, should be regarded as both a medicinal product by presentation as well as a medicinal product by function and imposed an administrative penalty of €12.000, since the company (Biodent) (i) prepared the product, (ii) had the product in stock and (iii) marketed it without a marketing authorisation. According to the information leaflet, EC40 ensures a “long-term suppression of the cariogenic mutant streptococcus on the treated teeth parts”. The highest administrative court of the Netherlands, the Council of State, aligns with the judgment of the District court that EC40 should be qualified as a medicinal product by presentation as well as a medicinal product by function. Please find the judgment and my annotation here (only in Dutch).