Fimea has classified BioNix, containing benzyl benzoate, as a veterinary medicinal product in Finland

BioNix 500 ml Eclipse Biofarmab, intended for treating horses’ skin, is classified as a veterinary medicinal product in Finland. The Finnish Medicines Agency Fimea decided on the classification of the product on 2 September 2024. The decision is not yet final.  

Fimea launched the product classification process in spring 2024 when it emerged that BioNix, a product intended for horse care, was used against the instructions for treating scabies in adults and children.  

Non-compliant product use or the use of veterinary products for human consumption poses a health risk. Over-the-counter creams are available from pharmacies for the treatment of scabies in humans. They contain permethrin or benzyl benzoate and disulfiram, the latter of which was released on the Finnish market in the summer. Alternatively, a doctor may also prescribe tablets containing ivermectin, which are available by prescription only. 

BioNix meets the criteria for a veterinary medicinal product 

BioNix 500 ml Eclipse Biofarmab meets the definition of a veterinary medicinal product based on its effects and its original presentation.  

The product contains a significant amount of benzyl benzoate, a well-known medicinal substance, which produces the pharmacological effect referred to in pharmaceutical standards to treat diseases. This medicinal substance is used in veterinary medicines in the EU because of its effect of killing external parasites, such as itch mites and ear mites.  

The original presentation of the product for the treatment of horses’ summer eczema has been considered to be a treatment of a disease. Summer eczema is a seasonally recurring allergic skin disease in horses, the typical symptom of which is itching and the resulting skin damage and dermatitis. The product was also claimed to reduce the growth of bacteria on the skin and to reduce skin irritation and itching.  

Marketing authorisation is required for veterinary medicines 

A marketing authorisation from Fimea must be applied for veterinary medicines. In the marketing authorisation process, Fimea assesses the efficacy, safety and quality of the product. The veterinary medicine may only be introduced to market after the marketing authorisation has been granted. Veterinary medicines may only be provided by pharmacies and veterinarians in Finland.  

A product classified as a veterinary medicine must not be marketed as a biocide or as a free trade product. The importer is responsible for the product they have imported, for its sales and for selecting the correct sales channel.  

The importer is also responsible for removing a product classified as a medicinal product from the shops selling the product. Supervisory authorities may intervene in unlawful sales of a product. 

Under the Medicines Act, Fimea is responsible for deciding whether a substance or a product is to be classified as a medicinal product, if necessary. The classification is done on a case-by-case basis for each product, based on an assessment of its composition and indication. 

Basis for classifying a product as a medicinal product (fimea.fi) 

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