Does your product need an authorisation from the Danish Health and Medicines Authority?
If you indicate (on the package, in advertising material, etc.) that your product has properties for treating or preventing disease in humans or animals, the product is by definition a medicinal product, which must be authorised by the Danish Health and Medicines Authority.
By definition, a product is a medicinal product if it presented as a suitable product for the treatment or prevention of disease in human beings or animals.
Section 2(i)(a) of the Danish Medicines Act.
In assessing whether a product is presented as a medicinal product we look at:
Claims made for the product – oral and written descriptions used in advertising material,
Marketing – advertisements, brochures and website.
Text and images on the package – label, instructions for use and container,
Comparison to already approved medicinal products,
The name of the product – suggestions in the name, e.g. "Influ-stop",
The product form – does the product look like a medicinal product, food supplement or something completely different,
Disease – is the product to used for a specific disease.
List of diseases and symptoms of disease
It is not always easy to assess what is meant by the word 'disease' in the legal texts. The Danish Health and Medicines Authority has therefore compiled a guiding list of diseases covered by the definition of what is a medicinal product.
If your product works against one of the diseases on the list, it is most likely a medicinal product, which must therefore be authorised by the Danish Health and Medicines Authority.
The Danish Health and Medicines Authority sees companies that do not abide by the law when advertising their products. One such example is when a product is advertised as having properties for preventing gout, but is not authorised as a medicinal product.
In this context, adverting means any presentation of the product, i.e. product designation, the way it is displayed, product recommendations, etc. on packaging, product description supplied with the product, mention of the product on the company website, etc.
Once a medicinal product, always a medicinal product
Once the Danish Health and Medicines Authority has determined that a product is a medicinal product, the status of the product cannot be changed later on, not even if the company changes the way it presents the product. Rewriting the advertising material, etc. will not change the intended purpose of the product.
If the company wants to continue selling the product legally, it must seek authorisation to market the product from the Danish Health and Medicines Authority.
Marketing under other legislation
The company is allowed to introduce a similar product on the market later on, for example as a food supplement, provided that both the marketing material and product name are changed. The new product must not lead the consumer to link it with the old product, and the company is not allowed to compare the products in its marketing material, which means that utterances like "the successor with the same good effect" are not allowed.
If a product is determined to be a medicinal product based on its active substance, any new product containing the same active substance will also be classified as medicinal product.