What is classified as a medicinal product is determined by 1 § Medicines Act. Classification is primarily based on two factors: the intended use of the product and its contents. Classifications are based on an overall assessment of each individual product.
Explicit medicinal claims
The claims made about a product are important for its classification. A product stated to possess properties for preventing or treating illnesses is classified as a medicinal product. Such medicinal claims may be implicated by arguments that the product is intended to treat or relieve certain symptoms. Even claims that the product ‘protects’, ‘counteracts/strengthens’ can be considered equivalent to preventing.
Examples:
- Relieves anxiety
- Relieves pain
- Combats eczema
- Improves healing
- Combats impotence
- Combats upset stomach
- Improves resistance to infection
- Strengthens the immune defence
Examples of non-medicinal claims
Under the assumption that the claims are not made in conjunction with, or having implications for, an illness, the following general claims in themselves are not considered medicinal claims.
Examples:
- Softening or antiseptic (cleansing products)
- Relaxing (for massage oil)
- Soothing and refreshing (for throat tablets)
- Aid to slimming (for fibre products)
- Anti-oxidant (for nutritional supplements)
Differentiating between health claims made on foods and medicinal claims
A EU decree on health claims made on foods (1924/2006) has been in existence since 2006. The aim is to create at EU level a list of the health-related claims that can be made for different foodstuff ingredients. The idea is to increase harmonization within the EU and to permit control that the claims made on the market are supported scientifically.
Companies and branch organisations have had the opportunity to submit suggestions for health claims to the National Food Administration. The Medical Products Agency has noted these suggestions and deemed that some of the suggestions are to be considered as medicinal claims. The Medical Products Agency has therefore chosen to list some examples of claims that are considered medicinal. The aim is to help companies become aware of which type of claims can lead to a medicinal product classification.
Since there now exists a decree covering health claims, the Medical Products Agency also wishes to clarify the claims that the agency considers not to be medicinal and that can instead be regulated according to the decree on health-related claims. For more information on the health claims that are permitted for foods, please contact the National Food Administration. To read more about the National Food Administration, see the link on the right.
Implied medicinal intention
The term medicinal product includes products – with or without demonstrable efficacy – that are stated by the seller to have an effect. However, it is not only the direct claim made during marketing that can be crucial for a product’s classification. Even aspects such as the constituent components, the known medicinal use of the product by the general public, the form of the medicinal product, dosage instructions, the product name, etc., can also be significant.
Medicinal product classification due to content
A product that contains substances or combinations of substances with a pharmacological, immunological or metabolic effect is, according to the Medicines Act, normally classified as a medicinal product.
Even products that include substances (including those of plant origin) with a well-known medicinal use are normally classified as a medicinal product. Examples include products that contain ginkgo biloba, valerian, St. John's wort, senna or products that contain melatonin.
The Medical Products Agency even takes into account, for example, the use as a foodstuff, other product legislation, dosages, etc. in its assessment of substances.
An EU decree for Novel food (258/97) was adopted in 1997. This means that if a foodstuff has not been consumed to any great extent within the EU before May 15th 1997, this foodstuff must be approved according to a special procedure before it can be sold in the EU. This means that even products that the Medical Products Agency has classified as non-medicinal products may need approval for sale. Please contact the National Food Administration for more information on Novel foods. Read more about Novel Foods via the link on the right.