Natural medicinal products

Updated 05 September 2017

Natural medicinal products are a special group of medicinal products that typically contain dried plants or plant parts, plant extracts or other naturally occurring substances.

Danish law defines natural medicinal products as "medicinal products whose active substances are only naturally occurring substances in concentrations that are not significantly higher than those found in the environment".

Natural medicinal products are sold freely, which means that they are not restricted to sale at pharmacies. Since neither a doctor nor a pharmacist needs to be involved in the treatment, natural medicinal products can only be approved for treatment of "minor diseases".

Natural medicinal products must be approved by the Danish Medicines Agency before they can be sold in Denmark. The Danish Medicines Agency imposes requirements on the manufacture, quality, safety and efficacy of natural medicinal products.

Manufacturers of natural medicinal products and manufacturers of ordinary medicines must fulfil the same requirements. Some of them include requirements for the layout of premises, raw materials and product control. The quality criteria ensure that natural medicinal products are manufactured from well defined raw materials and that the product satisfies requirements for homogeneity and durability.

The safety and efficacy requirements are based on the scientific literature available for the medicinal plant or extract and not necessarily on specific clinical studies of the individual product.

The label on natural medicinal products must carry the statement "natural medicinal product" to let the consumer know what type of product it is. The package leaflet inserted in the package gives further details on how to use the natural medicinal product.

Summaries of product characteristics

Summaries of product characteristics for natural medicinal products

Marketing authorisation

Guidelines for marketing authorisation for natural medicinal products

List of licensed natural medicinal products and traditional herbal medicinal products (Excel file) (updated daily)