Medicinal product or borderline product
Ordinary medicinal products
Medicines contain substances that prevent or treat a disease. According to section 2 of the Danish Medicines Act, a product is a medicinal product if it contains an active substance, or if it is recommended for the treatment of a disease, e.g. in the form of an advertisement or if it is to be used to make a medical diagnosis. It could be products intended to work inside or outside the body, and it could be products for people or animals.
Ordinary medicinal products are divided into two main groups:
- prescription-only medicine covers products that can only be bought on prescription from a doctor. Such medicines are sold in pharmacies.
- over-the-counter medicine can be bought in shops authorised by the Danish Medicines Agency. Besides pharmacies, such medicines are sold in supermarkets and petrol stations, etc.
Before a medicine can be sold in Denmark, it must be authorised by either the Danish Medicines Agency or the European Commission. In the authorisation process, the product's scientific documentation is evaluated. The Danish Medicines Agency also assesses the product's negative qualities, for example side effects and drug interactions. We do this to make sure that the medicines work as intended and are acceptably safe.
Natural medicinal products
Natural medicinal products are a special group of medicinal products that typically includes 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 doses 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.
Traditional herbal medicinal products
Traditional herbal medicinal products are a new group of medicines whose authorised use is based solely on long tradition and experience with the plant or plants. As with any other medicine, traditional herbal medicinal products must be approved before being placed on the market. The approval is based on manufacturing, quality and efficacy requirements as well as on traditional use.
Traditional use means that the product in question has been in medicinal use throughout a period of at least 30 years, of which at least 15 years' use must relate to the European Union.
It must be indicated on the label of traditional herbal medicinal products that the medicine is a traditional herbal medicinal product whose effect has been established solely through traditional use of the herb.
Homeopathic medicinal products
A homeopathic medicine is a medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or by another nationally used pharmacopoeia.
Homeopathy is not based on the ordinary scientific principles of dose-effect relationship, but on a theory developed in the 18th century by German Dr. Hahnemann, suggesting that an extremely diluted substance, created from repeated dilutions, may treat the very symptoms that the substance would produce when taken in normal doses by a healthy person.
In homeopathy, the degree of dilution often follows the decimal scale D, denoting how many times the substance has been diluted ten times. Thus, D6 would indicate that the substance has been diluted ten times its original volume in six stages.
The Danish Medicines Agency imposes requirements on manufacturers of homeopathic products with respect to premises, raw materials, staff competencies, etc. to ensure that products are manufactured in compliance with the special principles that apply to this type of medicines.
In Denmark, homeopathic products cannot be approved with an indication of effect. Homeopathic medicines must be notified to or approved by the Danish Medicines Agency before being placed on the market. The general requirements for homeopathic medicines are described in European Directives.
The label on homeopathic medicines indicates that the product is a homeopathic medicine.
Food supplements are products intended to provide additional nutrients to a normal diet, e.g. ordinary vitamins and minerals. It could also be oils with a high content of essential fatty acids.
Food supplements could also be products that have a physiological effect, e.g. slimming products or stop-snoring products. It could also be products that improve skin, hair and nails or products that improve memory or strengthen the immune system or ease fatigue. However, food supplements do not include products sold to cure diseases, because such products would be classed as medicinal products.
Food supplements must comply with the Danish Food Act and the Danish executive order on food supplements. Food supplements need not be approved before marketing, but all food supplements must be notified to the Danish Veterinary and Food Administration for registration.
You can read more about food supplements at the website of the Danish Veterinary and Food Administration.
Animal feed is compound feeds, such as complete feeds, complementary feeds, mineral feeds, milk replacers, molassed feeds, dietetic feeds as well as the ingredients contained in these compounds.
Compound feeds are composed of feed materials such as cereals, soybean meal, feed salt and hay as well as feed additives like vitamins and trace elements. The Danish Plant Directorate administers the legislation in the area of animal feed and monitors compliance with the law.
You can read more about animal feed at the website of the Danish Veterinary and Food Administration.
Biocides is a collective term for chemical substances designed to control harmful organisms, algae, bacteria, fungi in woodwork, etc. The Danish Environmental Health Protection Agency administers the biocides authorisation scheme pursuant to the provisions of the Danish Act on Chemical Substances.
If a biocide is to be authorised in Denmark, three important criteria must be satisfied:
- It must not be harmful to the health of human beings or animals,
- It must not be detrimental to the environment,
- It must be sufficiently effective for the purpose intended.
The Danish Environmental Health Protection Agency administers the legislation in the area of biocides.
You can read more about biocides at the website of the Danish Environmental Health Protection Agency.
Cosmetics cover products for personal care, e.g. products for enhancing the appearance or odour of hair, skin, teeth, etc. like shampoo, soap, lotion, toothpaste, sun products, hair removers, make-up, dental whitening agents and deodorants.
Cosmetics do not need to be approved before they can be placed on the Danish market, but they must comply with the provisions of the Danish executive order on cosmetics, which is administered by the Danish Environmental Health Protection Agency.
You can read more about cosmetics at the website of the Danish Environmental Health Protection Agency.
Medical devices means equipment used for the diagnosis, treatment or easement of a disease in humans, e.g. syringes, surgical instruments, pacemakers and crutches, etc.
The manufacturer is responsible for ensuring that medical devices fulfil the safety and performance requirements of the law. There is no requirement for manufacturers to obtain a marketing authorisation from the Danish Medicines Agency, which administers the medical devices legislation.
You can read more about medical devices at our website medicaldevices.dk.