Denmark

Policy

In Denmark, a wide choice of alternative treatment exists such as zone therapy, osteopathy, homoeopathy, acupuncture, herbal medicine, and so on. Chiropractice is no longer considered an alternative treatment. The provision of complementary and alternative medicine is regulated by a medical law regarding quackery, but it can be practised freely as long as the law is respected. The law states that authorization is required, and that if the individual without professional qualification calls him/herself a doctor or performs surgery, then a penalty will be executed. Acupuncture is considered a surgical operation and, therefore, can only be conducted by an authorized doctor. Alternative medical products are also governed by regulations. As a response to EU directives regarding the production and sale of homoeopathic medicine, these regulations have been revised in Denmark. All alternative medicines sold in Denmark have to be approved by the Danish Medicines Agency, which sets out regulations on production standards, safety and product efficacy. Complementary and alternative medicine is partly accepted by the mainstream medical profession. The Knowledge and Research Centre for Alternative Medicine (ViFAB) was established in 2000. In the future, it is expected that the Centre will continue to explore complementary and alternative therapies and herbal medicines, to raise knowledge of such therapies and their effects and to engage in dialogue with health care providers, complementary and alternative therapists and health care consumers. In 2004, legislation was introduced on a voluntary self-administrated registration arrangement for alternative therapists. Denmark has implemented the reformed EU Common Agriculture Policy, which focuses on the establishment of a common organisation of agricultural markets across member countries, which also covers the sector of medicinal plants and herbs. A major new reform of the CAP is currently being prepared for the period after 2013.

Contact

Ministry of Health, Denmark
Website: http://www.im.dk/English.aspx
Danish Medicine Agency   
Address:  Danish Medicines Agency
Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark
Tel:  +45 4488 9595
Fax:  -
Website: http://laegemiddelstyrelsen.dk/en
The Danish Veterinary and Food Administration
Head Office
Mørkhøj Bygade 19
DK–2860 Søborg
Tel. : +45 33 95 60 00
Fax : +45 33 95 60 01

The Knowledge and Research Centre for Alternative Medicine (ViFAB)

 
Jens Baggesens Vej 90 K, 2. sal - 8200 Århus N. 
Tel: 87 39 15 30
Fax:  -
Website: http://www.vifab.dk/uk/

 

Laws & Regulations

Products that are under the Food Supplement Category require notification or registration with the Veterinary and Food Administration.  The exceptions to this law are those botanical products regarded as safe and sold without claims.  Disease claims are prohibited on all nutritional products.

Herbs - The Danish Food Authorities maintain a list of botanicals that may be used in a single form in foods under specific conditions without prior authorization.  These botanicals may carry no claims and may not have laxative effects.

Herbal products that carry claims or are considered to have high levels of activity must be evaluated and approved by the Danish Medical Agency who will classify them as either natural remedies or medicines.  The European pharmacopoeia is considered legally binding.

Addition of any ingredient for the purpose of enhancement or fortification is regulated by the Danish Food Administration.  Applicants must provide data on safety, efficacy and quality.  The Danish Food Administration uses the 1997 NETTOX list of food plants as a guideline when evaluating the addition of specific botanicals to foods.

A post-marketing surveillance system monitors adverse events.

Contact

Ministry of Health                 
http://www.im.dk/Index/mainstart.asp?o=2&n=3&s=5
The Danish Veterinary and Food Administration
Head Office
Mørkhøj Bygade 19
DK–2860 Søborg
Tel. +45 33 95 60 00
Fax +45 33 95 60 01
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Standards & Guidelines

The Danish Medicines Agency carries out GMP inspection in Denmark. Ordinary medical products requirements also apply to herbal medicinal product. This also includes Herbal Medicinal Products, strong vitamins and mineral preparations, traditional botanical medicinal products and homeopathic medicinal products.

ViFAB (Knowledge and Research Center for Alternative Medicine) is a private institution under the Danish Ministry of the Interior and Health. The institution is responsible for collecting, processing, developing and disseminating knowledge of alternative therapies and herbal medicine. ViFAB is also involved in initiating research on the field of alternative therapy and herbal medicine.

The RAB (Registered Alternative Practitioner) registration system is a Danish registration arrangement managed by the professional alternative organization in Denmark. The objective of the registration system is to consolidate the security of users of alternative therapies. Danish National Board of Health is an organization to approve the application from trade associations for alternative practitioners to become an association responsible for registration. Once the association is approved and appointed, its members can apply for permission to use the protected title of “Registered Alternative Practitioner” (RAB).

Denmark is also one of EU and OECD member countries, and follows the simplified regulatory approval process on Traditional herbal medicinal products under the EU Directive on Traditional Herbal Medicinal Products (THMPD) formally known as The Directive 2004/24/EC.

Contact

Danish Medicine Agency   
Address: Danish Medicines Agency
Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark
Tel: +45 4488 9595
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: http://laegemiddelstyrelsen.dk/en
Danish Medicine Agency   
Address: Danish Medicines Agency
Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark
Tel: +45 4488 9595
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: http://www.vifab.dk/uk/