Homeopathic medicinal products must be registered at the Medical Products Agency in order to be sold on the Swedish market.
The Swedish Medicines Act [1992:859] was enacted on 1 July 1993. According to this law, homeopathic products must be registered at the Medical Products Agency in order to be sold on the Swedish market.
Registration in Sweden complies with articles 14 and 15 of Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use, as well as articles 17 and 18 of Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.
When evaluating the application for registering a homeopathic product, the Medical Products Agency examines e.g. the quality, safety, labelling and homeopathic use of the product.
The Medical Products Agency does not assess the efficacy of homeopathic products. There are no requirements for using clinical studies or supportive scientific literature to demonstrate an effect of a homeopathic product. Furthermore, no effect and/or indication may be claimed for a homeopathic product.
Basic rules for homeopathic products
A registered homeopathic product has been evaluated for whether:
- the quality and safety of the final product are in compliance with applicable regulations
- manufacturing has been carried out in a qualitatively acceptable manner following GMP (Good Manufacturing Practice)
- the manufacturing has complied with established homeopathic methods
- the raw material has been previously used in homeopathy.
There is a common regulatory framework for all EU member states (Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use). In accordance, homeopathic medicinal products shall:
- only be administered topically or orally
- be safe
- not be accompanied by information about efficacy or therapeutic indication
- not contain more than one part in 10 000 of the mother tincture (equivalent to D4 in the final product).
- whenever an active substance that is found in a prescription drug is used, the homeopathic product must be diluted at least 100-fold compared to the lowest dose for which a prescription is required.