Control of herbal medicinal products and homeopathics

In order that they may be sold, herbal medicinal products must be approved by the Swedish Medical Products Agency.

The products are assessed with regard to quality, effect and safety. The quality requirement, i.e. how the product is manufactured, is essentially the same as for an ordinary medicine. Effect and safety can be demonstrated either by the company referring to scientific literature about well-established/traditional medical use, or showing results of clinical trials and other efficacy and safety studies. In contrast to other medicines, herbal medicinal products can be sold by non-pharmacies. This also applies to certain external medicinal products that are approved for simpler and temporary medical conditions where the documentation is largely based on previous use and experience. During 2005, the new EU directive for traditional herbal medicinal products will start to apply. The Swedish Medical Products Agency registers homeopathic products whose safety and quality can be documented.



Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | | Contact information