Herbal medicinal products are medicinal products where the active ingredient consists exclusively of herbal substances or herbal preparations. Natural remedies are medicinal products where the active ingredient is of natural origin and consists of an animal part, a bacterial culture, a mineral or a salt.
Below details specific for these product categories are described. For general information on medicinal products, see the corresponding web pages in the left pane menu.
Herbal Medicinal Products
Herbal medicinal products are medicinal products where the active ingredient consists exclusively of herbal substances or herbal preparations. Herbal medicinal products are covered by Directive 2001/83/EC on the Community code relating to medicinal products for human use ("Directive on human medicinal products") and Directive 2001/82/EC on the Community code relating to veterinary medicinal products ("Directive on veterinary medicinal products)."
The term herbal substance denotes whole or parts of plants, algae, fungi and lichens. The material is usually dried but sometimes fresh, and is defined by specifying the species' full scientific name and the plant part used. Herbal preparations, such as powders, extracts, distillates and press juices, are products obtained by processing herbal substances. The complete definitions can be found in the MPA’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use, or in Directive 2001/83/EC.
Approval or registration?
Herbal medicinal products for human use can obtain a marketing authorisation in one of the following three ways:
- Marketing authorisation in accordance with the documentation requirements in Chapter 3 of the MPA’s provisions (LVFS 2006:11) on marketing authorisation for medicinal products, (Article 8 of Directive 2001/83/EC), a so-called "Full application" in which the efficacy and safety are shown by data from product-specific clinical and preclinical trials in the same way as for conventional drugs.
- Marketing authorisation in accordance with the documentation requirements in Chapter 5,Section 6 and 7 of the MPA’s provisions LVFS 2006:11 (Article 10a of Directive 2001/83/EC), where data from clinical and preclinical trials can be replaced by information on "well established medicinal use" within the EEA for at least ten years, which is supported by scientific literature.
- Registering as a traditional herbal medicinal product in accordance with the documentation requirements in the MPA’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use (Article 16c of Directive 2001/83/EC), in which the efficacy and safety are supported by evidence that the product has been in "traditional use" for at least 30 years of which at least 15 years in the EEA. Safety can be displayed with published scientific literature or product-specific data. Traditional herbal medicinal products are intended only for human use and strictly limited to self-medication that does not require a physician’s diagnosis, prescription or supervision of treatment. However, for some indications it may be required that other serious underlying conditions have been ruled out. The products may only be intended for oral administration, external application and/or inhalation.
Authorised herbal medicinal products can be sold as prescription only products or over the counter products (OTC). The authorised herbal medicinal products that are OTC can be sold in places other than pharmacies if they are included in a list, decided by the MPA, of OTC products that are allowed to be sold in other places than pharmacies (the list is available at the Swedish website). Traditional herbal medicines, however, are always OTC and can be marketed freely in other places than pharmacies.
Natural remedies should meet the basic requirements in the Medicinal Products Act (2015:315).
Natural remedies are medicinal products in which the active ingredient is derived from natural sources, have not been processed too highly and consists of an animal part, bacterial culture, mineral or salt. This means that, for example, isolated compounds or chemically modified ingredients cannot be included in natural remedies.
Natural remedies may only be products which are suitable for self-medication in accordance with tested national tradition or tradition in countries close to Sweden with respect to drug usage.
Natural remedies must have received a marketing authorisation by the MPA to be sold. Approved natural remedies can be sold freely in retail.
Regulatory / Scientific Advice
The MPA provides regulatory / scientific advice on questions regarding the application process. For more information see links in the right pane menu.