Herbal medicinal products and natural medicinal products

Herbal medicinal products or natural medicinal products?

Herbal medicinal products and traditional herbal medicinal products are medicinal products where the active ingredient is of herbal origin. Natural medicinal products are medicinal products in which the active ingredient consists of an animal part (e.g. fish oil), bacterial culture, mineral or salt.

Herbal medicinal products

Herbal medicinal products and traditional herbal medicinal products are medicinal products where the active ingredient consists exclusively of herbal substances or herbal preparations.

Herbal medicinal products may be sold only after their approval by the Swedish Medical Products Agency (Swedish MPA).

Herbal medicinal products for human use, which do not qualify to be approved as medicinal products (in terms of efficacy and safety documentation), and which do not qualify as homeopathic medicinal products, can be registered as traditional herbal medicinal products. Traditional herbal medicinal products may be sold only after they have been registered by the Swedish MPA.

Herbal substance and herbal preparation

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 obtained by processing herbal substances.

The complete definitions can be found in the Swedish MPA’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use.

Marketing authorisation

Herbal medicinal products for human use can obtain a marketing authorisation in one of the following three ways:

1. 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.

2. Marketing authorisation in accordance with the documentation requirements in Chapter 5, Section 6 and 7 of the Swedish 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.

3. Registering as a traditional herbal medicinal product in accordance with the documentation requirements in the Swedish 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 use and/or inhalation.

Selling herbal medicinal products

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 on the list of OTC products that are allowed to be sold in other places than pharmacies. The list is decided by the Swedish MPA and available here at the Swedish website.

Traditional herbal medicinal products, however, are always OTC and may, in addition to pharmacies, be sold in other retail outlets, no special license required.

Natural medicinal products

Natural medicinal products are medicinal products in which the active ingredient is derived from natural sources, has 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 medicinal products.

Limitations

Natural medicinal products shall be suitable for self-medication and may only be used for temporary and mild conditions. The indication (authorised medical use) shall be in accordance with national tradition or tradition in countries close to Sweden with respect to usage of medicinal products.

Selling natural medicinal products

Natural medicinal products must have received a marketing authorisation by the Swedish MPA to be sold. Approved natural medicinal products can be sold in retail, no special license required.

Regulatory/‌Scientific Advice

The Swedish MPA provides regulatory/‌scientific advice on questions regarding the application process.

Legal framework

Herbal medicinal products

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 Regulation (EU) 2019/6 on veterinary medicinal products.

The Directive is transposed into Medicinal Products Act (2015:315) by the Swedish Government and into provisions by the Swedish Medical Products Agency including provisions (LVFS 2006:3) on traditional herbal medicinal products for human use, while the Regulation is applicable without transposition.

Provisions (LVFS 2006:3) on traditional herbal medicinal products for human use (Swedish):

Natural medicinal products

Natural medicinal products should meet the basic requirements in the Medicinal Products Act (2015:315). Further requirements are detailed in the (LVFS 2006:11) on marketing authorisation for medicinal products and the Swedish MPA has published a guideline (only in Swedish) to these provisions with a focus on natural medicinal products. Several provisions in the pharmaceutical field also apply for natural medicinal products.

Links

Lists of approved herbal medicinal products, registered traditional medicinal products and approved natural medicinal products (Swedish).