Natural Remedies
A natural remedy denotes a medicinal product in which the active ingredient or ingredients derive from natural sources, have not been processed too highly and consist of part of an animal, bacterial culture, mineral, salt or salt solution. 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.
Herbal Medicinal Products (HMP)
The concept herbal medicinal product was introduced in the Swedish Medicinal Products legislation already in October 2003 (LVFS 2003:7). An herbal medicinal product can be authorised, like any other medicinal product.
Traditional Herbal Medicinal Products (THMP)
In the revised Directive for Medicinal Products special provisions for traditional herbal medicinal products have been added. A simplified registration procedure is introduced for traditional herbal medicinal products (2004/24/EC, article 16a - article 16h) (not an approval, which is the case for regular medicinal products). The requirements on the chemical-pharmaceutical documentation are equal to that of conventional medicinal products, i.e. full documentation is required. The therapeutical indications are strictly limited to self-medication that does not require a physician’s diagnosis, prescription or supervision of treatment. The products may only be intended for peroral intake, external application and/or inhalation. To fulfil the requirements regarding safety and efficacy the applicant must be able to verify that the product in question or a corresponding product has been used for medicinal purposes for a period of at least 30 years at the time of the application, including at least 15 years of use within the European Union.
Committee for Herbal Medicinal Products
The Directive also states that a committee for herbal medicinal products is installed at the EMEA. The provisions in the Medicinal Products ordinance that concern the committee for human medicinal products shall apply by analogy to the Herbal Medicinal Products Committee, HMPC. The most important mission defined for the HMPC is to compile a Community Register of herbal substances and preparations that may be part of traditional herbal medicinal products. The register will list data concerning indication, strength, dosage and route of administration for every herbal substance/preparation. Furthermore, the Committee will produce Community monographs both for traditional herbal medicinal products and for herbal medicinal products with well established medicinal use.
MRP and DCP for Herbal Medicinal Products
The Mutual Recognition Procedure and the Decentralised Procedure will be applicable for any herbal medicinal product that is included either in the register or in a monograph. Cases of arbitration will be decided in the Committee for Herbal Medicinal Products.
Directives concerning Herbal Medicinal Products
The Directives concerning Herbal Medicinal Products are:
- Directive 2001/83/EC of the European Parliament and of the Council relating to medicinal products for human use.
- Commission Directive 2003/63/EC (PDF) amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. This Directive contains the definition of Herbal Medicinal Products.
- Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- Directive 2004/27/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Queries on classification
If uncertainty exists whether a product can be classified as a medicinal product or not, a query can be sent to the Medical Products Agency. This service is presently provided free of charge.
The query must include:
- A list of content where the ingredients are noted both by quality and quantity
- A description of how the product will be marketed, including its intended usage Directions for dosage, if applicable
- The name of the product
Preferably a copy of the packaging, product information leaflet (if applicable) and all marketing material should be enclosed.