- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Herbal products are not classified as medicines unless they have been registered through the marketing authorization process with the Norwegian Medicines Control Authority. A separate guideline, including documentation requirements, has been developed for herbal remedies for which applications are made for marketing authorization as medicines. If these products are not granted a marketing authorization, they can be sold as herbal remedies but no medicinal claims may be made for them .
In January 1994, a guideline for the registration of natural remedies was published, based on the European directives and particularly on article 4.8 (a) (ii) of Directive 65/65/EEC . Reference is made to the Notice to Applicants. These guidelines for a simplified registration procedure describe medicinal products containing substances which are not prescription-only, which are suitable for self-medication, and for which there is documentation on their traditional use in Europe or North America. Eardrops, eyedrops and eye-ointments are excluded, together with injections, prescription-only or toxic substances, and isolated chemically defined substances from medicinal plants. There are detailed provisions laid down in these guidelines which require expert reports and documentation on quality, safety and efficacy .
According to "The Guidelines on Marketing Authorizations for Natural Remedies", a natural remedy is defined as a medicine for self-treatment, in its original package, intended for an individual consumer, and in which the active ingredient or ingredients derive from natural sources such as the vegetable or animal kingdom, or in certain cases micro-organisms, salts and minerals. Plant material may include juices, gums, fatty oils, essential oils, extracts or tinctures. Combinations of herbs with vitamins and/or minerals are not regarded as natural medicines, but these constituents are allowed. With respect to quality requirements, reference is made to the European guideline "Quality of Herbal Remedies" as well as to the Notice to Applicants. Tinctures and extracts shall be as described in an official monograph of the European Pharmacopoeia or another pharmacopoeia. Tinctures and extracts which are not described in a pharmacopoeia should be specified according to the medicinal plant and solvent, including the alcohol concentration. In the case of a combination of extracts, each solvent and drug should be specified. The medicinal plants should be described with their Latin name together with the Norwegian name and the part of the plant used. For the manufacture and control of these products, the rules of Good Manufacturing Practice (GMP) are applicable. Quality control consists of e.g., identification check for impurities, and quantitative assay [48,85].
With respect to safety, the requirements are based on the WHO "Guidelines for the Assessment of Herbal Medicines" of 1991, as are the requirements for efficacy. Several examples are given for the wording of indications relating to minor ailments, e.g., improvement of appetite. The documentation on efficacy may consist of a compilation of the relevant literature. This means a summary of all the bibliographic references to the respective ingredients, their medicinal background and traditional use or, if not available, clinical documentation, for example on randomised controlled clinical studies. There are four categories for the documentation of efficacy:
1. Traditional use that is documented in one of the references of an enclosed list.
2. Natural remedies containing additional vitamins and/or minerals for which maximum doses must be taken into consideration.
3. Natural remedies which are not within the scope of categories 1 or 2 and for which a full toxicological and clinical dossier must be submitted.
4. Combination products which must have a justification and documentation such as laid down for category 1.
In the case of herbal teas, active ingredients should not exceed a maximum of 70% by weight, and other ingredients (e.g., aromatics) should not exceed a maximum of 30% by weight. For dosage forms such as tablets, capsules or tinctures, up to five active ingredients are normally accepted.
The Norwegian guidelines also contain requirements for the content of the label and the package leaflet. Registered natural remedies receive a registration number which will appear on the label. The annex to the guidelines consists of a list of 32 references .