- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
In July 1990, an order was issued by the Ministry of Health setting out detailed legal requirements for natural products and pharmaceutical preparations thereof that have traditionally been used. A natural product is defined as a material of a natural origin that has traditionally been used for therapeutic purposes, and that has only been treated (processed) by physical methods. A pharmaceutical preparation is defined as a product thereof with a pharmaceutical form and a traditional empiric use for therapeutic purposes, used only orally or administered topically. Products with therapeutic indications have to be registered as medicines, herbal teas are registered as food. Detailed requirements are given that the plant material has to fulfil with respect to cultivation, collection, drying, etc. For the manufacturer of pharmaceutical preparations, a special licence is needed. Plant material is allowed to be brought into the market, individually packed and not mixed, with a special authorization, and a therapeutic use must not be indicated. Pharmaceutical preparations need a registration that has to be applied for with a technical dossier containing documentation on the manufacturing process, quality control and, if necessary, toxicity studies, together with monographs on the material, including its traditional use, method of application, dose, contra-indications, adverse reactions, and a bibliography. If already registered in two or more countries (which are specifically listed), reference may be made to such a previous registration with respect to the documentation of efficacy. In the case of a medicinal plant product, it has to be certified that the plant is included in an official plant list. Drafts of a label and a leaflet have to be submitted. The registration is valid for ten years and may be renewed .
In August 1990, a resolution published by the Ministry of Health listed 17 plants, their common and botanical names, the parts used, and their traditional use which has been officially accepted, and to which reference may be made .