Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Open this folder and view contentsAfrica
Close this folderThe Americas
View the documentAntigua and Barbuda
View the documentArgentina
View the documentCanada
View the documentChile
View the documentColombia
View the documentMexico
View the documentNicaragua
View the documentUnited States of America
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth East Asia
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the documentIV. REFERENCES
 

Colombia

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 [21].

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 [22].

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