Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
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


In August 1992, the Unidad de Medicina Tradicional was established with the objective to incorporate traditional medicine with proven efficacy into health programmes, and to contribute to the establishment of their practice. A regulation for the control of the practice of alternative medicines was developed, and a legal basis was created (la Ley no. 19.253 of October 1993) which takes into consideration the role of traditional medicine in public health [20].

Legal Status

Natural products are legally differentiated as follows (Código Sanitario):

- drugs intended to cure, alleviate, or prevent diseases (article 97);
- food products for medicinal use and with therapeutic properties (article 98); and
- food products for nutritional purposes (article 108).

According to a regulation for the control of drugs, food products for medicinal use, and cosmetics (decreto no. 435/81), herbal products with therapeutic indication claims and/or dosage recommendations are considered to be drugs. Their distribution is restricted to pharmacies and drugstores which need a special authorization from the Ministry of Health. A registration for marketing authorization is needed for herbal products, homoeopathic products, and other natural products as defined in article 24 of the regulation. An application for registration consists of the complete formula, the labelling, samples of the product, and a monograph which permits identification of the formula and characteristics of the product [20].

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