Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Afficher le documentFOREWORD
Ouvrir ce répertoire et afficher son contenuI. INTRODUCTION
Fermer ce répertoireII. REGULATORY SITUATION
Ouvrir ce répertoire et afficher son contenuAfrica
Fermer ce répertoireThe Americas
Afficher le documentAntigua and Barbuda
Afficher le documentArgentina
Afficher le documentCanada
Afficher le documentChile
Afficher le documentColombia
Afficher le documentMexico
Afficher le documentNicaragua
Afficher le documentUnited States of America
Ouvrir ce répertoire et afficher son contenuEastern Mediterranean
Ouvrir ce répertoire et afficher son contenuEurope
Ouvrir ce répertoire et afficher son contenuSouth East Asia
Ouvrir ce répertoire et afficher son contenuWestern Pacific
Afficher le documentIII. CONCLUSION
Afficher le 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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