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
 

Argentina

Distribution

In Argentina medicinal plants are available through different distribution channels, of which only the pharmacies, herboristerias and the pharmaceutical industry are controlled by pharmacists, in accordance with the law describing the responsibilities of a pharmacist, the Drug Law and the National Pharmacopoeia. Herboristerias are authorized to sell vegetable drugs but not mixtures. They have to employ a pharmaceutical technical director. Mixtures of vegetable drugs are controlled, together with preparations made by industry, under the Drug Law No. 16.463. It is relevant to mention a project of the Provincia de Buenos Aires to oblige the herboristerias to act only as wholesalers. Furthermore, persons who grow medicinal plants should have an authorization by the Ministry of Health [15].

Legal Status

For the marketing authorization of a new medicinal product, it is in general required to have a laboratory and to fulfil the legal requirements of article 27 of the Law No. 16.463. There is no difference between herbal medicines and chemical drugs. When the active principle is described in the Pharmacopea Nacional Argentina, reference can be made to such a monograph. If not, a "Pre-monografia" has to be presented for approval by the Instituto Nacional de Farmacologia y Bromatologia which is responsible for drugs and food. A certification number will be granted which allows sale at a national level. But, at provincial level, each "provincia" has its own system of approval for medicinal drugs, and the certification number is only valid when accepted by a provincia. With respect to the documentation needed to fulfil article 27, the Instituto Nacional de Farmacologia y Bromatologia has issued an information sheet [15].

Lack of controls for raw materials

Prior to 1993, the following were important problems:

- there was no control for the collection in the wild of medicinal plants;

- there were no scientific criteria for the collection of these plants;

- there was no control of the methods of drying, conservation or grinding;

- although herboristerias were controlled by law, the sale of medicinal plants through other distribution channels was completely uncontrolled, which might be of critical importance where potentially toxic plants are sold;

- although pharmacognostic methods are described in the Pharmacopea Nacional Argentina, no methods for the determination of active principles, e.g., quantitative assay, were indicated;

- there was no official definition of what is a medicinal plant and what is not, some plants being used as food although they were included in the pharmacopoeia; and

- with respect to the Law No. 16.463, it was not clear which requirements had to be fulfilled to apply for registration of a new medicine based on medicinal plants.

Although scientific knowledge on medicinal and toxic plants was growing, it was necessary to gain more information about the utilization of 700-800 species. There was no academic specialization for the control and the processing of medicinal plants [15].

For these reasons, the need for future legislation to remedy the unsatisfactory situation relating to medicinal plants became evident [15].

In November 1993, a regulation for registration and commercialization of medicinal plants was published by the Health Ministry of the Provincia de Buenos Aires. With this regulation, an obligation for the registration of medicinal herbs was established. The herboristerias had to register their products within 180 days, together with documentation containing e.g., name of the plant, part of the plant, active principles, identification, and indications. In the case of a mixture of herbs, the benefit of the combination had to be demonstrated. The certificate issued by the Laboratorio Central de Salud is valid for five years, and a prolongation must be applied for 30 days before expiry [16].

The Pharmacopea Nacional Argentina

Within the Pharmacopea Nacional Argentina, there are three categories of plants and their preparations: crude drugs; extracts or fractions with a complex chemical composition extracted directly from a medicinal plant, e.g., fixed or essential oils or resins; and pure active principles. The total number of such monographs is 899. The monographs do not consider pharmaceutical preparations such as extracts, tinctures, aromatic waters etc. Of the 899 monographs, 56 describe crude drugs, and 33 describe extracts or fractions [15].

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