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What are ANMAT´s objectives?

To authorize and register the manufacture and marketing of medicinal, diagnostic and cosmetic products, as well as their updates and modifications. To monitor the premises engaged in the manufacture, import, fractionation and/or marketing of the above mentioned products, in addition to setting the regulations and technical specifications they must comply with. To control the composition, quality, efficacy and harmlessness of the above mentioned products. To authorize, register, control and monitor the quality and healthiness of foodstuff including dietary supplements and any material in contact with foodstuff. All this is carried out as a joint task together with the federal health jurisdictions and INAL offices. To participate in the creation and update of regulations. To authorize, register, control and monitor the quality and healthiness of household cleaning products as well as the material in contact with them. To authorize medical devices as well as the materials and equipment to be used in human medicine. To formulate and enforce regulations assuring the quality of medical devices manufacture, import and storage processes. To watch the undesired effects, inefficacy and quality failure of the products it regulates. To this end, it develops information networks which gather the notifications made by professionals, institutions and users by means of the Pharmacovigilance, Technovigilance and Food Vigilance National Systems. To communicate and disseminate health related significant information among professionals and public in general, through periodical and non-periodical publications. To promote that clinical investigation on new drugs in Argentina be based on the “Good Practices for Clinical Pharmacology Studies”, in compliance with international ethic regulations and with a specific inspection program. To authorize the advertising of over-the-counter drugs, dietary supplements and medical devices with a view to facilitating their consumption and use as well as guiding consumers in doing so.
Avenida de Mayo 869 (C1084AAD) - Ciudad Autónoma de Buenos Aires - Argentina - Tel: 54-11-4340-0800