Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution 284/2024 to review and propose modifications to the sale condition of the medicinal specialties, with minimum 5 years permanence in the national market, without any quality, safety, and efficacy issue, under the prescription sale, to obtain free sale declaration.
ANMAT as a decentralized body with jurisdiction has been authorized to supervise, control, and guarantee all medicinal products comply with the technical requirements of the reference or recommendation organization and are in top condition for use. The nature or possible risks of the improper use of medicines and condition of sales (over-the-counter, prescription, archived prescription, and prescription and decree) are included in the decision of ANMAT to grant the “Free Sale” condition.
The status of “over-the-counter” may be declared to any medications developed for minor ailments without requiring any medicinal professional interventions and, able to be considered safe, due to the formulations, usage, conditions, planned doses, and wide safety margin that does not entail dangers for the patients.
Source: Ministry of Health
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