On November 9th , 2023, in use of her faculties, the Director of the National Health Regulation Authority (hereinafter “ANRS” by its abbreviation in Spanish), approved the Regulation for the withdrawal from the market, final disposal of products regulated by the ANRS and management of substandard and falsification products; which would have a transitory period of three (3) months counted from its execution, that is to say that, as from February 9th, 2024, all persons included in the regulation must comply, adjust their processes, request approval and inform the ANRS, of the acts to be carried out in relation to what is set forth therein and which details are described below.
This resolution answer to the objectives of the Sustainable Health Agenda for the Americas 2018-2030 (ASSA 2030 by its abbreviation in Spanish) and the need to create mechanisms to ensure the adequate withdrawal from the market of products regulated by the ANRS, classify unforeseen risks and apply corrective and preventive measures, as well as the application of sanctions.
