Provision No. 754/2025 of the National Administration of Medicines, Food and Medical Technology (ANMAT), published on January 30, 2025, sets forth the obligation for the Holders of registered certificates (the ‘Holders’) in the Register of Medicinal Products (REM) that are marketed to notify ANMAT of the circumstances or facts that could jeopardise the availability of the products and cause their temporary or permanent discontinuation in the commercialisation chain. The Holders must inform ANMAT about such circumstances by submitting a sworn statement (DDJJ) via TAD where all the information related to the discontinuation in the commercialization chain (discontinuation data and data on the medicinal speciality) shall be detailed.
The Directorate of Technical Information Management (the ‘Directorate’) will be in charge of keeping the information provided by the holders updated in the National Vademecum of Medicines (VNM).
By means of the aforementioned provision, the holders are granted a term of 30 (thirty) running days, as from the entry into force of this provision (30/01/2025), to update the information regarding the availability of medicinal products, as well as the information on the availability of the medicinal products.
Temporary Discontinuation
The Holder must inform the estimated date of reinstatement in the marketing chain. This date will be published in the VNM. Temporary discontinuation can have a maximum duration of 45 (forty-five) days. Once its commercialisation has been re-established, it must report this circumstance by sworn statement through the TAD procedure.
Permanent Discontinuation
When the Holder decides to permanently discontinue a medicinal product and there is no similar medicinal product marketed in the country, they shall inform this decision at least 6 (six) months prior to the effective discontinuation of the manufacturing and/or importation.
In case of non-compliance with the obligations set forth in the aforementioned provision, the sanctions foreseen in Law N°16.463 and Decree N°341/92 shall be applicable.
Finally, ANMAT Provision N°2038/2017 and ANMAT Circular N°000002/2018 are hereby repealed.
