Certificate holders registered in the Medicinal Preparations Register for marketed products must notify ANMAT of any circumstances or events known to them that could pose a risk to the supply of products and lead to the temporary or definitive interruption of the supply on the market. The notification must be made within 180 calendar days, and if this is not possible, it must be made within the five days following the recognition of the relevant circumstances that could lead to the interruption of the supply of products authorized by ANMAT.