By means of Disposition No. 3031/2024 (the “Disposition”), the National Administration of Food, Drugs and Medical Technology (the “ANMAT”) established the implementation of the “eReporting Industry” platform, as the only means by which companies who hold an Authorization for Registry and Commercialization of Medical Specialties (Titulares de Autorización de Registro y Comercialización de Especialidades medicinales or “TARC”) may send to the Pharmacovigilance and Risk Management Department of ANMAT, all the notifications related to suspicions of side-effects, events that can be linked to vaccination and immunization, or all other sort of security problems related to the use of medicines, such as medication errors, lack of effectiveness, and pregnancy exposure. The Disposition also establishes that the TARC shall implement the MedDRA and WHODrug coding systems, for which the corresponding licenses will be needed.
The implementation of the “eReporting Industry” platform must be fulfilled by the TARC within 180 (one hundred and eighty) calendar days from the entry into force of the Disposition, i.e., upon its publication in the Official Gazzette. Additionally, the TARC must request before the Pharmacovigilance and Risk Management Department of ANMAT a username within 45 (forty-five) calendar days before the notifications begin to be sent through the “eReporting Industry” platform.
The Disposition concludes by clarifying that the user’s manual for the new platform will be available on the regulator’s website, while also stating that, notwithstanding that the “eReporting” platform has already been implemented for patients, health professionals and peripheral effectors, the other reporting channels currently in use will continue to be available only to these notifiers.
