Changes in Pharmacovigilance Reports ANMAT Resolution – No. 3031/2024
Healthcare & Life Sciences Department Report | Changes in Pharmacovigilance Reports: ANMAT Resolution – No. 3031/2024
Dear Sir/Madam,
On April 5th of the current year, Disposition No. 3031/2024 (“Resolution”) was published in the Official Gazette by the National Administration of Drugs, Food, and Medical Devices (“ANMAT” by its acronym in Spanish). This Disposition implements the “eReporting Industry” platform as the unique system for submission, by the companies “Holders of Authorization for Registration and Commercialization of Pharmaceutical Products” (“TARC” by its acronym in Spanish), for notifications regarding suspicions of adverse reactions, events supposedly attributable to vaccination and immunization, and/or other safety issues related to the use of pharmaceutical products.
Within the framework of Disposition No. 5358/12, which approved Good Pharmacovigilance Practices, ANMAT previously entered into an agreement with the Uppsala Monitoring Center (“UMC”) of the World Health Organization (“WHO”) for the use of the products “VigiLyze”, “VigiFlow”, and “eReporting” in order to implement, more efficiently, the direct submission of notifications of suspected adverse reactions, through manual input or XML format.
With the aim of unifying the channels for reporting in the Pharmacovigilance and Risk Management Department through an efficient and agile system, ANMAT has entered into an agreement with the UMC that incorporates the “eReporting Industry” tool into the services mentioned in the previous paragraph.
Since 2023, the “eReporting” system has been implemented for patients, professionals, and peripheral providers for the submission of reports of adverse reactions, events supposedly attributable to vaccination and immunization, and/or other safety issues related to the use of pharmaceutical products.
In light of this and this new Disposition, TARC must implement “eReporting Industry” and the MedDRA and WHODrug coding systems, for which they must process the corresponding licenses, having a period of 180 consecutive days from the entry into force of the Dispositionto do so.
Some clarifications on terminology:
– What is “eReporting”? It is a notification system aligned with the international guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regarding the structure of the form compatible with ICH-E2B and the coding of information by adding MedDRA – Medical Dictionary for Regulatory Activities and WHO Drug Dictionary.
– What is MedDRA? It is a standardized and highly specific medical terminology developed by ICH to ensure consistency and prevent data distortion, facilitating the international exchange of regulatory information for pharmaceutical products used by humans.
– What is the WHO Drug Dictionary? It is a global dictionary of drugs and active ingredients intended for human use, whose development and maintenance are the responsibility of the UMC, which includes all drugs marketed in a country, at the request of the country.
Furthermore, TARC must process users through the Pharmacovigilance and Risk Management Department with a minimum notice of 45 consecutive days prior to the start of notification submission via the “eReporting Industry” tool.
The procedure for submitting notifications must be carried out in accordance with the instructions established in the “eReporting Industry User Manual”, which will be published on the institutional website.
Notwithstanding the foregoing, other notification channels for healthcare professionals and peripheral providers remain valid.
This Resolution entered into force on the day of its publication.
Sincerely,
Ana Andrés