Pharmacovigilance

Considering outsourcing your pharmacovigilance activities in Latin America? Get in touch with our friends PhV Latam!

In Argentina, the National System of Pharmacovigilance was created in 1993 by the Ministry of Health and Social Action, through the Resolution 706/1993. Its functions are collecting, assessing and organizing the information on adverse reactions to drugs after authorization and commercialization. For the functioning of this entity, a Central Enforcer was established in ANMAT headquarters, and Peripheral Enforcers, institutions with relevant experience such as hospitals or university departments, were added later.  

Who can notify adverse reactions to the National System of Pharmacovigilance?

  • Peripheral Enforcers: mentioned above, these are private and public institutions, of recognized academic or clinic experience. Some of them are the provincial health ministries, professional societies, public and private hospitals, universities and social security organizations .
  • Independent professionals: doctors, pharmacists, nurses, dentists, etc. belonging to hospitals, clinics, practices, private pharmacists, etc. that detect adverse reactions to drugs and communicate their findings directly to the Department of Pharmacovigilance, contributing to the enrichment of the national database.
  • Patients and their relatives: users of drugs that send independent notifications to the Department of Pharmacovigilance.
  • Pharmaceutical industry. the Dispositions 3870/1999 and 2438/2000 integrate the pharmaceutical industry to the National System of Pharmacovigilance.

Once received, notifications are assessed by the professionals working at the Department of Pharmacovigilance of ANMAT. Initially, the quality of the data is evaluated, and then the event is classified according to causal probability and severeness. After, the drug and the adverse reaction are classified according to the WHO-UMS coding system. All this information is input in the database of the Department, and then analysed to take the neccesary control actions.

ANMAT Disposition 3870/1999 requires pharmaceutical companies to designate an employee (professional) as the contact person for all communications with the Department of Pharmacovigilance.

ANMAT Disposition 2438/2000 presents guidelines for the pharmaceutical industry regarding pharmacovigilance activities. Severe or unexpected adverse reactions ocurring in Argentina must be notified within 10 days. All expected and not severe adverse reactions from all over the world must be communicated periodically.

In September 2012, ANMAT issued a new Disposition 5358/2012, containing guidelines for Good Pharmacovigilance Practices, in order to level the quality of the pharmacovigilance activities in Argentina to internationally accepted standards and to increase the participation of the pharmaceutical industry in the efforts for an integrated and efficient national pharmacovigilance system.

NEW! JULY 2013

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products.  The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online form hereHealthcare professionals, the regulated sector (pharmaceutical companies, etc.) and patients can use this new system to notify adverse reactions.

This tool has been developed considering ICH standards. (E2B-ICH guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports) Its purpose is to minimize mistakes, make the data submission more complete and efficient, improve the quality, precision and consistency of reports and establish a common methodology for the presentation of clinical information.

Reports can still be submitted using the previous methodology of downloading the form from the ANMAT website and sending it to the Department of Pharmacovigilance via email, (snfvg@anmat.gov.ar)  fax (0054-11-4340-0866) or regular mail (Av. de Mayo 869, piso 11º -CP AAD1084- Buenos Aires, Argentina) once completed.

The new online reporting system is not yet available for notifications of ESAVI (Adverse Reactions Supposedly Caused by Vaccination and Immunization).

Last update: October 2013

Considering outsourcing your pharmacovigilance activities in Latin America? Get in touch with our friends PhV Latam!

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One Response to Pharmacovigilance

  1. Pedro says:

    ANMAT launched last year a new provision (5358/2012) for PhV. Link: http://www.anmat.gov.ar/boletin_anmat/BO/Disposicion_5358-2012.pdf

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