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null Pharmacovigilance

Pharmacovigilance

Pharmacovigilance

Pharmacovigilance

The aim of the pharmacovigilance system is to increase the safety of the veterinary medicinal products by gathering and analyzing the adverse reactions occurring during their application, see Definitions, as well as the data about assumed lack of efficacy, reactions for the reason of extra label use, eventual residues detected following the end of the withdrawal period and effects damaging the environment, summing up: the pharmacovigilance data. According to the evaluation of the collected data, in well-founded cases, measures limiting the application of the product or amendment of the package leaflet will be able to be taken.

 

About the details of the pharmacovigilance system see here.

Reports on the observed adverse reactions and other pharmacovigilance data can
be made by filling the Reporting form for veterinarians and other health care professionals.

If the marketing authorization holder becomes aware of a serious unexpected and
a human adverse reaction, it is obliged to inform the Directorate right away or
within 15 days at the latest.

The notification via computer can be made directly by using the Eudravigilance system or after the Directorate's approval, by filling and sending the European Veterinary Pharmacovigilance Reporting Form for MAHs. The Form is to be filled in Hungarian or in English (recommended).

According to the a Decree No. 128/2009.(X.26.) MARD  the marketing authorization holder is obliged to prepare a periodic safety update
report, and send it to the Directorate.

The content specification and the guideline for the filling are found here: Periodic Safety Update Report (PSUR) and Guideline for PSUR.

 
Reporting form for veterinarians and other health care professionals

European Veterinary Pharmacovigilance Reporting Form for MAHs

Guideline for the presentation of the Periodic Safety Update Report

PSUR synchronisation - Pilot phase