Pharmacovigilance

Veterinary pharmacovigilance is a monitoring system for ensuring the safety of medicinal products for veterinary purposes, including vaccines with marketing authorisation, used for preventing, diagnosing or treating animal illnesses. The task of veterinary pharmacovigilance is to ensure:

  • safe use of medicinal products in animals
  • animal origin food safety
  • safety of people who come in contact with medicinal products
  • environmental safety

Reporting on alleged or suspected adverse effects directly contributes to the safety of medicinal products.
Based on received reports, JAZMP assesses the ratio between the benefit and the risk of using individual medicinal products. That is why it is important to report all adverse reaction, even if connection to the medicinal product is only alleged.
Activities in the field of veterinary pharmacovigilance include:

  • collecting and evaluation of information regarding adverse effects, and reporting;
  • evaluation of periodic safety update reports (PSUR);
  • evaluation of other information related to medicinal product safety;
  • informing the expert public and the competent veterinary authority about important pharmacovigilance information;
  • encouragement of veterinarians to report adverse effects to medicinal products;
  • participation in the international pharmacovigilance system;
  •  performing pharmacovigilance inspections at the marketing authorisation holders.

The field of veterinary pharmacovigilance is regulated by:

Medicinal Products Act (Official Gazette of the RS [Uradni list RS], No. 17/2014) and Rules on pharmacovigilance of medicinal products for veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 53/2006)

Detailed instructions, Guidelines on Pharmacovigilance for Medicinal Products for Human and Veterinary Use, which are published in Volume 9 of The Rules Governing Medicinal Products in the European Union
JAZMP cooperates in PSUR worksharing procedures.

Veterinary pharmacovigilance in the European Union (leaflet).

Forms are available here.
Please follow the rules regarding the fees in the procedure.