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Pharmacovigilance

Veterinary pharmacovigilance currently covers:
- clinical seaftey of veterinary medicinal products for target spieces,
- area of adverse reactions which happened to human beings in connection with veterinary medicinal products,
- area of insufficient efficacy of VMPs,
- inadequate withdrawal periods,
- potential environmental problems linked to using of VMPs and
- adverse reactions in case of off-lable use of VMPs, including misuse or wrong use of VMPs.

Task of veterinary pharmacovigilance is safety assessment of veterinary medicinal product which are on the market with broad clinical use.

The main objective of ÚSKVBL is to create such system which will monivate all relevant stakeholders and persons to report adverse reactions and based on these information that users of veterinary medicinal products will have at disposal all necessary information on properties of veterinary medicinal products and that risk/benefit ratio is still benefitial.

Individual stakeholders and involved persons have different roles in this system. For this reason the pahrmacovigilance section of ÚSKVBL web page is divided into three parts:
- marketing authorisation holders
- veterinarians and breeders/owners of animals
- other stakeholders

Pharmacovigilance section contains also information on adverse reaction reporting of approved veterinary preparations (non-medicinal) and adverse events of veterinary technical devices (part "Other products").

Last part of this section is dedicated to summary of most significant adverse reactions reported to ÚSKVBL.



Pharmacovigilance