Pharmacovigilance

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Veterinary pharmacovigilance concerns monitoring, evaluating and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines. It also involves collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems.

The veterinary pharmacovigilance system in the European Union (EU) operates with the management and involvement of national competent authorities, the European Commission and the European Medicines Agency, in collaboration with the marketing-authorisation holders for the medicines.

The Agency has a coordinating role within the EU veterinary pharmacovigilance system and provides advice to ensure the safe and effective use of veterinary medicinal products.

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