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 (EMA), 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.

Incident management plan

The incident management plan for medicines for veterinary use defines a strategy for the rapid and efficient handling of incidents involving safety issues relating to veterinary medicines authorised in the EU:

It outlines the procedures and management structures to:

  • evaluate a potential incident; 
  • manage the response; 
  • communicate within the regulatory network and with concerned marketing authorisation holder(s);
  • effect closure of the incident. 

The plan was developed in 2010 to account for the experience gathered since 2004 with the crisis management plan on safety issues and to broaden its scope. It was last revised in 2015.

Annual bulletins

The Agency publishes annual public bulletins to inform veterinarians and the public of the main outcomes of post-marketing surveillance activities for veterinary medicines in a calendar year. The bulletin summarises recommendations to amend safety warnings and highlights ongoing monitoring activities for centrally authorised products. 

The latest bulletin shows a near 25% increase in the electronic reporting of adverse events to EudraVigilance Veterinary (EVVet) in 2017. This enhances regulators’ ability to analyse the data effectively, to identify any emerging issue with a medicine and to initiate regulatory actions:

 Veterinary pharmacovigilance bulletin 2017

The bulletin also includes a summary of the discussions and agreements by the Pharmacovigilance Working Party regarding pharmacovigilance issues concerning nationally authorised veterinary medicines.

For previous bulletins, see:

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