Pharmacovigilance

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 2019 veterinary pharmacovigilance bulletin provides an overview of the new warnings and recommendations agreed for Centrally authorised veterinary medicinal products during 2019. It is also highlighting the ongoing monitoring of potential specific events. The bulletin’s aim is to inform veterinarians and the general public of current pharmacovigilance issues. It also contains an overview of other main pharmacovigilance events during 2019, which were discussed by the Pharmacovigilance working party.

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:

Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products

In addition to the annual pharmacovigilance bulletin, the pharmacovigilance regulatory recommendations include the changes agreed by CVMP during the year following the assessment of pharmacovigilance data for centrally authorised products

The document is updated monthly and is part of an ongoing effort of the Agency to accelerate and facilitate the communication to the stakeholders of regulatory actions related to the safe and efficacious use of centrally authorised products.

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