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French Agency for Food, Environmental and Occupational Health & Safety

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Veterinary pharmacovigilance

Veterinary medicinal products are only granted Marketing Authorisations (MAs) if the evaluation of their quality, safety and efficacy demonstrates that the benefits of use outweigh the possible risks. Veterinary clinical trials performed for MA applications enable researchers to identify a certain number of adverse events likely to occur following use of the medicinal product. However, these tests are carried out in a limited number of animals, under standard conditions of use. Large-scale use of the medicinal product, once it has been granted an MA, in the context of routine practice then enables more specific detection of adverse events, and identification of potential risk factors such as species, subspecies, age, pre-existing conditions, and so on. The role of pharmacovigilance is to detect any emerging signal as quickly as possible, whether it involves an unknown adverse event or a known effect that has unexpected frequency or severity. This post-MA monitoring is used to adjust risk management measures where necessary. These measures range from addition of a warning for use in the package leaflet to withdrawal of the MA.

 

Monitoring of adverse events of veterinary medicinal products is carried out via a veterinary pharmacovigilance system that has been fully operational since 2002. The effectiveness of the system is based on spontaneous reports, which today are submitted by veterinarians in more than 90% of cases. These notifications are then recorded and assessed by both the MA Holder and institutional actors which include the French Agency for Veterinary Medicinal Products (ANSES-ANMV) and the Veterinary Pharmacovigilance Centre in Lyon (CPVL). Potential signals identified in this way are then evaluated in a collective way. This evaluation may be performed at the European level with experts from Competent Authorities in other EU Member States and nationally with experts from the French Commission for Veterinary Medicinal Products.

The pharmacovigilance system makes it possible to detect adverse events in animals and to better characterise these events. Reporting adverse events allows continual monitoring of the risks and benefits of veterinary medicinal products after they are made commercially available, thus contributing to safe use.

By reporting adverse events, you can help to improve knowledge of veterinary medicinal products which will benefit animals, their owners, and other actors in the field of animal health.

 

Which cases should you report?

  • Adverse events leading to death
  • Adverse events causing pronounced, prolonged or permanent symptoms (new definition of serious cases)
  • Unexpected adverse events (not mentioned on the product package leaflet)
  • Adverse events in humans
  • Adverse events observed during use for a therapeutic indication other than the approved indication (off-label use)
  • Known adverse events (included in the package leaflet) that are severe or that seem to be increasing in frequency and/or severity
  • Lack of efficacy versus expected efficacy (a sign of possible development of resistance)
  • A problem related to withdrawal periods (possibly leading to residue levels above maximum limits)
  • Suspected environmental problem such as pollution

Batch recalls

17/04/2012 – ANSES withdraws the Marketing Authorisation for certain anti-parasitic collars for pets

17/10/2011 – Quality defects and recalls of veterinary medicinal product batches

Following the transfer of management of quality defects and batch recalls for veterinary medicinal products from the Establishments unit to the Inspection unit of the ANMV’s Inspection and Controls department, reports and exchanges of information should be forwarded to:

E-mail: defautsqualiteMV@anses.fr – Fax: +33 (0)2.99.94.66.71.

Recall procedure (pdf) (in French)