A nationwide reporting and monitoring system, known as pharmacovigilance, exists to oversee the continued safety of veterinary medicines under actual use conditions.
Pharmacovigilance data, in particular reports of suspected adverse reactions in treated animals, are collected and scientifically evaluated by the IMB. These reactions are reported either directly to the IMB or indirectly by the company responsible for marketing the product (the marketing authorisation holder). In addition to the monitoring of suspected adverse reactions in treated animals following the use of a product in accordance with label recommendations, the scope of the veterinary pharmacovigilance system also covers other aspects of post marketing surveillance including:
- Suspected adverse reactions associated with extra-label use
- Lack of expected efficacy of a veterinary medicinal product when used in accordance with label recommendation
- Surveillance of environmental impact
- Violations of approved residue limits
- Harmful and unintended effects in humans exposed to veterinary medicinal products
The current legal framework for the pharmacovigilance of veterinary medicinal products is set out in Directive 2001/82/EC as amended of the European Parliament and of the Council. This legislation describes the respective obligations of the marketing authorisation holder and the competent authorities with respect to collecting, collating and evaluating information about the safety of veterinary medicinal products under actual use conditions.
Further information is provided in this section of the website including:
- PSUR Reporting Requirements
- Adverse Reaction Reporting
- Adverse Reactions Annual Reports
- European Pharmacovigilance Guidelines
In addition, the Frequently Asked Questions and Useful Links sections provide further information relating to pharmacovigilance.