REPORTING OF ADVERSE EFFECTS
Reporting on adverse effects to medicinal products is important as it facilitates continuous assessment of the risk-benefit ratio involved in the use of the medicinal product and consequently improves its safety. Some adverse effects to the medicinal product may occur after it is used on a larger scale or for a longer period of time compared to the duration in clinical testing. Spontaneous reports sent by veterinarians or animal owners are one of the ways of monitoring the medicinal product during its entire period of use. It is important to report adverse effects even if connection to the medicinal product is only alleged.
The following adverse effects should be reported in particular:
- immediate reporting for adverse effects which end with animal death,
- all adverse effects to medicinal products for animals or suspicion of such effects,
- adverse harmful effects on humans in connection with the use of animal medicinal products,
- absence of expected efficacy of the medicinal product,
- adverse effects which are noticed in exceptional use of medicinal products,
- adverse effects in the use of pre-mixes in the preparation of medicated feed,
- exceeded thresholds of medicinal product residues in food, and
- effects on the environment due to the use of the medicinal product.
A veterinary or any other pharmacovigilance participant who finds any adverse effects of animals to medicinal products in their work or suspect them should communicate this information in accordance with the regulations of the marketing authorisation holder. In addition to the marketing authorisation holder, they must also inform the competent authority for medicinal products (JAZMP) regarding unexpected serious adverse effects (adverse effects resulting in death, direct life threat or cause of permanent or long-term symptoms) which occur in animals or humans after use of the medicinal products in question.