Legislative framework
Reporting of occurrence or suspicion of occurrence of adverse reactions is carried out in accordance with Act No 362/2011 on Medicinal Products and Medical Devices, §109 and EC Regulation 726/2004, Articles 47-51.
In the event that an adverse event occurs during/after the administration of a veterinary medicinal product or a medicinal product for human use to animals, veterinarians or animal keepers must report the event as soon as possible after the event.
The following shall be reportable:
- any harmful and unwanted reaction of the animal to the veterinary medicinal product
- any observation of a lack of efficacy of the veterinary medicinal product following its administration to the animal, whether or not in accordance with the summary of product characteristics (SPC)
- any observed environmental accidents following the administration of the veterinary medicinal product to the animal
- any adverse reaction in humans exposed to the veterinary medicinal product
- any detection of a pharmacologically active substance or residue marker in a product of animal origin in excess of the maximum residue levels established in accordance with Regulation (EC) No 470/2009 after the established withdrawal period
- any suspected transmission of an infectious agent via a veterinary medicinal product
- any harmful and unwanted reaction of the animal to the medicinal product for human use
Reporting to the National Medicines Agency
Reporting can be made directly to the National Medicines Agency – Institute of State Control of Veterinary Biopreparations and Medicinal Products (ISVBL) via the forms available at www.uskvbl.sk