Vigilance
Agency of Medicines and Medical Devices of Serbia, according to the Law on Medicines and Medical Devices (OG 30/10) undertake the survelillance of veterinary medicinal products, processing and the assessment of the adverse reactions in animals and humans.
Activities performed by the Agency in this regard include:
-collection, processing and evaluation of data on adverse drug reactions related to the use of drugs for which MA has been granted, or during clinical trials;
-processing and evaluating periodic reports on drug safety (PSURs), which the Agency receives from the marketing authorization holders
-notification the holder of the marketing authorization of serious adverse reactions to the drug immediately and not later than 15 days from the date of receipt of such information
-inform the competent institution of the EU on the record of serious adverse reactions on the territory of the Republic of Serbia.
-notification the Ministry in charge of veterinary matters as well as veterinarians of serious adverse reactions to the drug and the significant changes in the safety of the medicine immediately, and no later than 15 days from the date of receipt of such information
-encouraging veterinarians to report adverse drug reactions, or suspected adverse reactions
-making a database of information collected in pharmacovigilance system available to the public and the authorities at home and abroad in accordance with the internationally accepted standard terminology (VEDDRA)
-exchange of information collected in pharmacovigilance system with the authorities for pharmacovigilance in other countries.
Mandatory reporting means the reporting of serious adverse reactions to the drug, manifested during clinical trials or in the period after obtaining the marketing authorisation. Mandatory reporting, for the purposes hereof, is done by the producer, the sponsor of the clinical trial, the investigator or the contracting organization that performs certain tasks in the implementation of clinical trials, as well as the MA holder;
Spontaneous reporting of adverse reactions to the drug involves voluntary reporting of adverse effects on the market, which appeared during the treatment of patients. Reporting is performed by veterinary institutions, veterinarians or animal owners (reporters).
All suspected adverse drug reactions are reported on Form for reporting adverse reactions to veterinary medicine.