Clinical Trials

Clinical trial of a veterinary medicinal product is a study conducted on target species or animal category for the purpose of identifying, determining or confirming clinical, pharmacological, pharmacodynamic effects of one or more investigated medicinal products, as well as studying resorption, distribution, metabolism and elimination of one or more veterinary medicinal products, aiming to deterimine safety, efficacy and therapeutic effect of veterinary medicinal product.

Clinical trials of medicinal products shall be conducted in accordance wth Good Clinical Practice guidelines in Clinical Trials.

Medicinal products shall be clinically tested based on results of pharmaceutical and pharmacological-toxicological testing.

Medicinal products used in clinical trials must be produced in accordance with the Good Manufacturing Practice guidelines and marked with a label: “For Clinical Trials”.

Medicines and Medical Devices Agency of Serbia receives applications from manufacturers for the conduction of phase IIIa, IIIb and IV clinical trials of medicinal products, i.e. medicinal products in the development stage and medicinal products already placed on the market and performs control of clinical trial conduction pursuant to the Law on Medicines and Medical Devices, legislation passed in relation to the implementation of this law, as well as guidelines for Good Clinical Practice in clinical trials. The clinical trial applicant may request that the Agency carry out control of the clinical trial at sites where the clinical trial is conducted. In exercising control over the implementation of a clinical trial, the Agency may suspend or prohibit the clinical trial.