Clinical trial – a clinical study of a medicinal product that satisfies at least one of the following conditions:

• the assignment of a specific therapeutic strategy (intervention) to a subject of the clinical trial is determined in advance and does not constitute routine clinical practice (i.e., standard (uniform) medical diagnostic and treatment procedures, technologies, or measures performed for a given group of patients or for a given standard of medical care) in the member state whose research centers participate in the clinical trial;
• the decision to prescribe the investigational medicinal product is made together with the decision to include the subject in the clinical trial; in addition to routine clinical practice procedures, additional diagnostic or monitoring procedures are performed with respect to the subjects of the clinical trial.*

*Decision No. 87 of the Council of the Eurasian Economic Commission dated November 3, 2016 “On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union” (as amended by Decision No. 81 of the Council of the Eurasian Economic Commission dated May 19, 2022). Effective date — December 6, 2022.