Pharmacovigilance is the science and activity associated with the detection, evaluation, understanding, and prevention of side effects and other drug safety issues. The main purpose of pharmacovigilance is to prevent harm from adverse reactions in humans that result from the use of medical devices within or outside the conditions of the registration permit and in connection with the life cycle of these products for health care.

The main purpose of pharmacovigilance is to promote the safe and effective use of healthcare products, in particular by providing timely information on the safety of medical devices to patients, healthcare professionals and the public. Thus, pharmacovigilance is an activity that helps protect patients and maintain public health.

Any unintentional and harmful reaction to the drug, if it is caused or accelerated by the active ingredient (one of the other components) or is associated with disorders that occur during production.

Pharmacovigilance activities are carried out in accordance with the "Procedure for pharmacovigilance", approved by the order of the Ministry of Health of Ukraine of 27.12.2006 №898 as amended by the order of the Ministry of Health of Ukraine of 26.09.2016 №996, the standard "Guidelines. Therapeutic drugs. Good Pharmacovigilance Practices ”, approved by the order of the Ministry of Health of Ukraine on 21.05.2015 № 299. These documents are harmonized with international approaches to pharmacovigilance (WHO) and European legislation (Directive of the European Parliament and the Council of 06.18.2002).