Article 13. Pharmacological control

Pharmacological control is an activity aimed at detecting, assessing, and preventing adverse reactions — unintended and undesirable effects on the body — that are observed in humans when a medicine is used in accordance with its instructions for use.

Treatment-and-prophylactic institutions, pharmacies, and organizations that manufacture, sell, and use medicines must notify the Ministry of Health of the Republic of Uzbekistan in writing of all cases in which adverse reactions are detected during the use of medicines.

The Ministry of Health of the Republic of Uzbekistan shall evaluate adverse reactions identified during the use of medicines; in the course of evaluation, it shall determine causal links between the clinical manifestations of the adverse reaction and the use of the medicine, as well as the ratio of the expected benefit to the potential risk of using medicines.

If facts are identified that affect the ratio of the expected benefit to the potential risk of using medicines, manufacturers and their representatives must take measures to eliminate adverse consequences, to prevent harm to human life or health, and to protect against the use of such medicines.

If evidence is found of non-compliance of a medicine, when used, with the established requirements for safety and efficacy, the Ministry of Health of the Republic of Uzbekistan shall consider the issue of withdrawing such medicine from circulation or suspending its use.