Implements:
- conducting a specialized examination of the clinical and pharmacological section of the registration dossier for medicines within the framework of their state registration, confirmation of state registration, and making changes to the registration dossier on the territory of the Republic of Belarus;
- conducting a specialized examination of documents as part of modules 1, 2, 4 and 5 of the registration dossier of medicines for medical use within the framework of their registration (bringing the registration dossier of a medicinal product in accordance with the requirements of the Eurasian Economic Union), confirming registration (re-registration), making changes to the registration dossier in accordance with the requirements of the Eurasian Economic Union;
- implementation of the administrative procedure for approving advertising on:
- medicines;
- the method of providing medical care, work and services that make up medical activity;
- medical devices;
- medical equipment;
- biologically active food additives;
- carrying out a set of preliminary technical works to issue a conclusion within the framework of obtaining permission to conduct clinical trials (trials) of medicines;
- organization of examination of documents submitted for making a significant amendment to the program (protocol) of clinical trial of a medicinal product;
- implementation of measures to ensure proper fulfillment by holders of registration certificates of pharmacovigilance tasks and responsibilities in accordance with the requirements of the Rules of Good Practice of Pharmacovigilance of the Eurasian Economic Union;
- coordination of information letters for medical professionals about changes in the safety/efficacy profile of the drug;
- coordination of drug risk management plans;
- examination of periodic updated reports on the safety of medicines;
- provision of information on adverse reactions detected on the territory of the Republic of Belarus for the preparation of a periodic updated safety report for medicines;
- coordination of educational materials for medical professionals, pharmaceutical workers and patients for medicines;
- conducting inspections (pharmaceutical inspections) of clinical trials (trials) of medicines for compliance with the requirements of the Rules of Good Clinical Practice of the Eurasian Economic Union;
- conducting inspections (pharmaceutical inspections) for compliance of the organization and functioning of the pharmacovigilance system of holders of registration certificates with the requirements of the Rules of Good Practice of Pharmacovigilance of the Eurasian Economic Union.
