Contacts

Implements:

  • cconducting a specialized examination of the clinical and pharmacological section of the registration dossier for medicinal products as part of a set of preliminary technical works related to the state registration (confirmation of state registration) of medicinal products, making changes to the registration dossier of previously registered medicinal products;
  • conducting a specialized examination of documents in modules 1, 2, 4 and 5 of the registration dossier of medicinal products for medical use as part of a set of examinations carried out during the registration of medicinal products (confirmation of registration) and other procedures related to the registration of medicinal products for medical use in accordance with the requirements of international treaties and acts constituting the law of the Eurasian Economic Union;
  • technical support for the implementation of the administrative procedure for coordinating the advertising of a medicinal product, a method of providing medical care, work or services constituting medical activity, a medical product, medical equipment, a biologically active food supplement (hereinafter referred to as advertising), reviewing advertising for its compliance with the requirements of advertising legislation;
  • 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;
  • participation in the inspection (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;
  • participation in the inspection (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.

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