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Main  //  About  //   Center activity

On October 15, 1997 Ministry of Health of the Republic of Belarus arrived at decision to establish Center for Examinations and Tests in Health Service State Enterprise (order No. 250).

The objective of the Enterprise is to execute activities on provision of safety, efficiency and quality of medicinal products, pharmaceutical substances, medical devices and medical equipment in accordance with the procedure established by the legislation of the Republic of Belarus by conducting a range of works to prepare and carry out expert examination of documentation (including technical inspection of manufacture of medicinal products, medical devices and medical equipment), certification of medical devices and medical equipment, quality control of medicinal products, medical devices and medical equipment.

Center for Examinations and Tests in Health Service Republican Unitary Enterprise implements:

  • a range of works to prepare and carry out expert examination of documentation for:
    • state registration (reregistration) of medicinal products, pharmaceutical substances, medical devices and medical equipment;
    • issuing permits for import of registered and unregistered medicinal products and/or pharmaceutical substances with restricted movement across the customs border of the Republic of Belarus for state registration (reregistration), making amendments to the registration dossier for conducting pre-clinical studies and clinical trials and for usage as exhibition samples;
    • issuing permits for import and (or) export of narcotic drugs, psychotropic substances and their precursors with restricted movement across the customs border of the Republic of Belarus on non-economic grounds;
    • coordination of advertisement of medicinal products, methods, tools, operations and services in the area of prophylaxis, diagnostics, medical treatment (including alternative), rehabilitation and prosthetics, medical equipment and medical devices, medical technologies, biologically active dietary supplements and also of advertisement of goods containing information on their positive effect during disease or decay;
  • services of arranging expert examination of documentation for clinical (bioequivalence) trials of medicinal products, clinical trials of medical devices and medical equipment;
  • reception, registration, and assessment of diagnosed adverse reactions to medicinal products;
  • a range of works on certification of medical equipment and medical devices;
  • quality control of medicinal products;
  • other activities in accordance with the legislation of the Republic of Belarus.