Contacts

The enterprise performs the following types of work.

1. A set of preliminary technical works that precedes state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus, related to:

  • primary expert examination of documents required for state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus;
  • inspection of production of medical devices and medical equipment;
  • expert examination of the results of sanitary and hygienic tests of medical devices and medical equipment of domestic and foreign manufacture;
  • expert examination of the results of technical tests of medical devices and medical equipment of domestic manufacture;
  • specialised expert examination of documents required for state registration (re-registration) of medical devices and medical equipment, introduction of amendments to the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus;
  • expert examination and approval of clinical testing programs for medical devices and medical equipment designated by the Ministry of Health, expert examination of test results;
  • clinical evaluation based on clinical data and evidence of equivalence of medical equipment previously registered in the Republic of Belarus (for large-sized equipment requiring supply of communications, construction and (or) installation works);
  • other studies.

2. A set of preliminary technical works that precedes state registration (confirmation of state registration) of biomedical cell products, introduction of amendments to the registration dossier of biomedical cell products previously registered in the Republic of Belarus.

3. Issuance of duplicate copies of marketing authorisations for medical devices and medical equipment.

4. A set of preliminary technical works that precedes state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus, related to:

  • primary examination of documents required for state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus;
  • inspection of industrial production of a medicinal product for compliance with the requirements of Good Manufacturing Practice;
  • testing of medicinal products quality control procedures as well as analysis of medicinal product quality when conducting clinical trials by state health care organisations;
  • specialised examination of documents, including test reports on studying bioavailability (bioequivalence) of a generic drug assigned by the Ministry of Health, clinical trials reports of a medicinal product assigned by the Ministry above, and other studies necessary for state registration (confirmation of state registration) of medicinal products, introduction of amendments to the registration dossier for a medicinal product previously registered in the Republic of Belarus.

5. Carrying out registration and expert examination of medicinal products for human use in order to register and form a common market for medicinal products within the framework of the Eurasian Economic Union as well as other procedures related to the registration of medicinal products for human use within the framework of the Eurasian Economic Union.

6. Carrying out expert examination of safety, effectiveness and quality of medical devices in order to register and form a common market for medical devices within the framework of the Eurasian Economic Union as well as other procedures related to registration of medical devices within the framework of the Eurasian Economic Union.

7. Acceptance and verification of documents for registration of maximum selling prices of manufacturers for medicinal products, preparation and issuance to applicants of an extract from the Order of the Ministry of health of the Republic of Belarus on the decision taken regarding registration of maximum selling prices of the manufacturer for medicinal products, maintaining the State Register of Maximum Selling Prices of the Republic of Belarus and its updating.

8. Carrying out works on quality control:

  • of medicinal products and drug substances:
    • that are in circulation in the territory of the Republic of Belarus (medicinal products and drug products registered in the Republic of Belarus in accordance with the rules of the Union);
    • before selling in the territory of the Republic of Belarus on separate parameters for testing laboratories;
    • medicinal products made in pharmacies;
    • medicinal products (including antitubercular, antimalarial, etc.) at the request of UN agencies and other charitable organisations.
  • sampling of medicinal products for quality control.

9. Technical tests and sterility control of each batch (lot) or part of a batch (lot) of medical devices.

10. Certification of medical devices (medical devices and medical equipment) within the National System of Conformity Attestation of the Republic of Belarus, registration of declarations of compliance of medical equipment with the requirements of TR CU 020/2011.

11. Works required for the Ministry of Health to perform the following functions:

  • issuance of a certificate (authorisation) to import of registered and unregistered medicinal products and (or) drug substances restricted to movement across the State border of the Republic of Belarus on the grounds established by the laws of the Republic of Belarus;
  • issuance of a certificate (authorisation) on agreement of licences for import of narcotic drugs, psychotropic substances and their precursors into the customs territory of the Eurasian Economic Union or their export from the customs territory of the Eurasian Economic Union;
  • issuance of a permit for the sale and (or) medical use of unregistered medical devices and medical equipment on the grounds established by the laws of the Republic of Belarus;
  • issuance of a certificate confirming the purpose of the imported goods (for the purposes of determination of the duty rate);
  • issuance of a certificate on the possibility of carrying out works (services) on installation, adjustment, maintenance and repair of medical equipment and medical devices;
  • approval of advertising of:
    • medicinal products;
    • methods of medical care, works and (or) services constituting medical activity;
    • medical equipment and medical devices;
    • dietary food supplements;
    • medicinal products, medical devices and medical equipment carried out within the framework of clinical trials of these medicinal products, medical devices and medical equipment for their subsequent state registration;
  • carrying out works on the receipt, storage, registration and use of forms of Good Manufacturing Practice (GMP) certificates;
  • expert examination of documents for the possibility of issuing a certificate of pharmaceutical product (CPP) for medicinal products intended for export; registration and issuance of a CPP;
  • carrying out seminars on issues of circulation of medicinal products, medical devices and medical equipment, ensuring their safety, effectiveness and quality;
  • inspection of industrial production of medicinal products for compliance with the requirements of Good Manufacturing Practice of the Eurasian Economic Union upon request.

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