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Performs:
  • method guidance of six regional control and analysis laboratories and pharmacy depot quality office of BelPharmatsiya UE, the test laboratory of the Republican Centre of Hygiene, Epidemiology, and Public Health SI, the test laboratory of the Republican Research and Practice Centre of Epidemiology and Microbiology SI and the test laboratory of the Republican Research and Practice Centre of Haematology and Transfusion Medicine SI on the issues of quality inspection of medicinal agents and functioning of internal management systems;
  • development of draft regulatory legal acts and technical regulatory legal acts within their competence.
Carries out:
  • quality inspection of the medicinal agent registered in the Republic of Belarus pursuant to the requirements of the regulatory legal acts of the Republic of Belarus governing quality inspection of medicinal agents;
  • informing all the stakeholders about low-quality medicinal agent, drawing up and sending a draft Withdrawal Resolution to the Ministry of Health of the Republic of Belarus;
  • information collection as to the measures taken to return low-quality medicinal agent or its elimination to the manufacturer (supplier);
  • chemical analysis of the solvent (treated water) used to prepare medicinal agents extemporally produced at pharmacies;
  • preparation and supply of titrated and working solutions to pharmacies;
  • arbitration quality inspection of a medicinal agent following the resolution of the Ministry of Health of the Republic of Belarus if a legal person disagrees with the results of the previous quality inspection.