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Main  //  Departments  //  Department of Medicinal Preparations  //   Functions
Organises and performs a set of works to maintain and perform expert examination of the registration file for:
  • state registration (re-registration) and issuance of the registration certificate of the medicinal agent domestically produced or produced abroad;
  • state registration (re-registration) and issuance of the registration certificate of the pharmaceutical substance domestically produced or produced abroad;
  • state registration (re-registration) and issuance of the registration certificate of the pharmaceutical substance produced abroad submitted for state registration (re-registration) by a legal person of the Republic of Belarus having a special permit (licence) for pharmaceutical activity;
  • amending the registration file of the medicinal agent (pharmaceutical substance) previously registered in the Republic of Belarus:
    • in the case of introducing a new indication and (or) new method of application (introduction) to the instructions of medical use of a medicinal agent and (or) package leaflet;
    • in the case of exclusion from the instructions of medical use and (or) package leaflet of the previous indication of medical use and (or) method of application (introduction);
    • in the case of amending sections of the instructions of medical use of a medicinal agent and (or) package leaflet, except pharmacological and clinical sections;
    • in the case of introduction, exclusion or replacement of a filler, colourant, flavouring agent, stabiliser, preservative, components of the tablet or capsule shell;
    • in the case of amending the texts of the pharmacopoeia article or regulatory document of the medicinal agent (pharmaceutical substance) manufacturer containing indices and methods of control over the quality of a medicinal agent (pharmaceutical substance);
    • in the case of amendment of the best before date of the medicinal agent;
    • in the case of amendment of the storage conditions of the medicinal agent;
    • in the case of amendment of the quality control methods of a medicinal agent and (or) pharmaceutical substance;
    • in the case of amendment of the material or type of the initial packing of the medicinal agent (pharmaceutical substance);
    • in the case of amendment of the production process of the medicinal agent (pharmaceutical substance); in the case of amendment of the medicinal agent (pharmaceutical substance) package or label marking;
    • in the case of amendment of the number of doses in the package while packing the medicinal agent (pharmaceutical substance);
  • issuance of the permit to import and (or) export narcotic substances, psychotropic substances and their precursors with limitations in movement across the customs border of the Republic of Belarus on non-economic grounds;
  • issuance of the permit to import the following with limitations in movement across the customs border of the Republic of Belarus on non-economic grounds:
    • non-registered medicinal agents (pharmaceutical substances);
    • non-registered medicinal agents (pharmaceutical substances) received as foreign grant assistance;
  • issuance of licences to import and (or) export to the customs territory of the Customs Union:
    • narcotic substances, psychotropic substances and their precursors which import to and export from the customs territory of the Customs Union is permitted on the basis of a licence;
    • of human organs and bodies, blood and its components limited for movement across the customs border of the Customs Union in the case of import and (or) export.