The department carries out:
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organisation and conduct of a set of preliminary technical works related to the state registration (confirmation of state registration) of medicinal products and drug substances, introduction of amendments to the registration dossiers for:
- state registration (confirmation of state registration) and issuance of the marketing authorisation for a medicinal product of domestic manufacture;
- state registration (confirmation of state registration) and issuance of the marketing authorisation for a medicinal product of foreign manufacture;
- state registration (confirmation of state registration) and issuance of the marketing authorisation for a drug substance of domestic manufacture;
- state registration (confirmation of state registration) and issuance of the marketing authorisation for a drug substance of foreign manufacture;
- state registration (confirmation of state registration) and issuance of the marketing authorisation for a drug substance of foreign manufacture submitted for state registration (confirmation of state registration) by a legal entity of the Republic of Belarus having a special permit (license) for the right to perform pharmaceutical activities;
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introduction of amendments to the registration dossier of a medicinal product (drug substance) previously registered in the Republic of Belarus:
- – in case of adding a new indication and (or) a new method of administration (introduction) into the instruction for medical use and (or) the package leaflet;
- – in case of exclusion from the instruction for medical use and (or) the package leaflet of the indication provided earlier to medical use and (or) the method of administration (introduction);
- – in case of introduction of amendments to sections of the instruction for medical use and (or) the package leaflet, including pharmacological and clinical sections;
- – in case of introduction, elimination or replacement in the composition of the medicinal product a drug substance, a filling agent, a colourant, a flavouring agent, a stabiliser, a preservative, or components of the coat of a tablet or a capsule;
- – in case of changing tests (quality indicators) specified in a monograph or a regulatory document of the manufacturer of the medicinal product (drug substance) containing indicators and methods of quality control of the medicinal product (drug substance);
- – in case of changing shelf life of the medicinal product;
- – in case of changing storage conditions of the medicinal product;
- – in case of changing methods of quality control a medicinal product and (or) a drug substance;
- – in case of changing material or appearance of primary package of a medicinal product (drug substance);
- – in case of changing the production process of the medicinal product (drug substance);
- – in case of changing the labelling of the packaging or the label of the medicinal product (drug substance);
- – in case of changing the number of doses in a package during dispensing of the medicinal product (drug substance);
- – in case of changing the name of the medicinal product (drug substance);
- – in case of reorganisation or change of the name of the manufacturer of the medicinal product (drug substance);
- – in case of change of the manufacturer (manufacturer country) of the medicinal product (drug substance);
- maintaining of the State Register of Medicinal Products (hereinafter – the State Register), updating information included in the State Register;
- carrying out expert examinations and issuance of authorisations to import and (or) export of narcotic drugs, psychotropic substances and their precursors restricted to movement across the State border of the Republic of Belarus on the grounds of non-economic nature;
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issuance of certificates (authorisations) to import of restricted to movement across the State border of the Republic of Belarus:
- registered and unregistered medicinal products and (or) drug substances for state registration (confirmation of state registration), introduction of amendments to the registration dossier intended for pre-clinical trials, clinical trials, use as exhibition samples;
- registered and unregistered medicinal products and (or) drug substances received as foreign gratuitous aid;
- registered and unregistered medicinal products intended to eliminate the consequences of natural disasters, catastrophes, epidemic diseases, to provide medical assistance during international sports events, and unregistered medicines received for treatment of limited contingent of patients with rare pathology (for individual treatment of rare and (or) particularly severe diseases);
- issuance of certificates (authorisations) on approval of licenses for import (export) to the customs territory of the Customs Union of narcotic drugs, psychotropic substances and their precursors, the import and export of which to the customs territory of the Customs Union is allowed under a license;
- carrying out registration and expert examination of medicinal products for human use in order to 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;
- acceptance and verification of documents for registration of manufacturers’ maximum selling prices 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 the registration of the manufacturer’s maximum selling prices for medicinal products;
- maintaining the State Register of Maximum Selling Prices of the Republic of Belarus and its updating;
- issuance of certificates that the imported goods relate to medicinal products or raw materials and materials for their production, components for their production, or semi-finished products to them;
- issuance of certificates (authorisations) to import of registered and unregistered medicinal products and (or) drug substances restricted to movement across the State border of the Republic of Belarus for state registration (confirmation of state registration), introduction of amendments to the registration dossier intended for conduct of non-clinical studies, clinical trials, and use as exhibition samples.
