The department carries out:
- organizing a set of preliminary technical work related to state registration (confirmation of state registration) of medicinal products, state registration of pharmaceutical substances, amendments to the registration dossier of previously registered medicinal products;
- organizing a set of examinations carried out during the registration of medicinal products (confirmation of registration) and other procedures related to the registration of medicinal products for medical use in accordance with the requirements of international treaties and acts constituting the law of the Eurasian Economic Union;
- reception and examination of documents, preparation of draft permits from the Ministry of Health for the import into the Republic of Belarus (export from the Republic of Belarus) of narcotic drugs, psychotropic substances and their precursors, preparation of draft conclusions (permits) to coordinate the issuance of licenses for import into the customs territory of the Eurasian Economic Union or export from the customs territory of the Eurasian Economic Union of narcotic drugs, psychotropic substances and their precursors, draft conclusions (permits) for the export of laboratory samples for research within the framework of ongoing international multicenter clinical trials;
- reception and examination of documents, preparation of draft opinions (permits) of the Ministry of Health of the Republic of Belarus for:
- import of registered and unregistered medicines received as foreign gratuitous aid, unregistered medicines to provide medical care to a limited number of patients, to eliminate natural disasters, catastrophes, epidemic diseases;
- import by individuals of unregistered medicines for the provision of medical care for life-saving indications for the purpose of applying a special customs procedure;
- import of unregistered medicinal products intended for state registration, use as exhibition samples without the right to further sale, registered and unregistered medicinal products intended for preclinical (non-clinical) studies, confirmation of state registration without the right to further sale, as well as intended for clinical trials research (tests);
- reception and examination of documents, preparation of draft permits from the Ministry of Health for the sale of registered medicinal products in packages and (or) with instructions for medical use other than those registered in the Republic of Belarus;
- reception and review of documents for issuing an opinion for submission to the customs authorities when importing into the customs territory of the Eurasian Economic Union in the Republic of Belarus pharmaceutical substances included in registered medicinal products if the registration dossiers for medicinal products contain documents from the manufacturers of these pharmaceutical substances that meet the requirements to the documents constituting registration dossiers of medicinal products in in-bulk form, the use of granular tablet mass, tablet mass, granulated powder, granular mass for encapsulation for the production of medicinal products;
- reception and review of applications for registration of maximum selling prices of manufacturers for medicinal products, verification of documents required by law for such applications (completeness and information contained in them);
- technical support for the implementation of the administrative procedure for registering manufacturers' maximum selling prices for medicines;
- technical support for the formation and maintenance of the State Register of Medicines of the Republic of Belarus and the State Register of Maximum Selling Prices of Drug Manufacturers for Medicines, including the automated integration of information included in them, their updating;
- technical support for the formation of the Unified Register of Registered Medicines of the Eurasian Economic Union (in terms of transferring information to the Eurasian Economic Commission, provided for by the legislative acts of the Eurasian Economic Union).
