DEPARTMENT OF REGISTRATION
TASKS OF THE REGISTRATION DEPARTMENT:
- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment;
- conducts appropriate correspondence with the applicant on the registration of medicines, medical devices and medical equipment;
- on the basis of positive results of the initial (preliminary) examination (verification) ensures the conclusion of a contract between the State Center and the applicant and draws up an invoice for payment;
- after payment by the applicant of the established fee, submits the application and attached samples and documents to the laboratories of the State Center, Pharmacological, Pharmacopoeial Committees, the Committee on New Medical Techniques, the Drug Control Committee (in the case when the drug contains narcotic drugs, psychotropic drugs substances and precursors) for examination;
Tasks of the Pharmacopoeia Committee:
- examination of normative documents for medicines subject to registration and extension of the term of registration;
- systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control;
- examination and preparation for approval of additions and amendments of the...
Tasks of the Pharmacological Committee:
- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products;
- conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts;
- decides on the use of the medicines without clinical trials in the...