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 normative document;
- participation in international scientific and technical cooperation in the field of standardization of medicinal products;
- preparation for publication of the State Pharmacopoeia of the Republic of Uzbekistan;
- consideration and preparation for approval of standards defining the procedure for the development and establishment of requirements for the quality of medicines, examination, preparation of conclusions and approvals for projects for state standards for medicines.
The Pharmacopoeia Committee in «On approval of regulations on the procedure for registration of medicines and medical devices and issuance of Registration Certificate», approved by the Cabinet of Ministers of 23.03.2018 №213:
- conducts examination of administrative, chemical, pharmaceutical and biological parts of registration documents of medicinal product, protocols of laboratory tests;
- requires the applicant to include in the draft normative documents of medicines alternative and (or) additional indicators, norms and test methods in order to bring them in line with national and international requirements;
- conducts examination and re-examination documents of pharmacological and (or) medicinal products with the involvement of independent experts;
- sends samples and documents of the medicinal product to the laboratories of the State Center;
- approves normative documents of medicines and medical devices;
- on the basis of submitted documents and expert opinions, submit recommendations to the Expert Council created in the established order by the Ministry of Health of the Republic of Uzbekistan (hereinafter — the Expert Council) on registration of medicinal products or on refusal to register them.
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...
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...