THE DECREE OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN
On approval of regulations on the procedure for state registration of medicines, medical devices and medical equipment and issuance of Registration Certificate
State Centre of Expertise and Standardization of medicines, medical devices and medical equipment Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan (hereinafter referred to as the State Center) is the working body of the Pharmaceutical Industry Development Agency, which ensures the state registration, quality control, standardization and certification of medicines, medical devices and medical equipment.
Registration applies to:
- new combinations of medicines registered in the Republic of Uzbekistan;
- medicines previously registered in the Republic of Uzbekistan, but produced in other medicinal forms, dosages or other manufacturer;
- medical devices;
- medical equipment.
It is not allowed to register medicinal products with different medicinal substances under the same trade name, as well as registration of medicinal products of the same manufacturer having the same composition of medicinal substances under different trade names.
Medicines and medical devices manufactured in pharmacies, as well as imported for research, pre-clinical, clinical research, state registration procedures, exhibiting at exhibitions, fairs, international forums, are not subject to registration.
Based on the results of registration of medicines, medical devices and medical equipment, issued the Registration Certificate for a period of 5 years.
The State Center is responsible for the disclosure of confidential information contained in registration documents.
The validity period of the Registration Certificate may be extended upon application submitted by the applicant to the State Center. The application for renewal of the validity of the Registration Certificate must be submitted to the State Center three months before the expiration of its validity. The renewal of the validity of the Registration Certificate is carried out in the manner provided for the issue of the Registration Certificate.
For the extension of the validity period of the Registration Certificate, a fee is collected in half the amount paid for the examination of the applicant's application for the issuance of the certificate. The fee is credited to the account of the State Center.
In case of loss or damage of Registration Certificate, a duplicate is issued at the applicant's request.
For issuance of a duplicate of the certificate, a fee is collected in half the amount paid for the consideration by the State Center of the applicant's application for the issuance of the certificate as of the date of filing the application for the issuance of a duplicate. The fee is credited to the account of the State Center.
The State Center maintains a register of issued certificates and places it on its official website.
The information contained in the register of issued certificates is open to legal and natural persons.
Upon the expiry of the validity period of the Registration Certificate, medicines, medical devices and medical equipment are permitted for sale and use in medical practice provided that they are produced during the period of validity of their Registration Certificate.
A source: ON APPROVAL OF REGULATIONS ON THE PROCEDURE FOR REGISTRATION OF MEDICINES AND MEDICAL DEVICES AND ISSUANCE OF REGISTRATION CERTIFICATE (in Russian)
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...
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...