REGMED

SI «The Center for Pharmaceutical Products Safety» under the Ministry of Health of the Republic of Uzbekistan (hereinafter referred to as the State Center) — is a working body of the Pharmaceutical Industry Development Agency, which ensures the implementation of state registration, quality control, standardization and certification of medicines, medical devices и medical equipment.

Subject to registration are:

• medicines;
• new combinations of medicines registered in the Republic of Uzbekistan;
• medicines previously registered in the Republic of Uzbekistan, but produced in different pharmaceutical formulations, dosages or by another manufacturer;
• biotechnology medicines produced on the basis of cell technology, previously registered in the Republic of Uzbekistan, with a changed type (autologous, allogeneic, combined), qualitative and (or) quantitative composition (except for the content of excipients), biological properties of the cell line(s), and other characteristics;
• medical devices;
• medical equipment.

The following are not required to be registered:

• substances used for the manufacture of medicines;
• medicines prepared in pharmacies;
• radiopharmaceutical preparations prepared directly in medical institutions;
• medicines imported for scientific research purposes, pre-clinical studies, clinical studies, and for demonstration at exhibitions, fairs, and international conferences;
• medicines intended for export;
• bone marrow stem cells;
• biotechnology medicines based on cell technology specially produced by a medical institution for certain patients for the purpose of fulfilling an individual medical instruction and used in this institution.
• reagents included in the kit of «in vitro» diagnostic medical devices that cannot be used as independent diagnostic tools;
• medical devices manufactured on an individual order.

Substances used for the manufacture of medicines, medicines intended for export may be registered at the request of the applicant.
Medical devices intended for export may be registered at the request of the applicant.
It is not allowed to register medicines containing different medicinal substances under the same trade name. It is allowed to register medicines containing the same medicinal substances, which are produced by the same manufacturer under different trade names on the basis of contract and technology transfer. In this case, the certificate holder may be the client or the technology transfer holder.
Orphan medicines, imported medicines and medical devices used in the prevention, diagnosis and treatment of epidemiologically dangerous infections, as well as infections posing an epidemiological danger, as ordered by the Ministry of Health of the Republic of Uzbekistan, may be imported without state registration.
Medicines and medical devices imported as foreign aid and humanitarian assistance are allowed to be imported into and used in the territory of the Republic of Uzbekistan without state registration. In this case, the Ministry of Health of the Republic of Uzbekistan shall issue a positive opinion on the import into and use of these medicines and medical devices in the territory of the Republic of Uzbekistan.
A certificate of compliance with the national requirements of the Republic of Uzbekistan for «Good Manufacturing Practices (GMP)» is required for state registration of medicines and for extending the validity period of the certificate of registration.
Medicines produced during the validity period of the registration certificate and whose registration certificate has expired shall be allowed to undergo quality control, be imported and sold for 180 calendar days after the expiration of the certificate of registration, and be used in medical practice until the expiration date. In this case, the quality control of medicines shall be carried out in accordance with the requirements of documents approved during the validity period of the certificate.
The validity period of the certificate may be extended upon application submitted by the applicant to the Center through the information system. An application for extension of the validity period of the certificate must be submitted to the Center within nine months before its expiration date. Extension of the validity period of the certificate shall be in accordance with the procedure established for registration. During the extension of the validity period of the certificate for a medicine, no laboratory tests shall be conducted unless amendments are made to the registration documents related to manufacturing processes, including the manufacturer of the active substance, the composition of excipients, packaging, quality control methods, standards, and production technology. In this case, the quality of medicines whose validity period has been extended without laboratory tests shall be subject to mandatory post-marketing control.
In the process of state registration of medical devices, the quality system of their production conditions shall be inspected for compliance with the requirements of the national standard of the Republic of Uzbekistan, harmonized with the international standard «ISO 13485», with the exception of medical devices registered under the recognition principle and in vitro diagnostic medical devices requalified (prequalified) by the WHO, and registered jointly with the WHO.
In this case, it is allowed to conduct the inspection of the manufacturer’s production conditions for compliance with the requirements of the national standard of the Republic of Uzbekistan, harmonized with the international standard «ISO 13485», simultaneously with the state registration process of the medical device. In this case, a certificate of compliance with the requirements of the national «ISO 13485» standard must be submitted before the medical device is registered by the Center.
Based on the results of registration of medicines, medical devices and medical equipment, a certificate valid for 5 years is issued.
The State Center is responsible for the disclosure of confidential information contained in registration documents.
After the validity period of the certificate, it is allowed to sell the medical devices and use it in medical practice, if they were produced during the validity period of the registration certificate.
The State Center maintains a register of issued certificates and posts it on its official website.
The information contained in the register of issued certificates is open to review by legal entities and individuals.