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 executive body of the Pharmaceutical Industry Development Agency responsible for ensuring the state registration, quality control, standardization and certification of medicinal products, medical devices and medical equipment.

The following products are subject to registration:

• medicinal products;
• new combinations of medicinal products registered in the Republic of Uzbekistan;
• biotechnological medicinal products previously registered in the Republic of Uzbekistan, manufactured using cell technology and modified in terms of type (autologous, allogeneic, or combined), qualitative and/or quantitative composition (excluding excipients), or biological and other properties of the cell line;
• medical devices;
• medical equipment.

Registration is not required for the following:

• substances used for the manufacture of medicinal products;
• pharmacy-compounded medicinal products;
• radiopharmaceutical medicinal products prepared directly in healthcare institutions;
• medicinal products imported for scientific research purposes, including preclinical studies, clinical studies, and demonstration at exhibitions, fairs, and international conferences;
• medicinal products intended for export;
• bone marrow stem cells;
• cell technology-based biotechnology products specially manufactured and used in healthcare institutions for individual patients in accordance with an individual medical prescription;
• reagents included in in vitro» diagnostic medical devices that are not intended for independent diagnostic use;
• custom-made medical devices.

Upon request of the applicant, active substances intended for the manufacture of medicinal products, as well as medicinal products intended for export, may be subject to registration.
Medical devices intended for export may also be registered at the request of the applicant.
Registration is not permitted for medicinal products containing different active substances under the same trade name. Medicinal products containing identical active substances manufactured by the same manufacturer under different trade names may be registered on the basis of a contractual arrangement and technology transfer. In such cases, the marketing authorisation holder may be either the applicant or the technology transfer owner.
Import of orphan medicinal products, as well as medicinal products and medical devices intended for the prevention, diagnosis, or treatment of highly dangerous or epidemiologically significant infectious diseases, upon request of the Ministry of Health of the Republic of Uzbekistan, may be exempted from state registration.
Medicinal products and medical devices imported as humanitarian or gratuitous aid may be imported into and used within the territory of the Republic of Uzbekistan without state registration, subject to a positive decision issued by the Ministry of Health of the Republic of Uzbekistan.
For state registration of medicinal products and renewal of the registration certificate, a certificate of compliance with Good Manufacturing Practices (GMP) requirements in accordance with the national standards of the Republic of Uzbekistan is required.
Medicinal products manufactured during the validity period of an expired registration certificate may be subject to quality control, import, and distribution within 180 calendar days after expiry of the registration certificate, and may be used in medical practice until the expiry of their shelf life. Quality control shall be carried out in accordance with approved regulatory documents valid during the validity period of the certificate.
The validity of the registration certificate may be extended upon application submitted by the applicant to the Center via the information system. The application for extension of the validity of the registration certificate shall be submitted to the Center no later than nine months prior to the expiry of its validity period. The extension of the validity of the registration certificate shall be carried out in accordance with the procedure established for state 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 register is publicly accessible to legal entities and individuals.