NEW PROCEDURAL RULES FOR THE CIRCULATION OF MEDICINES AND MEDICAL DEVICES

182 Volume 5, Issue 10: Special Issue (EJAR) ISSN: 2181-2020 MPHAPP THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE “MODERN PHARMACEUTICS: ACTUAL PROBLEMS AND PROSPECTS” TASHKENT, OCTOBER 17, 2025 in-academy.uz NEW PROCEDURAL RULES FOR THE CIRCULATION OF MEDICINES AND MEDICAL DEVICES Abdurakhmonova N.A. Usmanov U.X. Tashkent Pharmaceutical Institute, Tashkent city, Republic of Uzbekistan e-mail: [email protected] https://doi.org/10.5281/zenodo.17332529 Relevance: on January 21, 2022, the Decree of the President of the Republic of Uzbekistan No. PF-55 “On additional measures for the accelerated development of the pharmaceutical industry of the republic in 2022 - 2026” stipulated that, in order to further support organizations producing pharmaceutical products, from April 1, 2022, state registration of new pharmaceutical products produced by local manufacturing organizations will be carried out for an unlimited period, and previously issued registration certificates will be replaced with certificates that will be valid for an unlimited period without requiring additional documents after their expiration. However, today, in connection with the rapid implementation of the global GxP system in the country, amendments were made to the procedure for state registration of pharmaceutical products mentioned above in the Decree of the President of the Republic of Uzbekistan No. PF-137 “On Additional Measures to Regulate the Circulation of Medicines and Medical Devices” of August 19, 2025. Purpose of the study: analysis of the Decree of the President of the Republic of Uzbekistan No. PF-137. Materials and methods: the following amendments were made to the Decree of the President of the Republic of Uzbekistan No. PF-137 “On additional measures to regulate the circulation of medicines and medical equipment” of August 19, 2025:From January 1, 2026, medical devices and medical equipment will be subject to state registration as medical devices, Classification of medical devices according to 4 safety levels, taking into account the high potential risks to human life; State registration of medical devices is carried out on the basis of differentiated requirements, taking into account the high potential risks to human life; State registration of medical devices is carried out on the basis of positive results of clinical trials;local and foreign manufacturers are required to have a national certificate "Good Manufacturing Practice - GMP" for state registration of medicines and extension of the validity period of the registration certificate; based on the results of state registration of medicines and medical devices, local and foreign manufacturers are issued a registration certificate valid for five years; the production of medicines and medical devices can be carried out by manufacturers with an appropriate license on the basis of an order from their right holder through a contract (including technology transfer); the license requirement for retail sales of medical devices is abolished, and this activity is carried out with notification to the authorized body. Results in accordance with this Decree, in order to accelerate the implementation of the GxP system,When issuing a certificate of conformity for medical devices and medical equipment, from January 1, 2027, a national certificate of "Good Manufacturing Practices - GMP" will be required for medicines; for medical devices - from July 1, 2027, a certificate of conformity of the manufacturer to the national standard "ISO: 13485". These certificates are not required for orphan drugs and medical devices imported without state registration at the request of the State Health Service, drugs and medical devices used in the prevention, diagnosis and treatment of highly dangerous infections, as well as epidemiologically dangerous infections; drugs and medical devices that are subject to state 183 Volume 5, Issue 10: Special Issue (EJAR) ISSN: 2181-2020 MPHAPP THE 6TH INTERNATIONAL SCIENTIFIC AND PRACTICAL CONFERENCE “MODERN PHARMACEUTICS: ACTUAL PROBLEMS AND PROSPECTS” TASHKENT, OCTOBER 17, 2025 in-academy.uz registration through recognition; drugs and medical devices requalified by the World Health Organization. Conclusions: with this decreeAmendments and additions are made to the Law of the Republic of Uzbekistan "On Medicinal Products and Pharmaceutical Activities" and the national standard of the Republic of Uzbekistan, harmonized with the international standard "ISO:13485", is approved.