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: nargiza_24.10.1975@mail.ru
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 div.
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.
