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
Abdu akhmono a N.A.
Usmano U.X.
Tashken Pha maceu ical Ins i u e, Tashken ci y, Republic o Uzbekis an
e-mail: [email p o ec ed]
h ps://doi.o g/10.5281/zenodo.17332529
Rele ance: on Janua y 21, 2022, he Dec ee o he P esiden o he Republic o Uzbekis an No.
PF-55 “On addi ional measu es o he accele a ed de elopmen o he pha maceu ical indus y o he
epublic in 2022 - 2026” s ipula ed ha , in o de o u he suppo o ganiza ions p oducing
pha maceu ical p oduc s, om Ap il 1, 2022, s a e egis a ion o new pha maceu ical p oduc s
p oduced by local manu ac u ing o ganiza ions will be ca ied ou o an unlimi ed pe iod, and
p e iously issued egis a ion ce i ica es will be eplaced wi h ce i ica es ha will be alid o an
unlimi ed pe iod wi hou equi ing addi ional documen s a e hei expi a ion. Howe e , oday, in
connec ion wi h he apid implemen a ion o he global GxP sys em in he coun y, amendmen s we e
made o he p ocedu e o s a e egis a ion o pha maceu ical p oduc s men ioned abo e in he
Dec ee o he P esiden o he Republic o Uzbekis an No. PF-137 “On Addi ional Measu es o
Regula e he Ci cula ion o Medicines and Medical De ices” o Augus 19, 2025.
Pu pose o he s udy: analysis o he Dec ee o he P esiden o he Republic o Uzbekis an
No. PF-137.
Ma e ials and me hods: he ollowing amendmen s we e made o he Dec ee o he P esiden
o he Republic o Uzbekis an No. PF-137 “On addi ional measu es o egula e he ci cula ion o
medicines and medical equipmen ” o Augus 19, 2025:F om Janua y 1, 2026, medical de ices and
medical equipmen will be subjec o s a e egis a ion as medical de ices, Classi ica ion o medical
de ices acco ding o 4 sa e y le els, aking in o accoun he high po en ial isks o human li e; S a e
egis a ion o medical de ices is ca ied ou on he basis o di e en ia ed equi emen s, aking in o
accoun he high po en ial isks o human li e; S a e egis a ion o medical de ices is ca ied ou on
he basis o posi i e esul s o clinical ials;local and o eign manu ac u e s a e equi ed o ha e a
na ional ce i ica e "Good Manu ac u ing P ac ice - GMP" o s a e egis a ion o medicines and
ex ension o he alidi y pe iod o he egis a ion ce i ica e; based on he esul s o s a e egis a ion
o medicines and medical de ices, local and o eign manu ac u e s a e issued a egis a ion ce i ica e
alid o i e yea s; he p oduc ion o medicines and medical de ices can be ca ied ou by
manu ac u e s wi h an app op ia e license on he basis o an o de om hei igh holde h ough a
con ac (including echnology ans e ); he license equi emen o e ail sales o medical de ices is
abolished, and his ac i i y is ca ied ou wi h no i ica ion o he au ho ized body.
Resul s in acco dance wi h his Dec ee, in o de o accele a e he implemen a ion o he GxP
sys em,When issuing a ce i ica e o con o mi y o medical de ices and medical equipmen , om
Janua y 1, 2027, a na ional ce i ica e o "Good Manu ac u ing P ac ices - GMP" will be equi ed o
medicines; o medical de ices - om July 1, 2027, a ce i ica e o con o mi y o he manu ac u e o
he na ional s anda d "ISO: 13485". These ce i ica es a e no equi ed o o phan d ugs and medical
de ices impo ed wi hou s a e egis a ion a he eques o he S a e Heal h Se ice, d ugs and
medical de ices used in he p e en ion, diagnosis and ea men o highly dange ous in ec ions, as
well as epidemiologically dange ous in ec ions; d ugs and medical de ices ha a e subjec o s a e
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
egis a ion h ough ecogni ion; d ugs and medical de ices equali ied by he Wo ld Heal h
O ganiza ion.
Conclusions: wi h his dec eeAmendmen s and addi ions a e made o he Law o he Republic
o Uzbekis an "On Medicinal P oduc s and Pha maceu ical Ac i i ies" and he na ional s anda d o
he Republic o Uzbekis an, ha monized wi h he in e na ional s anda d "ISO:13485", is app o ed.
