Medicine registration in Uzbekistan 2026: the recognition route
Medicine registration in Uzbekistan: a 60-day recognition route for products approved by WLA or ML4 regulators, Decree UP-137, the UP-191 change and Res. 738.
Short answer
Since 1 October 2025, Uzbekistan has registered medicines already approved by regulators on the WHO Listed Authorities (WLA) list, or by authorities at Maturity Level 4 (ML4) of the WHO Global Benchmarking Tool, through a recognition procedure. The legal basis is Presidential Decree UP-137 of 19 August 2025. The details are in the registration regulation approved by Cabinet of Ministers Resolution No. 738 of 24 November 2025, in force since 26 February 2026: the recognition route has a 60-day review period, against 210 days in the general procedure.
What changed in September 2026
Decree UP-191 of 10 September 2026 (in force 16 September 2026) mainly reforms medical and pharmaceutical education, but its Annex 4 deleted the words “until the date this Decree enters into force” from point 2(a) of UP-137. Recognition based on WLA regulators is therefore no longer tied to the list as it stood when UP-137 took effect on 23 August 2025; the point now refers to the WHO Listed Authorities list as such. Point 2(b) on ML4 authorities is unchanged.
Who applies and what to file
The applicant is the manufacturer, the certificate holder or a legal entity acting for them under a power of attorney; the file goes to the Center for Pharmaceutical Product Safety under the Ministry of Health. The dossier is submitted in ICH CTD electronic format. On the recognition route, samples from three batches and reference standards are not required; one consumer pack with quality certificates is filed instead. Laboratory testing and clinical trials are not required, but the preliminary review and the authenticity check of certificates still apply.
Timelines and validity
The 60-day and 210-day periods exclude the 45 days allowed to fix deficiencies found at preliminary review, the 90 days allowed for deficiencies found at specialised review, and time spent waiting for official replies from foreign authorities. The registration certificate is valid for 5 years. Priority review applies to medicines with no registered analogue in the country, orphan medicines, medicines urgently needed on the domestic market at the Ministry's request, and the first analogue of an original medicine.
GMP and import certification
Under UP-137, a national GMP certificate has been required for registration and renewal since 1 January 2026 (subject to the exceptions listed in the decree), and from 1 January 2027 a national GMP certificate by product type will also be required for the certificate of conformity. Products registered by recognition and WHO-prequalified products are exempt from the GMP/ISO 13485 certificate requirement when the certificate of conformity is issued. Certification of pharmaceutical products follows state registration, and the application is filed electronically through the State Customs Committee's Single Window system (Ministry of Health Order, reg. No. 3386, 12 September 2022).
Role of the Agency
The Medicine and Pharmaceutical Industry Development Agency under the Ministry of Health is an industry-development body; registration and the State Register are handled by the Center for Pharmaceutical Product Safety. The UP-137 action plan makes the Agency responsible for pharmacovigilance rules, bioequivalence procedures and clinical-trial rules, and, together with the Ministry, for a list of products that may be imported without registration until 1 January 2030 (due December 2026). Before filing, check that your reference regulator is on the current WLA or ML4 list. CSC follows registration and import procedures in Uzbekistan; to request a quote, please use the Medicine Request Form on our website.
Source: Decree of the President of Uzbekistan UP-137 of 19.08.2025, points 2, 4, 5, 6 and Annex 1 (lex.uz/docs/7697214); Decree UP-191 of 10.09.2026, Annex 4 point 5(a) (lex.uz/docs/8481128); Cabinet of Ministers Resolution No. 738 of 24.11.2025, registration regulation clauses 2, 3, 9, 11, 14, 19, 22 (lex.uz/docs/7853907); Ministry of Health Order reg. No. 3386 of 12.09.2022 (GRATA International summary); Medicine and Pharmaceutical Industry Development Agency (gov.uz/uzpharmagency).