All services
Medicine registration in Uzbekistan
New medicines, generics and biologics: from dossier to certificate.
Get a consultationRegistration by Recognition in Uzbekistan: 60 days
Registration pathways
Medicines are registered by the Center for Pharmaceutical Product Safety under the Ministry of Health, under the Regulation approved by Cabinet Resolution No. 738 (in force since 26.02.2026). The Regulation sets two main routes: standard registration and registration by recognition (item 3). Some categories get shorter terms, priority, or import without registration. The certificate is valid for 5 years (item 11).
Standard registrationFor any medicine that does not qualify for recognition: originators, generics, biosimilars, new combinations, new forms, strengths or manufacturers (item 5).
For any medicine that does not qualify for recognition: originators, generics, biosimilars, new combinations, new forms, strengths or manufacturers (item 5).
Registration stages
- 1File the application and an ICH CTD e-dossier in the Center's information system, signed with the e-signature of a representative holding a degree in pharmacy, medicine, chemistry or biology (item 14(a)-(b); item 15).
- 2Deliver samples from one industrial batch, enough for three rounds of testing, with at least 50% remaining shelf life, plus reference standards (item 14(c), (e); item 16).
- 3Pass primary review: dossier completeness, authenticity of foreign certificates, trademark rights via the Ministry of Justice portal. The applicant gets 45 days to fix deficiencies (item 22(a)).
- 4Laboratory testing and specialized review by scientific commissions run in parallel. The applicant gets 90 days to answer deficiency letters (item 22(b)-(c)).
- 5Run clinical trials unless the Center waives them, and present the national GMP certificate before registration; inspection of a foreign site may run in parallel (item 22(d); item 11).
- 6Receive the decision. The certificate, approved company monograph, pack mock-ups and leaflet are sent through the system within 2 working days of the decision (items 23-24).
- Review term
- 210 days: primary review 30 days, laboratory testing 75 days, specialized review 90 days, decision 15 days. The act does not say whether these are calendar or working days.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 19; приложение 1 к Положению
- Clock stops
- The 45- and 90-day deficiency periods, clinical trials (up to 1 year for generics, up to 3 years for originators), GMP assessment, and waiting for a foreign authority's reply.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 19
- Certificate validity
- 5 yearsПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 11
- Fee
- The Ministry of Health sets the amount in agreement with the Ministry of Economy and Finance, the business ombudsman and the Chamber of Commerce. It is not refunded on withdrawal or refusal. The act gives no figure.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 18 (в ред. ПП-238)
- Generic bioequivalence
- Studies to ICH requirements become mandatory from 01.01.2029.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 22 «г»
- Data protection
- Confidential dossier data for a product with a new chemical entity stay undisclosed for 6 years from registration without the applicant's consent.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 17
Legal basis
- Постановление Кабинета Министров, № 738, 24.11.2025, прил. 1 (Положение о ЛС), п. 3, 5, 11, 14-25; приложения 1 и 3 к Положению
- Указ Президента, № УП-137, 19.08.2025, п. 4 «а», «б»
- Приказ министра здравоохранения, № 7 (рег. МЮ № 3848 от 04.06.2026), 30.04.2026, Инструкция о требованиях к документам для регистрации ЛС (в силе с 06.09.2026), в целом
Registration by recognitionThe product is registered by a WHO Listed Authority or by a regulator at Maturity Level 4 under the WHO Global Benchmarking Tool. The route applies from 01.10.2025 (Decree UP-137, item 2; Regulation, item 3).
The product is registered by a WHO Listed Authority or by a regulator at Maturity Level 4 under the WHO Global Benchmarking Tool. The route applies from 01.10.2025 (Decree UP-137, item 2; Regulation, item 3).
Registration stages
- 1Confirm the registration with the reference authority (WLA or ML4) (item 3).
- 2File the application and the full Annex 3 dossier, except drug substance master files; labelling may be in another country's language (Annex 3, note and item 1.6).
- 3Deliver samples in one consumer pack with quality certificates; reference standards are not required (item 14(d)-(e)).
- 4Primary review takes 13 days and specialized review 45 days. No laboratory testing and no clinical trials (Annex 1; item 22(b), (d)).
- 5Decision within 2 days; the certificate is sent through the system (Annex 1; item 24).
- Review term
- 60 days (13 + 45 + 2)Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 19; приложение 1 к Положению
- Laboratory testing
- Not performedПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 22 «б»
- Clinical trials
- Not requiredПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 22 «г»
- National GMP certificate
- The exemption is worded for products 'registered by recognition, prequalified by WHO'. The text does not make clear whether it covers every recognition product.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 11, абз. 4; УП-137, п. 4 «а»
- Certificate validity
- 5 yearsПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 11
Legal basis
- Постановление Кабинета Министров, № 738, 24.11.2025, прил. 1 (Положение о ЛС), п. 3, 11, 14 «г», «д», 19, 22 «б», «г»; приложения 1 и 3 к Положению
- Указ Президента, № УП-137, 19.08.2025, п. 2 (в ред. УП-191), п. 4 «а»
- Указ Президента, № УП-191, 10.09.2026, п. 5 «а» (изменение п. 2 «а» УП-137; в силе с 16.09.2026)
Registration of WHO-prequalified medicinesThe product is WHO-prequalified and is registered in cooperation with WHO (item 19, item 22(b)).
The product is WHO-prequalified and is registered in cooperation with WHO (item 19, item 22(b)).
Registration stages
- 1File the application and the Annex 3 dossier in the Center's system (items 14-15).
- 2Industrial-batch samples for testing are not required (item 14(c)).
- 3Primary review 13 days, specialized review 45 days; no laboratory testing and no clinical trials (Annex 1; item 22(b), (d)).
- 4Decision within 2 days (Annex 1).
- Review term
- 60 daysПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 19; приложение 1 к Положению
- National GMP
- Not required for WHO-prequalified products registered by recognition.УП-137, п. 4 «а»; Постановление КМ № 738, прил. 1, п. 11
Recognition for contract-made local medicinesA local manufacturer's registered product is made under contract with the same composition but a different trade name. Introduced by Decree UP-35, in force since 07.03.2026 (item 6¹).
A local manufacturer's registered product is made under contract with the same composition but a different trade name. Introduced by Decree UP-35, in force since 07.03.2026 (item 6¹).
Registration stages
- 1Check identity with the reference product: API manufacturer, excipients, primary packaging, control methods and technology (item 6¹).
- 2Only the trade name, secondary pack design and leaflet design may differ; otherwise the standard route applies (item 6¹).
- 3Registration by recognition without laboratory testing (item 6¹).
- 4The first industrial batch or batches undergo mandatory post-marketing control (item 6¹).
- Laboratory testing
- Not performedПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 6¹ (введен УП-35)
- Review term
- Item 6¹ sets no separate term. Item 19 gives 60 days for recognition.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 6¹, п. 19
One-off registration of vaccines during epidemicsVaccines used during an epidemic or pandemic of infections that pose an epidemiological threat (item 19).
Vaccines used during an epidemic or pandemic of infections that pose an epidemiological threat (item 19).
Registration stages
- 1File the application and dossier in the Center's system (items 14-15).
- 2The Center reviews the application on a shortened term (item 19).
- 3Registration is granted once, for one year (item 19).
- Review term
- 30 daysПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 19
- Registration term
- 1 year, one-offПостановление КМ № 738, прил. 1 (Положение о ЛС), п. 19
Priority registration (including orphan medicines)A product with no registered analogue, an orphan medicine, a product in high demand at the Ministry of Health's request, or the first analogue of an originator (item 9).
A product with no registered analogue, an orphan medicine, a product in high demand at the Ministry of Health's request, or the first analogue of an originator (item 9).
Registration stages
- 1Check that the product falls under an item 9 category and appears on the priority list on the Center's website (item 9; resolution item 2(d)).
- 2File under the standard route or by recognition (items 3, 14).
- 3The Center handles the application with priority (item 9).
- Shortened term
- The act sets no separate term for priority registration.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 9, 19
- Priority list
- The Ministry of Health keeps the list published on the Center's website.Постановление КМ № 738, п. 2 «г»
Oncology: recognition under the Council list (PP-238)Newest oncology, haematology, immunology, pain and supportive-care medicines that are not made in Uzbekistan and are authorised abroad, for use at the Republican oncology center (PP-238, item 8(h)).
Newest oncology, haematology, immunology, pain and supportive-care medicines that are not made in Uzbekistan and are authorised abroad, for use at the Republican oncology center (PP-238, item 8(h)).
Registration stages
- 1The product is put on a list approved by the Council coordinating cancer-control projects (PP-238, item 8(h)).
- 2Registration by recognition; products with a foreign authorisation, including a declaration of conformity, qualify (item 8(h)(i)).
- 3Alternative: import subject to certification on selected quality parameters and identification (item 8(h)(ii)).
- In force from
- 25.06.2026ПП-238 (дата вступления в силу по карточке lex.uz)
- Review term
- PP-238 sets no term. Regulation No. 738 (as of 03.07.2026) does not describe this procedure.ПП-238, п. 8 «з»
Import and use without registrationRegistration exemptions (item 7), orphan and outbreak-response medicines ordered by the Ministry of Health, humanitarian aid (item 8), and temporary shortages (MoJ reg. No. 3749).
Registration exemptions (item 7), orphan and outbreak-response medicines ordered by the Ministry of Health, humanitarian aid (item 8), and temporary shortages (MoJ reg. No. 3749).
Registration stages
- 1When a shortage arises, national clinics, associations, wholesalers, the Agency or Ministry units report it with a 3-month minimum quantity (Order 3749, items 3-4).
- 2The working group reviews the data in 3 working days, agencies study it in 5 working days, and the group decides in 5 working days (items 5-9).
- 3The list is posted on the Ministry's website within 1 working day; importers bid within 15 days (extendable by 15) with foreign registration, specification, price and a marking commitment (items 15-16).
- 4The working group issues its conclusion in 3 working days; the importer obtains a conformity certificate under Rules No. 3386 and clears customs (items 17-19).
- Exempt from registration
- Substances for manufacturing, pharmacy compounding, in-hospital radiopharmaceuticals, research and exhibition samples, export goods, bone-marrow stem cells, individual cell-therapy products.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 7
- Orphan and outbreak products
- Import without registration on a Ministry of Health order; humanitarian aid with a positive Ministry conclusion.Постановление КМ № 738, прил. 1 (Положение о ЛС), п. 8
- Shortage volume and mark-ups
- Import up to twice the minimum quantity; mark-up on prescription products capped at 15% wholesale and 20% retail.Приказ МЗ (рег. МЮ № 3749), Положение, п. 22
- List for import without registration until 2030
- The Ministry of Health is to approve a list of medicines and products imported without registration, with mandatory certification, until 01.01.2030; the act is due in December 2026.УП-137, прил. 1, поз. 6¹ (дополнена УП-191)
Legal basis
- Постановление Кабинета Министров, № 738, 24.11.2025, прил. 1 (Положение о ЛС), п. 7, 8
- Приказ министра здравоохранения, № 24 (рег. МЮ № 3749 от 09.01.2026), 05.01.2026, Положение, п. 2-24 (в силе с 12.01.2026)
- Указ Президента, № УП-137, 19.08.2025, прил. 1, поз. 6¹
- Указ Президента, № УП-191, 10.09.2026, п. 5 «б»
Related procedures
- RenewalFile 9 months before the certificate expires; review follows registration rules. With no manufacturing or quality changes there is no lab testing (135 days) and the product goes to mandatory post-marketing control. With quality-related changes the term is 210 days. For 180 calendar days after renewal, supply under the old documents is allowed. Dossier sections 1-3 are submitted.Постановление КМ № 738, прил. 1, п. 34; приложение 1 к Положению (примечания ** и ***); приложение 3, примечание
- VariationsFiled through the system with documents and, if needed, samples. Term is at most 50% of the registration term; the rule does not apply to recognition products. The Ministry of Health sets the fee. For 180 calendar days after the decision, production and import under the old data are allowed. A new contract or transfer site is added after testing and GMP inspection.Постановление КМ № 738, прил. 1, п. 29-31
- Certificate reissueAfter a reorganisation or name change with the same site and technology, apply within 1 month. The Center reissues within 5 working days, free of charge.Постановление КМ № 738, прил. 1, п. 32-33
- Suspension and cancellationArticles 32-34 of the Law on licensing, permit and notification procedures apply. A single breach of certain item 13 conditions counts as gross and is grounds for cancellation.Постановление КМ № 738, прил. 1, п. 35-36
- Sales after expiryProduct made while the certificate was valid may be imported and sold for 180 calendar days after expiry and used until its shelf life ends.Постановление КМ № 738, прил. 1, п. 28
- Drug substancesRegistering substances used in manufacturing is optional, at the applicant's choice. Review term is 45 days.Постановление КМ № 738, прил. 1, п. 7, 19
- Unproven efficacyFrom 05.07.2026, Ministry scientific commissions flag products whose efficacy was studied but not proven, or not studied. Unproven efficacy is a ground for refusal.Приказ МЗ № 6 (рег. МЮ № 3806), Положение, п. 2-11; Постановление КМ № 738, прил. 1, п. 25
How registration works
Consultation
We review the product and documents and give a timeline and price.
Contract
We fix the scope, schedule and people responsible.
Dossier
We collect documents, translate them and build the dossier to the rules.
Submission and review
We submit the dossier, answer queries and follow the testing.
Certificate
We hand over the certificate and remind you about renewal in advance.
Registration package
- Manufacturer's GMP certificate
- Certificate of Pharmaceutical Product (CPP)
- Patient leaflet and pack artwork
- Quality control specification
- Samples for laboratory testing
The exact list depends on the product. We check your documents at the consultation.
Legislation
Acts from the knowledge base for this product type.
- Presidential Decree · No. UP-191 · 10 September 2026Medical and pharmaceutical training reform — pharmaceutical-circulation amendments in the annex
- Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
- Presidential Decree · No. UP-77 · 5 May 2026Improving management efficiency in the healthcare system
- Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents
- Order of the Minister of Health · No. 2 · 14 April 2026Procedure for inspecting the manufacturing conditions of medical devices during state registration
- Cabinet of Ministers Resolution · No. 738 · 24 November 2025State-registration procedures for medicines and medical devices
- Order of the Minister of Health · No. 12 · 21 October 2025Classifiers of key medicinal-product pharmacological characteristics
- Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices