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Registration of medicines and medical devices by recognition in Uzbekistan

Registration by recognition is for products a strong regulator has already approved. A medicine registered by a WLA or ML4 authority passes review in 60 days with no laboratory testing and no clinical trials. A device registered by the FDA, a CE body, PMDA, MFDS or MHRA passes in 15 working days.

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  • 60 daysfor medicines: 13 + 45 + 2 days
  • 15 working daysfor medical devices
  • 0 testsno laboratory testing and no clinical trials

Checked against the act texts on 14.10.2026.

Medicines: procedure and terms

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).

  1. 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

    1. 1Confirm the registration with the reference authority (WLA or ML4) (item 3).
    2. 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).
    3. 3Deliver samples in one consumer pack with quality certificates; reference standards are not required (item 14(d)-(e)).
    4. 4Primary review takes 13 days and specialized review 45 days. No laboratory testing and no clinical trials (Annex 1; item 22(b), (d)).
    5. 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

  2. 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

    1. 1File the application and the Annex 3 dossier in the Center's system (items 14-15).
    2. 2Industrial-batch samples for testing are not required (item 14(c)).
    3. 3Primary review 13 days, specialized review 45 days; no laboratory testing and no clinical trials (Annex 1; item 22(b), (d)).
    4. 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

    Legal basis

  3. 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

    1. 1Check identity with the reference product: API manufacturer, excipients, primary packaging, control methods and technology (item 6¹).
    2. 2Only the trade name, secondary pack design and leaflet design may differ; otherwise the standard route applies (item 6¹).
    3. 3Registration by recognition without laboratory testing (item 6¹).
    4. 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

    Legal basis

  4. 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

    1. 1The product is put on a list approved by the Council coordinating cancer-control projects (PP-238, item 8(h)).
    2. 2Registration by recognition; products with a foreign authorisation, including a declaration of conformity, qualify (item 8(h)(i)).
    3. 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»

    Legal basis

Medical devices: procedure and terms

Since 01.01.2026 medical products and medical equipment are registered as medical devices (Decree UP-137, item 3). The procedure is set by the Regulation approved by Cabinet Resolution No. 738 (Annex 2). Medical devices fall into four risk classes: I, IIa, IIb, III (Regulation, item 4). Registration follows the standard procedure or recognition. The registration certificate is issued for five years (Regulation, item 8).

  1. Registration by recognitionThe device is registered by the FDA (USA), CE certificate issuing bodies (EU), the EMA (EU), PMDA (Japan), MFDS (Republic of Korea) or MHRA (UK), under item 4 of the Regulation approved by Cabinet Resolution No. 738.

    The device is registered by the FDA (USA), CE certificate issuing bodies (EU), the EMA (EU), PMDA (Japan), MFDS (Republic of Korea) or MHRA (UK), under item 4 of the Regulation approved by Cabinet Resolution No. 738.

    Registration stages

    1. 1Provide the valid foreign registration certificate or CE certificate and its expiry date (items 4, 9).
    2. 2File the application (Annex 2) and the full document set (Annex 3) electronically with the applicant's digital signature. Device samples and the materials of item 10(c), (d) are not required (items 10, 11).
    3. 3Pass the primary review in up to 2 working days and the specialised review in up to 11. The Center checks that foreign documents are genuine. If an official request gets no answer within 60 working days, registration is refused (Annex 1; item 17(c)).
    4. 4Decision and notice to the applicant. After a positive decision the certificate is sent through the information system within two working days (Annex 1; item 19).
    Review term
    15 working daysПостановление КМ № 738, прил. 2 (Положение о МИ), п. 14; приложение 1 к Положению
    Testing and inspection
    No laboratory testing, clinical trials or manufacturing inspection.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 8, 17 «б», «г», «д»
    EMA on the list
    Decree UP-77 removed EMA from the recognised list in Decree UP-6221 from 12.05.2026. Regulation No. 738 still names EMA.УП-77, прил. 4, п. 1 «а»; УП-6221, прил. 3, поз. 3; Постановление КМ № 738, прил. 2, п. 4
    Certificate validity
    5 yearsПостановление КМ № 738, прил. 2 (Положение о МИ), п. 8

    Legal basis

  2. IVD: WHO prequalification and registration in epidemicsIn vitro diagnostic medical devices (IVD): devices prequalified by the WHO and registered in cooperation with it, and devices used in epidemics and pandemics of dangerous infections.

    In vitro diagnostic medical devices (IVD): devices prequalified by the WHO and registered in cooperation with it, and devices used in epidemics and pandemics of dangerous infections.

    Registration stages

    1. 1File the application (Annex 2) and the full document set (Annex 3) electronically with the applicant's digital signature.
    2. 2Pass the primary review in up to 10 working days and the specialised review in up to 48. No laboratory testing, clinical studies or manufacturing inspection (item 17; Annex 1).
    3. 3Decision and notice to the applicant within 2 working days (Annex 1).
    Term for WHO-prequalified
    60 working daysПостановление КМ № 738, прил. 2 (Положение о МИ), п. 14; приложение 1 к Положению
    Epidemic IVDs
    30 working days; one-off registration for 1 year.Постановление КМ № 738, прил. 2 (Положение о МИ), п. 14

    Legal basis

  3. Oncology: registration by recognition from the Council's listFor medical devices not made in Uzbekistan and approved for medical use abroad, including those with a declaration of conformity. They must be intended for the Republican Specialised Scientific and Practical Medical Centre of Oncology and Radiology and be on the list approved by the Council.

    For medical devices not made in Uzbekistan and approved for medical use abroad, including those with a declaration of conformity. They must be intended for the Republican Specialised Scientific and Practical Medical Centre of Oncology and Radiology and be on the list approved by the Council.

    Registration stages

    1. 1The device is put on the list approved by the Coordinating Council for cancer control projects.
    2. 2State registration by recognition.
    3. 3Import subject to certification in the set procedure, with quality control and identification on selected parameters.
    In force from
    25.06.2026ПП-238 (дата вступления в силу по карточке lex.uz)
    Review term
    Not set.ПП-238, п. 8 «з»

    Legal basis

When recognition does not apply

If the medicine has no WLA or ML4 registration, or the device is not registered by a body listed in item 4 of the Regulation, the standard route applies. We compare both routes and propose the shorter one.

Standard route for medicinesStandard route for medical devices

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