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Importing medicines and medical devices without state registration

Some medicines and medical devices enter Uzbekistan without state registration. These are substances for production, samples for research and exhibitions, orphan drugs ordered by the Ministry of Health, humanitarian aid and goods on the shortage list. In a shortage a Ministry of Health working group decides, and the importer obtains a certificate of conformity.

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  • 3 + 5 + 5working days to a shortage decision
  • up to 2×the minimum volume in a shortage import
  • 15% / 20%markup cap, wholesale and retail, on prescription drugs

Checked against the act texts on 14.10.2026.

Medicines: when registration is not needed

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. 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

    1. 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).
    2. 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).
    3. 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).
    4. 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

Medical devices: when registration is not needed

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. Import and use without registrationRegistration exemptions (item 5), orphan and outbreak devices ordered by the Ministry of Health, humanitarian aid (item 6), temporary shortages (MoJ reg. No. 3749).

    Registration exemptions (item 5), orphan and outbreak devices ordered by the Ministry of Health, humanitarian aid (item 6), temporary shortages (MoJ reg. No. 3749).

    Registration stages

    1. 1Check exemptions: reagents inside IVD kits, custom-made devices, devices for research, clinical trials and exhibitions (item 5).
    2. 2Orphan devices and devices against highly dangerous and epidemic infections are imported on a Ministry order; humanitarian aid needs a positive Ministry conclusion (item 6).
    3. 3For shortages, Order 3749 applies: working-group decision, published list, importer selection, certification (except devices not subject to mandatory certification) (items 9-19).
    Research and exhibitions
    The exemption was added by Decree UP-74, in force since 07.05.2026.Постановление КМ № 738, прил. 2, п. 5 (в ред. УП-74, прил., п. 13)
    Export
    Export-only devices are registered only at the applicant's choice.Постановление КМ № 738, прил. 2, п. 5

    Legal basis

When registration is required

Regular sales need registration: the standard route or recognition. We pick the route for your product.

Medicine registrationRegistration by recognition

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Legislation

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Medicines (119)Medical devices and equipment (49)