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Registration of medicinal products in Uzbekistan

State duty for registration of medicinal products in the Republic of Uzbekistan

Fees for state registration of medicinal products
№ Name of the work (service) performed Unit of measurement Price in BCA* Price in USD
1 Conducting primary (preliminary) expert evaluation of the application for registration of a medicinal product and registration documents:
1.1 Registration (re-registration) under the general procedure Per medicinal product 20 691
1.2 Registration (re-registration) under the recognition procedure Per medicinal product 19 656
1.3 Registration (re-registration) of a medicinal product prequalified by the World Health Organization (WHO) Per medicinal product 18 622
1.4 Registration (re-registration) of drug substances Per drug substance 15 518
2 Conducting a specialized expert evaluation of registration dossier for a medicinal product and laboratory tests of samples:
2.1 Original medicinal product*** Per medicinal product 299 10320
2.1.1 for each dose, each volume, different flavors and aromas per additional type 92 3176
2.1.2 for each type of primary packaging (blister, ampoule, vial, primary packaging material, etc.) per additional type 70 2417
2.1.3 for each type of secondary packaging** per additional type 50 1726
2.1.4 for each manufacturer of a drug substance per additional manufacturer 90 3107
2.1.5 for an additional production site for a finished medicinal product per additional manufacturer 80 2762
2.1.6 when there is a solvent in the kit per solvent 62 2140
2.1.7 for each type of measuring device (spoon, syringe, cup, cap, pipette, cannula, needle, etc.) per type 29 1001
2.2 Generic drug*** Per medicinal product 276 9527
2.2.1 for each dose, each volume, different flavors and aromas per additional type 92 3176
2.2.2 for each type of primary packaging (blister, ampoule, bottle, primary packaging material, etc.) per type 70 2417
2.2.3 for each type of secondary packaging** per additional type 50 1726
2.2.4 for each manufacturer of a drug substance per additional manufacturer 90 3107
2.2.5 for an additional production site for a finished medicinal product per additional manufacturer 80 2762
2.2.6 when there is a solvent in the kit per solvent 62 2140
2.2.7 for each type of measuring device (spoon, syringe, cup, cap, pipette, cannula, needle, etc.) per type 29 1001
2.3 Biological medicinal products*** (including biosimilars and biotechnology products derived from cell-based technologies) Per medicinal product 276 9527
2.3.1 for each dose, each volume, different flavors and aromas per additional type 101 3486
2.3.2 for each type of primary packaging (blister, ampoule, bottle, primary packaging material, etc.) per additional type 70 2417
2.3.3 for each type of secondary packaging** per additional type 50 1726
2.3.4 for each manufacturer of a drug substance per additional manufacturer 90 3107
2.3.5 for an additional production site for a finished medicinal product per additional manufacturer 80 2762
2.3.6 when there is a solvent in the kit per solvent 62 2140
2.3.7 for each type of measuring device (spoon, syringe, cup, cap, pipette, cannula, needle, etc.) per type 29 1001
2.4 Homeopathic medicinal product*** Per medicinal product 252 8698
2.4.1 for each dose, each volume, different flavors and aromas per additional type 102 3521
2.4.2 for each type of primary packaging (blister, ampoule, bottle, primary packaging material, etc.) per additional type 70 2417
2.4.3 for each type of secondary packaging** per additional type 50 1726
2.4.4 for each manufacturer of a drug substance per additional manufacturer 90 3107
2.4.5 for an additional production site for a finished medicinal product per additional manufacturer 80 2762
2.4.6 when there is a solvent in the kit per solvent 62 2140
2.4.7 for each type of measuring device (spoon, syringe, cup, cap, pipette, cannula, needle, etc.) per type 29 1001
2.5 Herbal medicinal product*** Per medicinal product 252 8698
2.5.1 for each dose, each volume, different flavors and aromas per additional type 102 3521
2.5.2 for each type of primary packaging (blister, ampoule, bottle, primary packaging material, etc.) per additional type 70 2417
2.5.3 for each type of secondary packaging** per additional type 50 1726
2.5.4 for each manufacturer of a drug substance per additional manufacturer 90 3107
2.5.5 for an additional production site for a finished medicinal product per additional manufacturer 80 2762
2.5.6 when there is a solvent in the kit per solvent 62 2140
2.5.7 for each type of measuring device (spoon, syringe, cup, cap, pipette, cannula, needle, etc.) per type 29 1001
2.6 Drug substances*** Per drug substance 190 6558
2.7 By recognizing or conducting a specialized expert evaluation of the registration dossier for a medicinal product prequalified by the World Health Organization (WHO) Per medicinal product 64 2209
2.7.1 for each dose, each volume, different flavors and aromas per additional type 23 794
2.7.2 for each type of primary packaging (blister, ampoule, bottle, primary packaging material, etc.) per additional type 10 346
2.7.3 for an additional production site for a finished medicinal product per additional manufacturer 10 346
2.7.4 when there is a solvent in the kit per solvent 10 346
3 Renewal of the Marketing Authorization — Consideration of the application and issuance of the certificate (without laboratory testing)*** Per medicinal product 122 4211
4 Renewal of the Marketing Authorization — Consideration of the application and issuance of the certificate (with laboratory testing)*** Per medicinal product in the amounts specified in items 1–2
5 Variations (amendments and additions) to the registration documents of a medicinal product*** Per medicinal product
5.1 Variations that do not require laboratory testing****:
5.1.1
  • change of trade name of the medicinal product (trademark symbols associated with the name of the medicinal product «®», «™», «о», «*») and/or the manufacturer, changing the name of the marketing authorization holder, additional amount and removal of additional volume
  • change in the ownership form or address (in cases where the location of the manufacturing site has not changed, including changes to the name of the city, district, street and/or building number) of the medicinal product manufacturer or the marketing authorization holder;
  • modification or addition of intermediate manufacturing sites in the manufacturing process;
  • the introduction of a new type of secondary packaging with a constant amount of the medicinal product in the primary packaging.
 Per medicinal product 73 2520
5.1.2

Changes in the manufacturing process that do not affect the information in the normative document of the medicinal product

  • make changes to the production process, change the volume of the batch, change or add excipients and packaging materials and manufacturers;
  • changes in the Active Pharmaceutical Ingredient (API) manufacturing process or laboratory analysis methods, renewal of an API Certificate of Analysis (CoA), change of the manufacturer's name or location, removing one of the manufacturers of the API, change in the manufacturing process of an excipient, amendments to its documentation, as well as changes to its qualitative and/or quantitative composition;
  • changes of the expiry date.
 Per medicinal product 73 2520
5.1.3 Making amendments to all sections of the normative document for a medicinal product that do not affect quality control methods and specifications Per medicinal product 75 2589
5.1.4 changing the mock-up of a medicinal product package (dimensions, design, font, adding information or deleting information) Per medicinal product 75 2589
5.1.5 simultaneous change of mock-up of a medicinal product and the "Labeling" section of the normative document Per medicinal product 75 2589
5.1.6 make changes to the instructions for use Per medicinal product 23 794
5.2 With the conduct of laboratory tests of samples of medicinal product, in particular****:
5.2.1
  • changes to the methods of quality control of the medicinal product and the specifications, introduction of additional control methods;
  • exclusion of dyes, flavorings, flavor additives or their replacement.
 Per medicinal product 146 5040
5.2.2
  • introduction of an additional packaging type for the dosage form (additional volume, kit packaging, addition of a measuring spoon, syringe, cup, cap, solvent, etc.);
  • change of primary packaging material;
  • addition and/or change of manufacturer within a technology transfer
  • addition of an additional manufacturing site to the registration certificate of a medicinal product manufactured under contract;
  • change of active substance manufacturers, addition of a new manufacturer or an additional production site
 Per medicinal product 127 4384
6 Variations (amendments and additions) to the registration dossiers of medicinal products registered under the recognition procedure or WHO-prequalified: Per medicinal product
6.1 to the registration certificate, normative document, packaging layout, and Common Technical Document (CTD) Per medicinal product 43 1485
6.2 to the instructions for use Per medicinal product 14 484

Notes:

  • * BCA is the Base Calculating Amount. Payments within the Republic of Uzbekistan are made in the national currency. If the applicant (or anyone acting on their behalf) is a non-resident, fees are paid in foreign currency at the exchange rate established by the Central Bank of the Republic of Uzbekistan on the date the payment slip is issued.
  • ** If the secondary packaging of the medicinal product in the application differs only in the number of primary packages of the same type, the fee shall be paid for one medicinal product package only.
  • *** For domestic manufacturers, a reduced coefficient of 82% is applied and no fee is charged for additional variations (strength, volume, types of additives and flavourings of different tastes, types of additional primary and secondary packaging, additional manufacturer, solvent and measuring devices included in the packaging).
  • **** If an application is submitted simultaneously on the basis of several items of Section I related to items 5.1.1–5.1.5, the fee for modifications and additions to the registration documents is charged in the amount specified in item 5.1.1, and in the case of submission of an application on the basis of items 5.1 and 5.2-, the fee is charged in the amount specified in item 5.2.1.
  • Price list date: 02. 05. 2026

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See also other state duties:

State duty for registration of medical devices and medical equipment in the Republic of Uzbekistan
State duty for registration of dietary supplements in the Republic of Uzbekistan
State duty for registration of food additives in the Republic of Uzbekistan
State duty for registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
State duty for registration of veterinary medicines and feed additives in the Republic of Uzbekistan

See also other products:

Medicines
Medical devices and Medical Equipment
Dietary Supplements
Food Additives
Cosmetics, Chemicals, Biological Agents and Materials, Polymers and Plastics
Veterinary Medicines

See also:

Documents required for state registration of medicines in the Republic of Uzbekistan
Documents required for state registration of medical devices and medical equipment in the Republic of Uzbekistan
Documents required for state registration of dietary supplements in the Republic of Uzbekistan
Documents required for state registration of food additives in the Republic of Uzbekistan
Documents required for state registration of cosmetics, chemicals, biological agents and materials, polymers and plastics in the Republic of Uzbekistan
Documents required for state registration of veterinary products in the Republic of Uzbekistan

See also:

List of foreign organizations whose results in terms of registration of medical equipment, medical devices and their components are recognized in the Republic of Uzbekistan from June 1, 2021
List of countries and international organizations whose results of registration of medicines are recognized in the Republic of Uzbekistan

See also departments:

Registration Department
Pharmacological Committee
Pharmacopoeial Committee
Committee on New Medical Technology (CNMT)
Laboratory for quality control and standardization of medicines
Laboratory of vaccines, serous drugs and microbiological research/a>
Laboratory for quality control of medical devices and medical equipment
Laboratory of Pharmacotoxicological Research
Department of Pharmacovigilance (PV Dept)
Department for the implementation of special digital markings
Quality Management Systems Certification Body
Reference Pricing Department

An «original drug» or original medicinal product, also known as a brand-name or innovator drug, is a medication sold by a pharmaceutical company under a specific, trademarked name, protected by a patent that prevents other companies from selling it for a set time. These drugs are typically developed, marketed, and labeled by the original manufacturer, often at a higher cost than generic versions.

A medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, and performance. They contain the same active ingredient, are equally effective, and are generally much cheaper than brand-name counterparts.