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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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Registration of medicinal products in Uzbekistan

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

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