PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of January 28, 2025 No. UP-13

About additional measures for the accelerated development of pharmaceutical industry

For the purpose of the accelerated development of pharmaceutical industry, essential increase in export volume and investments involved to the sphere, and also implementation of new management system for providing the population with high-quality medicines which safety and efficiency are guaranteed:

1. Assign to Agency on development of pharmaceutical industry under the Ministry of Health (further - the Agency) the following additional tasks:

development of the industry of dietary supplements and cosmetic products, including studying, the analysis of market situation, production localization, assistance to implementation of front lines foreign the practician and standards at the industry companies in this direction;

implementation of monitoring and accounting of investment projects of the regional pharmaceutical companies together with local khokimiyats;

digitalization of pharmaceutical industry and implementation of information programs.

2. Establish procedure according to which since April 1, 2025:

a) limiting trade margins are imposed only to category of the medicines provided according to the recipe. At the same time:

the operating system of forming of the reference prices of domestic and foreign medicines remains;

in case of wholesale and retail sale of category of the medicines provided according to the recipe surcharge in the amount of no more than 15 percent to the purchase (basic) price for wholesale trade and no more than 20 percent to purchase price for retail trade, irrespective of the number of the intermediaries participating in their delivery is imposed. Wholesale and retail prices on these medicines shall not exceed the marginal wholesale and retail reference prices;

limiting trade margins do not extend to wholesale and retail sale of the medicines provided without recipe;

b) in case of production of medicines of similar structure under different trade names by the same producer, to all these medicines applies the lowest reference price (except as specified in case of which there is distinction in producers of medicinal substances (substances);

c) Public institution "Center of safety of pharmaceutical products" under the Ministry of Health automatically (without request of the entrepreneur) reviews the reference prices fixed in foreign currency, in the following cases:

if the foreign exchange rate in relation to national currency exceeds the last cost established for medicine for 3 percent - annually in January and July;

if the foreign exchange rate in relation to national currency exceeds the last cost established for medicine for 5 percent - ahead of schedule.

3. To the Ministry of Health (A. Hudayarov) until the end of 2025 to take measures for carrying out laboratory of the Center of safety of pharmaceutical products through the procedure of prekvalifikation (prequalification) of the World Health Organization.

4. For the purpose of growth in volumes of export of pharmaceutical products by fund of assistance to trade:

a) on the basis of the rating of stability of the pharmaceutical companies:

refund 100 percent of the expenses connected with registration of one of medicines of the domestic manufacturing companies in the Food and Drug Administration (FDA) organization of the USA or the European Medicines Agency organization (EMA) of the European Union, after sight documents, confirming its registration;

refund 50 percent of the expenses connected with registration of pharmaceutical products of the domestic manufacturing companies in the foreign states after sight of documents, confirming its registration;

b) enter procedure for 100 percent advance payment of expenses on participation in prestigious international exhibitions and fairs with stands in the field of pharmaceutics to the industry companies for the request of the Agency.

To the Cabinet of Ministers to approve Regulations on application of the measures provided by this Item in a month.

5. Agree with the offer of JSC Asakabank and Agency on creation in two-month time in case of establishment of JSC Asakabank of venture fund in the form of the limited liability company with authorized fund in the equivalent equal to 10 million US dollars financing startup projects in such directions of pharmaceutics as biopharmaceutics, cellular technologies, oncology.

6. To fund of reconstruction and development, JSC Asakabank and the Agency to organize the Investment fund of perspective projects of pharmaceutical industry (further - the Investment fund) under JSC Asakabank without formation of legal entity. At the same time:

The fund of reconstruction and development deposits in the Investment fund funds in the amount of 50 million US dollars and JSC Asakabank - 50 million US dollars;

Equity in scientific and applied and investment projects in the field of pharmaceutics is allowed to investment fund;

forming of means of the Investment fund is performed depending on approval of investment projects of pharmaceutical industry;

feasibility statements on the projects financed by means of the Investment fund pass the examination of Scientific and technical council under the Agency, and import contracts within the project - SUE Center of Complex Examination of Projects and Import Contracts.

To fund of reconstruction and development, JSC Asakabank and the Agency in two-month time to submit in accordance with the established procedure in the Cabinet of Ministers for approval Regulations on the Investment fund of perspective projects of pharmaceutical industry.

7. And finance to provide to the ministry of the higher education, science and innovations, the Ministry of Economics annual allocation till 2030 of funds at the rate to 20 billion sum at the expense of the means allocated from the Government budget to Fund of science funding and support of innovations for state programs on scientific activities for the purpose of inclusion in programs of incubation and acceleration, and also the financing of scientific projects of the Agency of innovative development allocated for creation of domestic medicines and its startup projects in pharmaceutical industry.

8. Agree with the offer of the Ministry of Health on export of plasma of donor blood out of limits of the Republic of Uzbekistan until the end of 2027 for the purpose of production on contractual basis of medicines from plasma of donor blood based on the conclusion of the Ministry of Health and the Agency. At the same time to determine that surplus of the medicines made from plasma of donor blood over requirements of the Ministry of Health can be realized (are exported) to the foreign states.

To the Ministry of Health (A. Hudayarov) till March 1, 2025 to introduce to the Cabinet of Ministers the draft of the corresponding order of the Government determining procedure for provision of the export permit of plasma of donor blood out of limits of the Republic of Uzbekistan for the purpose of production of medicines from plasma of donor blood and also for export of the medicines made from plasma of donor blood to the foreign states.

9. To the Ministry of Health (A. Hudayarov) together with the Agency (A. Azizov), Project office "Center of projects of health care" (E. Adilov), Academy of Sciences (Sh. Turdikulov) till July 1, 2025 to develop and introduce in the Cabinet of Ministers the relevant acts of the legislation on production organization of biotechnological medicines on the basis of cellular technologies.

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