PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of January 21, 2022 No. UP-55

About additional measures for the accelerated development of pharmaceutical industry of the republic in 2022 - 2026

For the purpose of further improvement of providing the population with high-quality, effective and safe pharmaceutical products, increase in production volume in pharmaceutical industry by 3 times and increases in level of security of the domestic market in kind to 80 percent due to implementation of the advanced scientific and technical achievements and innovations in this industry:

1. Approve developed by the Ministry of Health, the Ministry of investments and foreign trade, the Ministry of Finance and Agency on development of pharmaceutical industry and the assistance to the accelerated development of production of domestic pharmaceutical production directed to rendering:

Forecast parameters of development of pharmaceutical industry for 2022 - 2026 according to appendix No. 1;

The address program of the investment projects in pharmaceutical industry realized in regions in 2022 - 2024 according to appendix No. 2;

The list of the investment projects in pharmaceutical industry requiring development, coordination and approval of the preproject and project documentation in 2022 - 2026 according to appendix No. 3.

2. Form the Commission on development of pharmaceutical industry (further - the Commission) in structure according to appendix No. 4.

Commissions (Umurzakov):

till January 31, 2022 to determine measures of establishment of monthly monitoring and ensuring timely implementation of the investment projects provided by appendix No. 2 to this Decree;

in a month to determine specific measures and responsible for development of the preproject and project documentation and establishment of sources of financing of the perspective projects provided by appendix No. 3 to this Decree and also the organization of realization of project data with involvement of domestic and foreign investors;

perform coordination of activities of initiators of projects, and also the interested bodies of the public and economic board in case of implementation of investment projects;

carry out the analysis of condition of projects implementation on permanent basis, take measures for the solution of the available problematic issues and to quarterly provide to the President of the Republic of Uzbekistan information on results by projects and regions.

Authorize the Commission regularly to fill up the list of the investment projects listed in appendices No. No. 2 and 3 to this Decree at the expense of new projects, if necessary - to make changes to them, proceeding from environment and tendencies of development of the world market.

To the chairman of the board of Ministers of the Republic of Karakalpakstan, hokima of areas and city of Tashkent:

take implementation of the investment projects performed in pharmaceutical industry on personal control;

monthly together with initiators of projects to carry out discussion of implementation of each project, to regularly take measures for rendering the practical help in commissioning of project data at the scheduled time.

3. Implement since January 1, 2024 the mechanism of the guaranteed purchase of the pharmaceutical products which are subject to localization within amount of means of the Government budget planned for allocation for purchases of pharmaceutical products by the conclusion of the agreement for up to ten years based on positive results of clinical testing, processes of state registration and certification. At the same time:

The Ministry of Health develops requirements to pharmaceutical products for the guaranteed purchases;

The commission on development of pharmaceutical industry the list of international non-proprietary names of substances, medicines (in the absence of these names - names of the corresponding groups of medicines), the products of medical appointment and medical equipment which are earlier not made in the territory of the republic, localization subjects in the long term affirms (further - the list of pharmaceutical products);

the list of pharmaceutical products is placed and is regularly updated on the Special information portal of public procurements, official websites of the Ministry of Health and Agency on development of pharmaceutical industry;

the permanent working group under the Commission develops specifications on the basis of the requirements provided by the Ministry of Health;

for agreement signature of the guaranteed purchase winners are determined by holding open tenders on which the Ministry of Health is the state customer and the beneficial owner;

Advance transfer of advance payments within the signed agreements of the guaranteed purchase is allowed to the Ministry of Health and the organizations in its system.

4. Determine that:

a) in the direction of further support of producer organizations of pharmaceutical products:

since April 1, 2022 state registration of the new pharmaceutical products made by the domestic manufacturing organizations is performed for unrestricted term, earlier issued registration certificates after the expiration of their action are subject to exchange for termless certificates within 15 days without reclamation of additional documents;

since July 1, 2022 the procedure for obligatory certification of the medicines made by the domestic manufacturing organizations having the certificate of "Proper production practice" (GMP), and also the products of medical appointment and medical equipment made by the domestic manufacturing organizations having the certificate of ISO:13485, drawn up by authorized organization in the territory of the Republic of Uzbekistan is cancelled. At the same time compliance of domestic pharmaceutical production to requirements is determined by means of post-marketing supervision and voluntary certification;

SUE State Center of Examination and Standardization of Medicines, Products of Medical Appointment and Medical Equipment is allowed to make sampling with involvement of experts of regional certification bodies based on the arrived certification applications of the pharmaceutical products made in the Republic of Karakalpakstan and in areas;

b) in the direction of reduction of restrictions in pharmaceutical industry are cancelled:

prohibition on collection of donor blood and production on its basis of pharmaceutical products in private procedure;

restriction for carrying out clinical testing of medicines on healthy volunteers;

restriction for production of the medicines having identical structure, one producer under different trade names for the purpose of creation of conditions for development of production of pharmaceutical products on the basis of the international brands and the most complete operation of the operating available capacities;

c) in the direction of system implementation of the requirements ought the practician (GxP):

since April 1, 2022 new production enterprises, the organizations of wholesale and retail trade in pharmaceutical industry are created according to requirements of "Proper production practice" (GMP), "Proper distribution practice" (GDP) and "Proper pharmaceutical practice" (GPP);

terms of obligatory certification of the organizations of pharmaceutical industry and health care system of the republic ought the practician (GxP) are prolonged for compliance to requirements till January 1, 2024;

since February 1, 2022 75 percent of expenses of domestic producer organizations on carrying out registration of pharmaceutical products in the foreign states become covered from Fund of support and development of pharmaceutical industry after submission of the document confirming its registration;

since January 1, 2023 are allowed to participate in tenders for public procurements of pharmaceutical products only the organizations which organized production of medicines - according to standards of "Proper production practice" (GMP), products of medical appointment and medical equipment - according to standards "ISO: 13485", and also to the organizations of wholesale which implemented standards of "Proper distribution practice" (GDP).

5. Exempt for a period of up to January 1, 2025 from customs duties the processing and laboratory equipment which are not made in the Republic of Uzbekistan, accessories and spare parts to them, "clean rooms", sandwich panel and ventilating systems for pharmaceutical production rooms, and also the raw materials and materials, products of medical appointment and packaging materials used for content of laboratory animals, preclinical researches, the productions of medicines (including intra pharmaceutical production) imported by the producers of pharmaceutical products, the companies which are engaged in wholesale of pharmaceutical products, specialized research institutions and the highest educational institutions - for own needs, the companies which are engaged in wholesale and retail sale of pharmaceutical products - for intra pharmaceutical production of drugs, according to lists, the approved Cabinet of Ministers of the Republic of Uzbekistan.

6. Agree with the offers of khokimiyat of the Tashkent region, the Ministry of Agriculture, Ministry of water economy and Agency on development of pharmaceutical industry providing:

expansion of the territory of innovative research and production pharmaceutical cluster "Tashkent Pharma Park" (further - the Cluster) in Zangiatinsky district of the Tashkent region due to allocation in addition 80 hectares of land area in the adjacent territory;

transfer of 80 hectares of the irrigated parcels of land of agricultural purpose allocated under expansion of the territory of the Cluster to category of lands of industrial function;

not collection according to the procedure of exception of compensation payments on compensation of losses of agricultural and forestry and landscape production in case of change of category of land fund of 80 hectares of land area of agricultural purpose.

To khokimiyat of the Tashkent region (Mirzayev) in two-month time to take measures on:

to withdrawal in accordance with the established procedure at the acting users for the state and social needs and registration as state-owned property of the parcels of land specified in this Item with determination of their contours;

to allocation together with Agency on development of pharmaceutical industry (Kariyev) and the Agency according to the inventory (Umarov) of the parcel of land to Public institution "Directorate on development of innovative research and production pharmaceutical cluster of "Tashkent Pharma Park" with the right of permanent use;

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