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Active measures are being taken in the Republic of Uzbekistan ("Uzbekistan") to develop the pharmaceutical industry. In particular, in order to provide the population with effective, high-quality and safe pharmaceutical products, as well as to develop the production of domestic pharmaceuticals, the President has signed a Decree "On Additional Measures to Accelerate the Development of the Pharmaceutical Industry of Uzbekistan in 2022-2026" No. UP-55 dated 21.01.2022 (the "Decree").

The Decree provides for the introduction of additional measures to ensure further support of domestic pharmaceutical manufacturers, the lifting of a number of prohibitions and restrictions in the pharmaceutical industry, including the introduction of an exemption from customs duties on the import of technological and laboratory equipment not manufactured in Uzbekistan, as well as the introduction of the requirements of the system of Good Practice ("GxP") in order to ensure the proper quality of manufactured pharmaceutical products. The President approved the Roadmap for the further development of the pharmaceutical industry in 2022-2026, developed and approved a Program of investment projects in the pharmaceutical industry implemented in the regions in 2022-2024, as well as amendments and additions to a number of legislative regulatory acts of Uzbekistan regulating pharmaceutical activities.

In this issue of the newsletter, we review the key new amendments provided for by the adopted Decree.

AMENDMENTS AIMED AT SUPPORTING DOMESTIC PHARMACEUTICAL MANUFACTURERS

From April 1, 2022, there will be no validity period of the state registration of new pharmaceutical products produced by domestic manufacturers. All new registration certificates for new pharmaceutical products will be issued for an unlimited period. All previously issued registration certificates are subject to exchange for indefinite certificates within 15 days upon expiration of their validity without the need for additional documents.

From July 1, 2022, mandatory certification is cancelled for:

• Medicines produced by domestic manufacturers that have a certificate of Good Manufacturing Practice (“GMP”);
• Medical equipment and pharmaceutical products manufactured by domestic manufacturers with an ISO:13485 certificate issued by an authorized organization in the territory of Uzbekistan.

The Decree provides that compliance of domestic pharmaceutical products with the requirements be determined through post-marketing supervision and voluntary certification.

The State Unitary Enterprise State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment is authorized to conduct sampling, based on received applications for certification of pharmaceutical products produced by domestic manufacturers, with the involvement of experts from regional certification authorities.

REMOVAL OF PROHIBITIONS AND RESTRICTIONS IN THE PHARMACEUTICAL INDUSTRY

The Decree has allowed:

• the collection of donor blood for the manufacture of medicines in a private manner;
• conducting clinical trials of medical products on healthy volunteers;
• the production of medicines of the same composition by the same manufacturer under different trade names. Thus, the Decree has provided for the creation of favorable conditions for the development of pharmaceutical production based on international brands.

IMPLEMENTATION OF THE REQUIREMENTS OF GXP (GOOD PRACTICE). RESTRICTIONS AND INCENTIVES RELATED TO GXP REQUIREMENTS

From April 1, 2022 until January 1, 2024, the establishment of new manufacturing enterprises, as well as organizations of wholesale and retail trade in pharmaceutical products, requires mandatory certification for compliance with the following requirements:

• Good Manufacturing Practice ("GMP");
• Good Distribution Practice ("GDP");
• Good Pharmacy Practice ("GPP");

At the same time, from January 1, 2023, organizations will be allowed to participate in tenders for public procurement of pharmaceutical products if they have ensured:

• the production of medicines according to GMP standards;
• the production of medical devices and medical equipment according to ISO:13485 standard;
• wholesale sale of medicines taking into account the implementation of GDP standards.

From February 1, 2022, 75% of the expenses spent on the registration of pharmaceutical products of domestic manufacturers in foreign countries will be compensated to manufacturers by the Fund for the Support and Development of the Pharmaceutical Industry, provided that a registration document is supplied by the applicant.

Until January 1, 2025, the following products are exempt from customs duties:

• technological and laboratory equipment not produced in Uzbekistan, components and spare parts for them, "clean rooms", sandwich panels and ventilation systems for pharmaceutical production facilities;
• raw materials, medical devices and packaging materials imported by pharmaceutical manufacturers, enterprises engaged in the wholesale sale of pharmaceutical products, specialized research institutes and higher educational institutions - for their own needs, as well as enterprises engaged in the wholesale and retail sale of pharmaceutical products - for the intra-pharmacy manufacture of medicines, according to the lists approved by the Cabinet of Ministers of Uzbekistan.

SUPPORT OF DOMESTIC ORGANIZATIONS SELLING PHARMACEUTICAL PRODUCTS FOR EXPORT

The following support measures will be provided to organizations engaged in the production of medicines in accordance with GMP requirements for the export of domestic pharmaceutical products:

• subsidies covering up to 50% of transportation by motor road transport (not exceeding 5% of the export value of products) and by railway transport (not exceeding 7% of the export value of products) when exporting pharmaceutical products to all countries, excluding transportation costs for a period up to January 1, 2025;
• interest-free financial resources for commercial banks to finance revolving loans to replenish the working capital of domestic pharmaceutical exporting organizations when exporting goods with the condition of deferred payments. At the same time, loans issued at the expense of such resources are allocated for a period of no more than 1 (one) year at a rate of 4% per annum (taking into account the bank's margin) for the period of deferred payments and in the amount of the value of exported products in the equivalent of no more than USD 3 million.

ADDITIONAL MEASURES

According to Annexes Nos. 1 to 6 of the Decree, a number of additional measures have been taken aimed at the development of the pharmaceutical industry:

• The Decree has approved the list of forecast parameters for the development of the pharmaceutical industry for 2022-2026;
• The Decree has approved a targeted program providing for investment projects implemented in the pharmaceutical industry in the regions of Uzbekistan in 2022-2024. In particular, it was decided to expand the territory of the Tashkent Pharma Park scientific and production pharmaceutical cluster;
• The Decree has approved a list of investment projects in the pharmaceutical industry that require the development, coordination and approval of pre-project and project documentation in 2022-2026;
• The Decree has approved the composition of the Commission for the development of the pharmaceutical industry in Uzbekistan;
• The Decree has approved a roadmap that defines long-term preferential sources of financing for projects of domestic pharmaceutical organizations within the framework of the creation of production of biopharmaceutical medicines in the territory of Uzbekistan for 2022-2026;
• The Decree has also introduced a range of amendments to certain acts of the President of Uzbekistan.

The Decree entered into force on January 21, 2022. However, some of the amendments described above will enter into force on April 1, 2022, July 1, 2022 and January 1, 2023, respectively.

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