14 Mar 2022
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:
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:
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:
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:
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:
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:
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 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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