Benefits granted to the pharmaceutical industry of Uzbekistan
Tashkent, Uzbekistan (UzDaily.com) -- Presidential Decree “On additional measures to accelerate the development of the pharmaceutical industry of the republic in 2022-2026” was signed.
In order to improve the provision of the population with high-quality, effective and safe pharmaceutical products, increase the volume of production in the pharmaceutical industry and increase the level of security of the domestic market, the following were approved:
Forecast parameters for the development of the pharmaceutical industry for 2022–2026;
A targeted program of investment projects in the pharmaceutical industry implemented in the regions in 2022-2024;
List of investment projects in the pharmaceutical industry requiring the development, approval and approval of pre-project and project documentation in 2022–2026;
Composition of the Commission for the Development of the Pharmaceutical Industry.
From 1 April 2022, a mechanism for guaranteed purchase of pharmaceutical products subject to localization within the scope of the state budget funds planned for allocation for their purchase is being introduced by concluding a contract for a period of three years.
At the same time, tenders for the conclusion of guaranteed purchase agreements are held within the list of international generic names of substances, medicines, medical devices and medical equipment that have not been previously produced in the republic and are subject to localization in the future.
The list of pharmaceutical products is posted on a special public procurement information portal, the websites of the Ministry of Health and the Agency for the Development of the Pharmaceutical Industry. Winners for the conclusion of guaranteed purchase contracts are determined by open tenders.
To support organizations producing pharmaceutical products, it has been established that:
from 1 April 2022, state registration of new pharmaceutical products manufactured by domestic manufacturing organizations is carried out for an unlimited period, previously issued registration certificates after their expiration are subject to exchange for unlimited certificates within 15 days without requiring additional documents;
From 1 July 2022, the procedure for mandatory certification of medicines manufactured by domestic manufacturing organizations with the Good Manufacturing Practice (GMP) certificate, as well as medical devices and medical equipment manufactured by domestic manufacturing organizations with the ISO: 13485 certificate, is cancelled.
To reduce restrictions in the pharmaceutical industry, the following are canceled:
a ban on the collection of donated blood and the production of pharmaceutical products based on it in private;
restriction on conducting clinical trials of drugs on healthy volunteers;
restriction on the production of medicines with the same composition by one manufacturer under different trade names in order to create conditions for the development of the production of pharmaceutical products based on international brands and the fullest exploitation of existing existing capacities.
In order to implement the requirements of good practices (GxP):
from 1 April 2022, new manufacturing enterprises, wholesale and retail organizations in the pharmaceutical industry are created in accordance with the requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP);
the deadlines for mandatory certification of pharmaceutical industry organizations for compliance with the requirements of good practices (GxP) are extended until 1 January 2024;
from 1 February 2022, 75% of the expenses of domestic manufacturing organizations for the registration of pharmaceutical products in foreign countries are covered from the Fund for Support and Development of the Pharmaceutical Industry after the submission of a document confirming its registration;
from 1 January 2023, only organizations that have organized the production of medicines - according to the standards of "Good Manufacturing Practice" (GMP), medical devices and medical equipment - according to the standards ISO: 13485, as well as organizations wholesalers that have implemented Good Distribution Practice (GDP) standards.
Until 1 January 2025, the following items not produced in Uzbekistan are exempted from customs duties:
technological and laboratory equipment;
components and spare parts for them;
sandwich panels and ventilation systems for pharmaceutical production facilities;
raw materials and supplies;
packaging materials used for keeping laboratory animals, preclinical studies, production of medicines, -
imported by manufacturers of pharmaceutical products, enterprises engaged in the wholesale sale of pharmaceutical products, specialized research institutes and higher educational institutions - for their own needs, 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.