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The pharmaceutical industry of Uzbekistan is undergoing
structural and regulatory changes. During the last two years,
Uzbekistan has undertaken various measures in this field including
establishing free economic zones for pharmaceutical companies,
organizing social pharmacies and adopting the updated list of
On April 10, 2019, the President of the Republic of Uzbekistan
signed Decree No. UP-5707 "On further measures for accelerated
development of the pharmaceutical industry of the republic in
2019-2021" (UP-5707) that introduces a number of actions to
improve the pharmaceutical sector of the country.
In particular, the Decree provides for the following:
Support of local producers
UP-5707 contains a range of measures to encourage import
substitution and the development of local production of medicines
and to support local producers of pharmaceuticals:UP-5707 contains
a range of measures to encourage import substitution and the
development of local production of medicines and to support local
producers of pharmaceuticals:
- As an experiment, during the period from July 1, 2019 to
December 31, 2020, in the public procurement process, all
applications for the supply of import medicines will be rejected if
there are two or more local participants that produce similar
products (according to the international non-proprietary
In other words, during this period priority in public procurement
of medicines will be given to local producers of
- Provision of collaterals for commercial bank loans by the State
Fund for Support of Entrepreneurship Development under the Cabinet
of Ministers of Uzbekistan to local producers of medicines and
medical products in the amount of up to 50% of the loan but not
more than 10 billion UZS;
- Reimbursement of 50% of local producers' expenses for
registration of pharmaceutical products in foreign countries;
- Extension of the state registration and re-registration of
medicines manufactured on the basis of "in bulk" products
(any unmarked and unpackaged medicine or medical product produced
outside of Uzbekistan) is possible only in the absence of similar
local products in amounts sufficient for the domestic market.
Agency for Development of Pharmaceutical
The Agency for the Development of the Pharmaceutical Industry
(Agency) was established in 2017 as a special body under the
Ministry of Health of Uzbekistan authorized to promote the
country's pharmaceutical industry.
Changes introduced by UP-5707:
- Transfer of responsibilities for supervision over production,
manufacturing and wholesale of medicines and medical products as
well as licensing of pharmaceutical industry from the Ministry of
Health to the Agency (licenses previously issued by the Ministry
are valid until their expiration date);
- Establishment of the Fund for Support and Development of
Pharmaceutical Industry (Fund) under the Agency.
Assets of the Fund are to be formed from customs fees for imported
medicines and medical products, resources allocated by the Fund for
Reconstruction and Development of Uzbekistan, grants of
international financial institutions and other sources.
The Fund's resources will be used for providing equipment to
research institutes and state laboratories, covering expenses of
local pharmaceutical producers for pre-clinical and clinical
research and other purposes.
By January 1, 2022:
- All laboratories for pre-clinical research of pharmaceuticals
are subject to compulsory certification for compliance with
national Good Laboratory Practice (GLP) requirements;
- All clinical sites of the Ministry of Health for clinical
research are subject to compulsory certification for compliance
with national Good Clinical Practice (GCP) requirements;
- All local medicine producers are subject to compulsory
certification for compliance with national Good Manufacturing
Practice (GMP) requirements;
- All enterprises engaged in wholesale of pharmaceuticals are
subject to compulsory certification for compliance with national
Good Distribution Practice (GDP) requirements.
Localization of production
|UP-5707 adopted the List of medicines recommended for local
production in Uzbekistan during 2019-2021, which contains 10 groups
of medicines including antibiotics, antiviral medicines,
immunobiological medicines and other pharmaceuticals.
UP-5707 also adopted the Roadmap for accelerated development of
the pharmaceutical industry of the republic for 2019-2021. The
Roadmap provides for implementation of the following measures:
- Measures to improve material and technical basis of the Agency
for Development of Pharmaceutical Industry (e.g.reconstruction of
the Agency's premises, allocation of a building for
"Oriental Medicine" research institute in
- Measures to implement international standards in the
pharmaceutical industry and healthcare system (e.g. enhancing
cooperation between the Agency and "Pharmaceutical Inspection
Co-operation Scheme" and other relevant organizations,
developing and approving the State Pharmacopoeia of
- Measures to improve effectiveness of the government
regulation and support of the pharmaceutical industry (e.g.
approving Regulations of the Fund for Support and Development of
Pharmaceutical Industry, developing and approving the Concept for
the development of the pharmaceutical industry for 2020-2024).
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