Dentons

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 essential medicines.

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 name).
    In other words, during this period priority in public procurement of medicines will be given to local producers of pharmaceuticals;

  • 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 Industry

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.

Certification

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.
 

Roadmap

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:

  1. 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 Samarkand);

  2.  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 Uzbekistan);

  3.  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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