of December 30, 2019 No. PP-4554
About additional measures for deepening of reforms in pharmaceutical industry of the Republic of Uzbekistan
Complex measures for improvement of system of drug circulation, products of medical appointment and medical equipment are in recent years realized (further - pharmaceutical products), favorable conditions for development of domestic pharmaceutical industry are created.
At the same time the domestic pharmaceutical industry does not satisfy adequately the need of the population and treatment and prevention facilities for pharmaceutical products.
In particular, the pharmaceutical industry lags behind similar industry of economically developed countries according to the product range. So, the share of domestic medicines in the domestic market constitutes 27 percent in cost and 45 percent in kind.
Unreasonable increase in prices for medicines in the Republic of Uzbekistan in comparison with the border countries is also promoted by lack of the transparent and effective mechanisms of pricing which are successfully used in the developed states of the world.
For the purpose of further improvement of providing the population with high-quality, effective and safe pharmaceutical products, expansion of production volumes, growth of the scientific and technical and export potential of domestic manufacturers, and also attraction of direct foreign investments:
1. Establish procedure according to which:
a) since July 1, 2020 the system of reference pricing on medicines of national and foreign production providing step by step takes root:
the choice at least 10 reference countries relating to group of the countries high above average or below average incomes per capita;
representation to registering body by the holder of the registration certificate or its authorized representative of selling price of the producer in country of source, the reference countries and the Republic of Uzbekistan of medicine of the same producer with the same active agent taking into account dosage form, quantity of units in packaging, dosages, concentration, amount and packing;
ceiling registration of prices for each trade name of medicine taking into account dosage form, quantity of units in packaging, dosages, concentration, amount and packing above which its delivery to the Republic of Uzbekistan (for import medicines) and leave by domestic manufacturer cannot be performed (for domestic medicines);
b) The agency on development of pharmaceutical industry under the Ministry of Health of the Republic of Uzbekistan (further - the Agency) is the authorized body responsible for:
monitoring and the analysis of system of reference pricing on the trade name of medicine, including with involvement of bodies and organizations for consumer protection and the public;
ceiling registration of prices for each trade name of medicine above which their delivery to the Republic of Uzbekistan (for import medicines) and leave by domestic manufacturer cannot be performed (for domestic medicines);
creation and maintaining on the official website on the Internet of the automated information system containing data on the organizations performing pharmaceutical activities, registered and the certified pharmaceutical products, and also the registered ceiling prices for the trade name of medicine and marginal wholesale and retail prices taking into account the established limiting trade allowances;
c) since July 1, 2020 in all medical organizations of the republic, irrespective of pattern of ownership, the obligatory procedure for the statement of recipes only according to the international non-proprietary name of medicines takes root.
Monthly to the 5th to provide to the State Customs Committee representation to the Agency of detailed data on the imported pharmaceutical products (the importer, description of goods, amount, the price and others) for the subsequent monthly publication on the website of the Agency.
a) The concept of development of pharmaceutical industry of the Republic of Uzbekistan in 2020 - 2024 (further - the Concept) according to appendix No. 1, providing:
extension of the nomenclature of the pharmaceutical products made taking into account the best scientific practices and modern technologies and also development of pharmaceutical industry by stimulation of development and production of innovative pharmaceutical products, commissioning of modern productions, and also upgrades and strengthenings of material and technical resources of the existing productions;
development of domestic pharmaceutical industry by ensuring compliance of the organizations and companies to requirements of the standards harmonized with the international requirements for development and production of pharmaceutical products;
investment attraction and advanced technologies, including the foreign pharmaceutical companies, to creation of modern competitive productions on release of pharmaceutical products;
implementation of localization and production organization of substances on the basis of medicinal vegetable raw materials for the subsequent production of medicines from them;
decrease in import of pharmaceutical products due to upgrade, increases in the operating production capacities and development of new types of pharmaceutical products, and also by investment attraction;
step-by-step implementation on the domestic enterprises of requirements of proper production practice (GMP) and proper practice of pharmakonadzor (GVP), and also the practician directed to regulation of quality management system and safety in case of distribution (GDP), carrying out preclinical (GLP) and clinical testing (GCP);
enhancement of mechanisms of pricing, implementation of systems of marking and tracing of pharmaceutical products;
strengthening of capacity of national regulatory authority by enhancement of the legislation in the field of development, production and quality control of pharmaceutical products according to modern international requirements;
ensuring preparation, retraining and advanced training of personnel for pharmaceutical industry of the republic on the basis of the best foreign practices, including in such important directions, as biotechnology of medicines, chemical technology of medicinal substances, technology of finished pharmaceutical products and phytomedicines, management and economy of pharmacy, pharmaceutical chemistry and microbiology;
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