PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of June 20, 2018 No. UP-5460

About measures for increase in efficiency of state registration of medicines and improvement of providing

Number of the measures directed to forming of new health care system and management of pharmaceutical industry is in recent years accepted. Providing the population of the country with high-quality medicines and products of medical appointment is one of the main directions of development of health care system of the Republic of Uzbekistan.

At the same time still there are unresolved certain problems interfering realization of the undertaken reforms, improvement of quality of the provided medical care and indicators of health of the population.

In particular, there is excessively difficult system of state registration of the medicines including made in the countries with high requirements to their production and application that leads to import of inefficient medicines.

Creation in the country of wide network of social drugstores, and also need of enhancement of mechanisms of public procurements and establishment of the transparent competition in the pharmaceutical market requires review of procedure for realization of socially important medicines and products of medical appointment on fixed prices.

For the purpose of improvement of conditions for development of pharmaceutical industry, further increase in availability of high-quality medicines and growth of investment appeal of the pharmaceutical market of Uzbekistan:

1. Approve offers of the Ministry of Health and the National agency of project management in case of the President of the Republic of Uzbekistan:

about cancellation of the requirement about realization for fixed prices of socially important medicines and products of medical appointment;

about implementation since August 1, 2018 of procedure for recognition of results of the state registration of medicines, including medicinal substances (substances) and medicines (further - medicines) performed in the countries with high regulatory requirements.

2. Determine that:

a) ceased to be valid according to the Presidential decree of the Republic of Uzbekistan of 29.12.2023 No. UP-221

b) recognition of results of registration of the medicines registered in the countries with high regulatory requirements is performed:

based on differentiation of authorized bodies of the foreign states and the international organizations responsible for state registration of the medicines which are not raising doubts on safety, quality and efficiency;

on condition of availability of permission to use of medicines which results of state registration are recognized the Republic of Uzbekistan, medical practice of the countries with high regulatory requirements;

c) medicines to which the procedure provided by the paragraph third Item 1 of this Decree is applied do not pass the examination in case of state registration in the territory of the Republic of Uzbekistan for the purpose of establishment of safety, quality and efficiency of these means.

3. Declare invalid Item 11 of the Presidential decree of the Republic of Uzbekistan of November 7, 2017 No. UP-5229 "About Measures for Cardinal Enhancement of Management System Pharmaceutical Industry".

4. To the Ministry of Health of the Republic of Uzbekistan:

a) on the basis of studying of the advanced international practice to provide review of standards of diagnostics, treatment and clinical protocols of the main diseases and quarterly review of the List of socially important medicines and products of medical appointment in a month;

b) together with the National agency of project management in case of the President of the Republic of Uzbekistan till July 20, 2018 critically to study and make offers on:

to establishment of procedure for recognition of results of the state registration of medicines performed in the countries with high regulatory requirements;

to enhancement of requirements to customs clearance, state registration and realization of medicines, and also on other questions regulating pharmaceutical activities;

c) together with the Prosecutor General's Office and the National agency of project management in case of the President of the Republic of Uzbekistan till December 1, 2018 to carry out inventory count of the medicines registered in the country regarding prohibition availability to application in the countries with high regulatory requirements, studying of the reasons and conditions of introduction of such prohibitions and to make offers on feasibility of their further application in the territory of the Republic of Uzbekistan.

5. To the national agency of project management in case of the President of the Republic of Uzbekistan till July 20, 2018 to bring:

on approval the list of the countries and the international organizations which results of state registration of medicines are recognized the Republic of Uzbekistan;

offers on the changes and amendments in the legislation following from this Decree.

6. To impose control of execution of this Decree on the Prime Minister of the Republic of Uzbekistan A. N. Aripov, the director of the National agency of project management in case of the President of the Republic of Uzbekistan Sh. M. Sadikov, the Attorney-General of the Republic of Uzbekistan O. B. Murodov and the Minister of Health of the Republic of Uzbekistan A. K. Shadmanov.

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