RESOLUTION OF THE PRESIDENT OF THE REPUBLIC OF UZBEKISTAN

of October 26, 2022 No. PP-411

About additional measures for providing the population with high-quality medicines and products of medical appointment

For the purpose of increase in level of security of the population and the medical organizations with high-quality medicines and products of medical appointment, creation of conditions for implementation of efficient public control in the sphere, and also ensuring execution of the tasks determined within open dialogue of the President of the Republic of Uzbekistan with representatives of health sector who is carried out on March 18, 2022 on the subject "Reforms in Medicine — for Honour and Advantage of the Person":

1. Establish procedure according to which since January 1, 2023:

a) all new medicines, except the medicines determined in the list according to appendix No. 1:

undergo state registration on the basis of positive result of clinical trials. At the same time carrying out state registration of separate medicines without clinical trials is performed according to the procedure established by the Ministry of Health;

undergo state registration in the Republic of Uzbekistan after studying with departure to the place of compliance of conditions of production to requirements "Proper production practice - GMP";

b) are cancelled:

approval by the Ministry of Health of the list of the medicines issued without recipe. At the same time issue of medicines according to the recipe and without recipe is performed according to the procedure, established in instructions on their medical application;

carrying out state registration of medicinal substances (substances);

reclamation of standard samples in case of recognition of results of carrying out registration of medicines outside the Republic of Uzbekistan;

c) providing with medicines and products of medical appointment of patients in the public stationary medical institutions (further - hospitals) republican level financed by means of the State fund of medical insurance is performed through hospital. At the same time the procedure for permission in some cases of use in hospital of the medicines and products of medical appointment provided by patients is determined by the Ministry of Health.

2. Determine that:

a) providing with medicines and products of medical appointment of patients in hospital:

it is performed originally in hospitals of republican level during 2023 in pilot procedure;

purchased within the guaranteed packet of medical services and medicines at the expense of means which allocation is provided on expense budget of hospital, it is performed on free basis, in other cases - it is performed on paid basis at the prices credited in hospital. At the same time the price of the medicines which are purchased by hospital shall not exceed the established wholesale reference prices;

b) since July 1, 2023 certification of medicines without specifying of the reference price or with excess of the specified price is forbidden.

3. To the Ministry of Health till the end of 2022:

a) approve the list of the medicines and products of medical appointment which do not have the analogs registered in the Republic of Uzbekistan, application in medical practice and which input is allowed for a period of up to January 1, 2028 with condition of obligatory certification without carrying out state registration. At the same time these medicines and products of medical appointment are subject to exception of the list approved by the Ministry of Health within three months from the date of carrying out state registration of their analogs in the Republic of Uzbekistan;

b) considering purchase by hospital in full of medicines and the products of medical appointment required for treatment of patients to provide:

introduction in hospitals of position of the procurement expert of medicines and products of medical appointment;

forming of primary necessary reserve by hospitals at the expense of means of the Government budget and extrabudgetary funds;

c) provide placement and regular updating on official websites of hospitals of daily remaining balance and the prices of the medicines and products of medical appointment which were purchased at the expense of means of the Government budget and extrabudgetary funds by sources.

4. Resolve implementation of payments by hospitals for purchase of medicines and products of medical appointment also in the terms established for the 1st expense group of classification of budgets expenses of the budget system.

Provide to the Ministry of Finance prediscretion annually in parameters of the Government budget of the means necessary for continuous providing hospitals with medicines and products of medical appointment, according to reasonable calculations of the Ministry of Health.

5. Determine that for the purpose of implementation of public control in retail trade of medicines since May 1, 2023:

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