PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of January 23, 2024 No. UP-20

About additional measures for regulation of pharmaceutical industry

In recent years in the republic complex measures for enhancement of circulation of medicines, products of medical prescription and medical equipment are realized.

At the same time reforming of pharmaceutical industry, safety, enhancement of state registration of pharmaceutical products, streamlining of activities of drugstores is required.

For the purpose of further improvement of providing the population with medicines, products of medical prescription and medical equipment with the guaranteed quality, safety and efficiency, and also enhancement of processes of streamlining of turnover of pharmaceutical products:

1. Determine the Ministry of Health the state body responsible for providing the population with high-quality and safe pharmaceutical products, streamlining of circulation of medicines and products of medical prescription.

2. Determine that since July 1, 2024:

a) the organizations which are engaged in production, wholesale and retail sale of medicines and products of medical prescription are recognized the organizations responsible for providing the population with medicines and products of medical prescription with the guaranteed quality, safety and efficiency in relation to which special rules of implementation of the state control are established;

b) the system of pharmacological supervision directed to operational identification and timely response to the potential hazards connected using medicines, providing on the basis of requirements of international standards is created:

implementation of the "Proper Practice of Pharmacological Supervision — GVP" standard;

creation in the Ministry of Health of the electronic information system giving collection opportunity from all links of health care system and the analysis of data on side effects of medicines;

c) the control system of safety of medicines takes root by provision of permissions to their use in medical practice. At the same time the Ministry of Health on analysis results of pharmacological supervision creates the list of substances with high risk level of damnification to health of the person.

3. Agree with the offer of the Ministry of Health on reorganization of the State unitary enterprise "The Center Ought the Practician" under Agency on development of pharmaceutical industry in public institution.

4. Approve the Plan of measures for development of pharmaceutical industry and providing the population with high-quality medicines according to appendix No. 1.

5. Establish procedure according to which:

a) since July 1, 2024:

in the organizations which are engaged in production, wholesale and retail sale of medicines and products of medical prescription the procedure of supervision of observance of requirements of the licenses granted by it by the notification of authorized body (except for the control events held based on appeals of physical persons and legal entities) no more once a year takes root;

content developed for the purpose of advertizing of medicines and dietary supplements on teleradio channels is aired based on the conclusion issued by the Ministry of Health;

creation of new customs and free storage locations of medicines and products of medical prescription is performed without fail according to requirements "Proper practice of storage - GSP";

b) since January 1, 2026 storage of medicines on the customs and free warehouses which do not have the certificate of conformity to requirements "Proper practice of storage - GSP is forbidden";

c) processes of licensing of pharmaceutical activities will be organized is coordinated with the pharmaceutical inspections which are carried out on compliance to requirements Ought the practician (GhP).

6. To the Ministry of Health in three-months time:

provide the organization of pharmacological supervision of medicines on the basis of the international requirements and radical review of activities of pharmacological supervision;

approve the "Proper Practice of Pharmacological Supervision — GVP" standard;

together with the interested ministries and departments to make in the Cabinet of Ministers offers on the changes and amendments in acts of the legislation following from this Decree.

7. Make changes and additions to some acts of the President of the Republic of Uzbekistan and the Government of the Republic of Uzbekistan according to appendix No. 2.

8. Assign to the acting minister of health care A. A. Hudayarov the personal responsibility for the effective organization of execution of this Decree.

Discussion of course of execution of this Decree, implementation of coordination and the control of organization activity responsible for its execution to assign to the Prime Minister of the Republic of Uzbekistan A. N. Aripov.

Appendix №1

to the Presidential decree of the Republic of Uzbekistan of January 23, 2024 No. UP-20

The plan died on development of pharmaceutical industry and providing the population with high-quality medicines

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