RESOLUTION OF THE PRESIDENT OF THE REPUBLIC OF UZBEKISTAN

of September 24, 2018 No. PP-3948

About additional measures for enhancement of procedure for state registration and circulation of medicines

In pursuance of the 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 the Population with Them":

1. Approve the List of the countries, the international and foreign organizations which results of registration of medicines are recognized the Republic of Uzbekistan, according to appendix.

2. Establish procedure according to which since November 1, 2018:

the requirement about issue of the registration certificate (its duplicate) of medicine by issue at the request of the applicant of the statement from the State register of medicines, products of medical prescription and medical equipment is cancelled (further - the State register);

state bodies and the organizations when rendering the state services independently receive the statement about state registration of medicines from the State register in electronic form;

results of state registration of medicines join in the form of record in the State register without restriction of effective period after the term of their first state registration;

drugstores and their branches have the right to sell "angro" the products which are packed up, packed and marked in pharmaceutical conditions with use of the special equipment according to the procedure, established by the Ministry of Health of the Republic of Uzbekistan;

to medical institutions, including state, acquisition "angro" is allowed to products with observance of procedure for storage and leave of medicines.

3. Determine that "angro" products the medicine made and realized in large packing, and also used for further production (production) of finished pharmaceutical products is recognized.

4. To the Cabinet of Ministers of the Republic of Uzbekistan in decade time to approve Regulations on procedure for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan.

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

till November 1, 2018 to provide placement of information on state registration of medicines on the official website of the State center of examination and standardization of medicines, products of medical prescription and medical equipment of the Agency on development of pharmaceutical industry under the Ministry of Health of the Republic of Uzbekistan;

till November 1, 2018 to develop and approve the procedure for realization by drugstores and their angro branches of products providing requirements to availability of the special equipment on packing, packaging and marking "angro" products in pharmaceutical conditions, and also qualification of persons performing their packing, packaging, marking and realization;

till April 1, 2019 together with the Center for accreditation under the Uzbek agency of standardization, metrology and certification to develop and implement the Unified information system of monitoring of the issued certificates of conformity on medicines, products of medical prescription and medical equipment;

in two-month time together with the Ministry of Justice and other interested departments to make in the Cabinet of Ministers of the Republic of Uzbekistan offers on the changes and amendments in the legislation following from this resolution.

6. Add the List of economic societies and companies of strategic importance for which the separate procedure for purchases of goods (works, services) approved by the resolution of the President of the Republic of Uzbekistan of January 22, 2018 No. PP-3487, Item 19 of the following content is established:

"19. JSC Dori-Darmon.

7. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan A. A. Abdukhakimov and the first deputy adviser to the President of the Republic of Uzbekistan B. M. Mavlonov.

Appendix

to the Resolution of the President of the Republic of Uzbekistan of September 24, 2018 No. PP-3948

The list of the countries, the international and foreign organizations which results of registration of medicines are recognized the Republic of Uzbekistan

I. Countries

1. Australian Union

2. Kingdom of Belgium

3. United Kingdom of Great Britain and Northern Ireland

4. Germany

5. Kingdom of Denmark

6. Israel

7. Ireland

8. Kingdom of Spain

9. Italy

10. Canada

11. South Korea

12. Kingdom of the Netherlands

13. Kingdom of Norway

14. Slovenia

15. United States of America

16. Finland

17. France

18. Swiss Confederation

19. Kingdom of Sweden

20. Japan

21. Hungary

II. International and foreign organizations

1. European agency of medicines (EMA), European Union.

2. Management on quality control of foodstuff and medicines (FDA), the USA.

3. The agency on pharmaceutics and the medical equipment (PMDA), Japan.

4. Ministry of safety of foodstuff and medicines (MFDS), Republic of Korea.

5. Agency on control of medicines and products of medical prescription (MHRA), Great Britain

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