Uzbekistan

The population of Uzbekistan is about 33 million people. The country is characterized by a powerful mineral resource base, that plays a significant role in the country’s economy. Uzbekistan is a country with one of the fastest-growing economies in the world.

The official language of Uzbekistan is Uzbek. Russian is spoken by 50-80% of the population in Uzbekistan. The Russian language is compulsory for study in all universities of the country and is also the main language of office work in large cities.

The health expenditure is more than 15% of the country’s budget. The volume of the Uzbek pharmaceutical market is more than $1.3 billion, and the market for medical devices and devices for in-vitro diagnostics is about $400 million. Import plays a very important role and accounts for about 80% of the pharmaceutical and medical market.

Import and sale of medicinal products are allowed only after state registration. To import medical devices and medical equipment, it is also necessary to obtain a Marketing Authorization. Import and production of special food products, perfumes and cosmetics is carried out with the permission of the authorized body.

 

Competent authorities:

Ministry of Health of the Republic of Uzbekistan
Central executive authority in healthcare
Web site: http://www.minzdrav.uz/ 

State Unitary Enterprise “State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment” of the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan
Competent authority performing expert work for the registration of medicinal products and medical devices
Web site: http://www.uzpharm-control.uz/ 

General Directorate of Sanitary and Epidemiological Surveillance of the Ministry of Health of the Republic of Uzbekistan (GUSEN)
The competent authority responsible for sanitary and epidemiological welfare, conducting the necessary studies and trials

 

The main legislative acts:

  1. Decree of the President of the Republic of Uzbekistan No. PP-3948 dated September 24, 2018 “On additional measures to improve the procedure for state registration and circulation of medicinal products”.
  2. The Law of Uzbekistan “On Medicines and Pharmaceutical Activity” as amended according to the Law of the Republic of Uzbekistan No. ЗRU-399 dated January 4, 2016.
  3. Decree of the Cabinet of Ministers No. 213 dated March 23, 2018 “Regulation on the procedure for state registration of medicines, medical devices and medical equipment and the issuance of a marketing authorization”.
  4. Resolution of the Cabinet of Ministers No. 862 dated October 25, 2018 “On approval of the regulation on the procedure for recognition of the results of registration of medicines carried out outside the Republic of Uzbekistan”.
  5. Resolution of the Cabinet of Ministers No. 131 dated April 30, 2016 “On approval of the provisions on the procedure for licensing procedures in the system of sanitary and epidemiological service of the Republic of Uzbekistan”.
  6. Order of the Ministry of Health of the Republic of Uzbekistan 2018 No. 3000 dated April 16 “On approval of the regulation on the procedure for informing identified adverse reactions when using medicinal products”.
  7. Order of the Ministry of Health of the Republic of Uzbekistan No. 2846 dated November 6, 2016 “On approval of the list of mandatory medicinal products and medical devices for all pharmacies”.
  8. Order of the Ministry of Health of the Republic of Uzbekistan No. 442 dated December 27, 2013 “On advertising of medicinal products intended for medical institutions and medical workers of the Ministry of Health and control over the implementation.”

 

Cratia provides professional services of state registration of medical (healthcare) products in Uzbekistan. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:

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(name, formulation, dose and route(s) of administration, date of therapy start)