Uzbekistan admits drug registration from countries with high regulatory requirements

| By | Drug Registration, Medicinal Drug Prices, Uzbekistan

On 20.06.2018, the President of Uzbekistan signed a decree “On measures to improve the efficiency of state registration of medicines and their provision to the public.” This document invalidated the requirement for selling socially important medicinal products and medical devices at fixed prices.

From 1.08.2018, Uzbekistan will recognize the results of state registration of medicines, including medicinal substances and drugs, in the countries with high regulatory requirements.

Recognition will be carried out:

  • by identifying the authorities of foreign states and international organizations responsible for the state registration of medicines, that raise no doubts in terms safety, quality and efficacy;
  • subject to the permit for the use of medicines, the results of state registration of which are recognized in the Republic of Uzbekistan, in the medical practice of countries with high regulatory requirements.

Such medicines will not be submitted for expert examination during their state registration in Uzbekistan to establish safety, quality, and efficacy of these products.

By 1.12.2018, together with the Prosecutor General’s Office and National Agency for Project Management under the President of Uzbekistan, the Ministry of Health will take the inventory of medicines registered in Uzbekistan in terms of their prohibition for use in the countries with high regulatory requirements, examine the reasons and conditions for such prohibitions, and make proposals on the appropriateness of their further use in Uzbekistan.