Uzbekistan Simplifies Approval of Medicines Registered in 20 Other Countries

Uzbekistan’s president signed a decree on June 22, 2018 abolishing the requirement to examine the safety, quality and effectiveness of medicines authorized in countries with high regulatory requirements. Previously, no medicines registered abroad were eligible for marketing authorizations under the simplified procedure in Uzbekistan. The 20 countries, determined by another presidential decree dated September 24, 2018, are the following:

• Australia;
• Belgium;
• UK;
• Germany;
• Denmark;
• Israel;
• Ireland;
• Spain;
• Italy;
• Canada;
• South Korea;
• Netherlands;
• Norway;
• Slovenia;
• USA;
• Finland;
• France;
• Switzerland;
• Sweden; and
• Japan.

Uzbekistan will also apply the simplified procedure to medicines registered by the European Medicines Agency (EMA), an EU agency for the evaluation of medicinal products.

The simplified procedure was established by the Resolution of the Cabinet of Ministers No. 862, dated October 24, 2018. The competent authority is the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment under the Ministry of Health.

The following are eligible for accelerated approval:

• medicines authorized in one of the countries with high regulatory requirements;
• new combinations of medicines already authorized in Uzbekistan; and
• medicines already authorized in Uzbekistan but produced in new forms, dosages or packages, with a different label or by other manufacturers.

Under the simplified procedure, once the applicant submits the required documents and pays the EUR 1,082 (USD 1,237) application fee, the State Center has 15 working days to reach the decision on granting a marketing authorization and one working day to notify the applicant. Approved medicines are recorded into the State Register of Medicines, Medical Devices and Medical Equipment and are initially valid for a period of five years. After this period, the holder can apply for renewal and after the renewal, the marketing authorization will remain valid for an unlimited period.

An application may be refused if it contains incomplete or invalid information, but applicants can re-apply within 15 working days upon receipt of a notification of refusal.

The authorization can be terminated if:

• the medicinal product is banned in Uzbekistan or in the country where it was originally authorized;
• the medication causes serious side effects not specified in the instructions for use; or
• the applicant requests termination.

By: Djakhangir Aripov

For more information, please contact Djakhangir Aripov at our Uzbekistan office.