MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

Simplified registration of medicinal products and APIs in Uzbekistan




December 21, 2018

In accordance with the Resolution of the President of the Republic of Uzbekistan new Decree of the Cabinet of Ministers of the Republic of Uzbekistan of October 24, 2018 No. 862 has been published and has come into force. Referring to said legislative acts medicinal products and APIs that have been registered in country, wherein regulatory authorities apply high quality standards, particularly of EU Member States, Switzerland, UK, USA, Canada, Japan, Australia, South Korea, may be allowed for use in Uzbekistan after conducting the simplified procedure of recognition of the state registration.

The time frame of conducting the procedure of recognition of the state registration of a medicinal product or API constitutes not more than 15 working days after receipt of the payment for the examination of documents and samples by the State Centre of Expertise and Standardization of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health of the Republic of Uzbekistan.

The validity of the conclusion on recognition of the state registration of a medicinal product or API in Uzbekistan will constitute 5 years and after that it is possible to renew it for unlimited period.

You can find the updated detailed information on the requirements and time frames by the following links:

State registration of medicinal products in Uzbekistan

State registration of APIs in Uzbekistan

In order we could provide you with the detailed information on the associated costs as well as the exact list of required documents and the Power of Attorney form for execution, etc. please contact our specialists from Regulatory Affairs Department.


simple counter
Subscribe to our Newsletter