In accordance with the Decree of the Cabinet of Ministers of the Republic of Uzbekistan of March 23, 2018 No. 213 new Regulations on the procedure of the State registration of medicinal products, APIs and medical devices have been published and have come into force.
According to said Regulations the time frame of conducting the procedure of registration of medicinal products and medical devices is reduced from 180 workdays to 120-155 days depending on type of the product and the time frame of conducting the procedure of registration of API is reduced from 180 workdays till 50 days. Also the structures of the registration dossiers on medicinal product, API and medical device are heavily modified.
The validity period of the Certificate about the state registration has not been changed and constitutes 5 years, after that it is necessary to renew it each time for the next 5 years.
You can find the updated detailed information on the requirements and time frames by the following links: Registration of medicinal products in Uzbekistan or Registration of pharmaceutical ingredients in Uzbekistan.
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