Medicinal products and APIs in Ukraine: changes in renewal terms

In accordance with the Decree of the Cabinet of Ministers of Ukraine of March 27, 2019 No. 296 new amendments to the terms of submission of applications for renewal of registration of medicinal products and APIs in Ukraine were published and came into force on April 9, 2019.

Pursuant to said amendments the deadline for submission of applications for renewal of registration of medicinal products and APIs in Ukraine is changed from 90 days to 180 days before expiration of previous registration.

The detailed information on the requirements and time frames for registration of medicinal products and APIs in Ukraine is available on the following links:

If you need more information on the associated costs and the exact list of required documents as well as sample of the Power of Attorney for execution, etc. please contact our specialists from Regulatory Affairs Department.