Registration of medicinal products in Ukraine: examination cost increase

March, 27, 2018

The State Expert Center of the Ministry of Health of Ukraine has informed about increasing of the cost for the examination of documents on medicinal products submitted for the state registration (re-registration) as well as for the examination of variations introduced into the registration documents during the period of validity of the registration certificate and for the examination of the materials for the possibility of incorporating the medicinal product into the State Register of Medicinal Products. The increase of the costs will come into force since April 23, 2018.

These changes will be implemented in response to the recommendations of the Report concerning compliance of the State Registration Process of medicinal products in Ukraine with the EU legislation and standards developed within the framework of the project of the European Bank for Reconstruction and Development and on the basis of the experience of individual European countries in elaborating the costs of expert work and services.

Please note that the official rates for registration of medicinal products in Ukraine are available on the website of the State Expert Center of the Ministry of Health of Ukraine (in Ukrainian language only). If you have any questions do not hesitate to contact our specialists from the Regulatory Affairs Department.

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