Ukraine Simplifies Registration of Medicines

On June 19, 2016, amendments to the Ukrainian Law On the Medicinal Products came into effect simplifying the process of medicine registration.

The amendments aim to facilitate the state registration process in general and in particular for medicinal products for which a marketing authorization has already been obtained in the U.S., Switzerland, Japan, Australia, or Canada, or which have been registered under the centralized procedure in the European Union.

Previously, medicinal products authorized in these countries could get a marketing authorization under the simplified procedure only if they were intended for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncological and orphan diseases. Now the simplified procedure applies to all medicinal products.

Under the amendments, there is no need to file results from pre-clinical and clinical trials. No examination of registration dossiers is required during the authorization procedure, and the time period for making a final decision of the Ministry of Health on authorization has been reduced to seven business days.

Moreover, the registrants previously had to file a copy of a certificate confirming that the manufacturing practice meets the requirements of the Ukrainian legislation, but now, instead of this document, they may opt to file a written confirmation that they make products for the Ukrainian market in the same manufacturing facilities where they make products for the markets of the above-mentioned countries.

In terms of the medicinal products in general, under the amendments information on filed applications, such as their status and relevant decisions, should be available to the public online free of charge. Moreover, the State Register of Medicinal Products will include additional fields for data on prior authorizations as well as renewals and cancellations of authorizations.

By: Yuriy Karlash

For more information, please contact Yuriy Karlash at our Ukraine office.