From 01.03.2016, separate provisions of the Licensing conditions for conducting business activities on the import of medicinal products should enter into force (order of the Ministry of Health No. 143 of 20.02.2013).

Medicines importers were not ready for the changes. Therefore, in the draft resolution of the CMU “On the approval of the Licensing conditions for the implementation of economic activities for the production of medicinal products, wholesale and retail trade of medicinal products, import of medicinal products (except for active pharmaceutical ingredients)” there was a provision that certain items of Section 6 (Licensing of the import of medicinal products funds) shall enter into force on March 1, 2018.

On February 11, 2016, the draft of the License Terms was sent to the interested bodies and is currently being processed by the Ministry of Economic Development and Trade, the Ministry of Finance, and the State Regulatory Service. On February 22, 2016, the Antimonopoly Committee approved the draft License Terms with comments. After receiving approvals from the specified bodies, the project will be sent to the Ministry of Justice.

The entry into force of the new provisions of the Licensing conditions for conducting economic activity on the import of medicinal products from 01.03.2016 does not affect the procedure for importing medicinal products into Ukraine, as well as the procedure for state quality control of medicinal products imported into Ukraine (implementation of the Resolution of the CMU dated 14.09. 2005 No. 902 “On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine”).

At the same time, during license inspections of importers and making decisions based on their results, the State Medical Service will take into account the prospect of postponing the relevant requirements for the activities of the specified licensees.

Published based on the materials of diklz.gov.ua