Import Licensing Introduced

On 04.07.2012 Verkhovna Rada of Ukraine adopted the Law #538-VI "On amending certain laws of Ukraine (as regarding licensing of drugs import and definition of the term "active pharmaceutical agent" (further referred to as law). This law made amendments to the Law of Ukraine "On licensing of certain kinds of economic activity" and supplemented it with the provision that the activity on import of drugs in Ukraine is also subject to licensing as well as other kinds of activity.

For the purposes of implementing the provisions of the law on imported medicines licensing relevant license conditions will be developed.

To ensure compliance with European legislation importer of medicines, which plans to import drugs into Ukraine, must have an authorized representative or other legal entity, which would be fully administratively and criminally liable in accordance with national law for the quality, safety and efficiency of an imported drug.