On 15 January 2015, the Parliament of Ukraine adopted Law of Ukraine No.126-VIII "On amendments to several Laws of Ukraine regarding abolishing import licensing of active pharmaceutical ingredients (the "Amendment"). This Amendment abolishes the requirement to obtain a license to import active pharmaceutical ingredients ("APIs"), which became effective from 1 January 2015.
Import licensing of pharmaceuticals was introduced by Law of Ukraine No. 5038-VI "On amendments to several Laws of Ukraine regarding import licensing of pharmaceuticals and regarding the definition of the Term "Active Pharmaceutical Ingredient" dated 4 July 2012 (the "Import Licensing Law"). Pursuant to the Import Licensing Law, an import license for pharmaceuticals into Ukraine has been required since 1 March 2013, while the import of APIs was exempt from the licensing requirement until 1 January 2015.
The Amendment was published on 31 January 2015 and it became effective on 1 February 2015. As a result, importers may continue to import APIs to Ukraine without obtaining an import license.
The Amendment should improve the framework of legal regulation in the field of circulating pharmaceuticals and create favorable conditions for entrepreneurship in the Ukrainian pharmaceuticals market.