Recent Developments

On 15 January 2015, theParliament of Ukraine adopted Law of Ukraine No.126-VIII "On amendments toseveral Laws of Ukraine regarding abolishing import licensing of activepharmaceutical ingredients (the "Amendment"). This Amendmentabolishes the requirement to obtain a license to import active pharmaceuticalingredients ("APIs"), which became effective from 1 January 2015.

Import licensing ofpharmaceuticals was introduced by Law of Ukraine No. 5038-VI "Onamendments to several Laws of Ukraine regarding import licensing ofpharmaceuticals and regarding the definition of the Term "ActivePharmaceutical Ingredient" dated 4 July 2012 (the "Import LicensingLaw"). Pursuant to the Import Licensing Law, an import license for pharmaceuticalsinto Ukraine has been required since 1 March 2013, while the import of APIs wasexempt from the licensing requirement until 1 January 2015.   

TheAmendment was published on 31 January 2015 and it became effective on 1February 2015. As a result, importers may continue to import APIs to Ukrainewithout obtaining an import license.

Conclusion

The Amendment should improve the framework of legal regulation in the field ofcirculating pharmaceuticals and create favorable conditions forentrepreneurship in the Ukrainian pharmaceuticals market.

Additional notes

ThisLEGAL ALERT is issued to inform Baker & McKenzie clients and otherinterested parties of legal developments that may affect or otherwise be ofinterest to them. The comments above do not constitute legal or other adviceand should not be regarded as a substitute for specific advice in individualcases.