Contents
► Review of legislation that takes force in 2013

This newsletter briefly reviews certain legislation regulating the pharmaceutical sector that was approved in 2012 and takes force in 2013.

Pharmaceutical import licensing developments The Law of Ukraine “On the Introduction of Changes to Certain Legislative Acts of Ukraine on Licensing Activity for Import Pharmaceuticals and Defining ‘Active Pharmaceutical Ingredient’” No.5038-VI dated 4 July 2012 (hereinafter – the Law) foresees introduction of a pharmaceutical import licensing regime. According to the Law the regime shall take force on 1 March 2013. Starting then, import of registered pharmaceuticals into the customs territory of Ukraine must be supported with an import license issued to the importer and by a quality certificate issued by the manufacturer.

An attachment to the import license should list the pharmaceuticals that the licensee has accepted for import and the special terms according to which the activity is to be conducted. To obtain the license the importer must have the relevant material and technical base, a qualified staff and the conditions necessary to ensure quality control of pharmaceuticals imported into Ukraine. The licensing state authority will audit compliance of these criteria with the law.

As of today, a sufficient legislative base on obtaining the license’s has not been yet developed. Given this, the issues connected with the pharmaceutical import licensing regime are still opened for discussions. It cannot be ruled out that introduction of the pharmaceutical import licensing regime could be postponed. We are aware on proposals to postpone this regime to 1 September 2013.