Ukraine. Drug sale in Ukraine: licensing in wholesale

Pursuant to par. 9 Article 9 of the Law of Ukraine «On Licensing of Certain Economic Activity Types» dd. 01.06.2000 #1775-3, Article 19 of the Law of Ukraine «On Medicinal Products» dd. 04.04.1996 #123/96-VR medicinal product wholesale can be exercised by legal entities and individuals – private entrepreneurs having respective license. Detailed description of the procedure and conditions for license obtaining is contained in the Licensing conditions for medicinal product manufacturing, wholesale and retail approved by the joint decree of the State Committee of Ukraine on Regulatory Policy and Entrepreneurship and the State Drug Inspectorate dd. 03.03.2009 #44/27.

The wholesale license is issued based on an application submitted personally or through an authorized person and documents provided in the Licensing conditions. The State Drug Inspectorate shall decide on issue or refusal in issue of license within 10 business days as of receipt of the license application and attached documents.

If there are any reasons for re-execution of the license (change of legal entity's or private entrepreneur’s name, change of address etc) the licensee is obliged to submit a license re-execution application and respective documents to the State Drug Inspectorate within 10 business days.
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