Ukraine. Import of drugs to Ukraine: quality control

The state quality control is carried out by the State Drug Inspectorate with directly subordinated to it state drug inspectorate in the Autonomous Republic of Crimea, regions, Kyiv and Sevastopol pursuant to the Procedure for the state control over drugs imported into Ukraine as approved by the Resolution of the CMU dd. 14.09.2005 #902.

Drugs registered in Ukraine can be imported to Ukraine provided availability of a quality certificate issued by the manufacturer which confirms their compliance to the quality specifications. All drugs imported to the customs territory of Ukraine for purposes of their further sale or use in manufacturing officinal drugs, are subject to state quality control.

Within 3 business days after customs clearance of the drugs a business entity shall submit to the state control authority at the place of its business conduction an application on issue of a quality report on imported drug in the form approved by the State Drug Inspectorate. Additionally, the applicant shall submit a copy of its license, copies of the drug quality and registration certificates, a copy of the document confirming that the manufacturer has drug manufacturing license or a copy of the GMP certificate, a list of drugs to be imported, copies of the customs declaration and invoice as well as a sample of the original package. Information on submitted documents is subject to expert examination; the freight shall be inspected and, if necessary, is subject to laboratory analysis. The results of the control shall be stated in a report. If the report is positive, the circulation of imported drug is allowed in Ukraine.

During the state control a business entity is obliged to place the freight with the drugs in a special zone (premises) in the warehouse at the place of its business apart from other products, to make inscription «quarantine» and to provide duly conditions for its storage. Until receipt of a positive report the circulation of drugs in Ukraine is not allowed
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