March 2013

Audit of Licensees before Issue of Import Licenses for Pharmaceuticals

On 22 March 2013 the Procedure for Audits Prior to Licensing of Pharmaceuticals' Import (the "Procedure") became effective. The Procedure was approved on 27 February 2013 by Order No.168 of the Ministry of Health (the "Ministry").

The Procedure is a step in implementing the Licensing Terms on Pharmaceuticals Import (the "Licensing Terms"). Under the Licensing Terms the license is issued provided that the applicant possesses appropriate material, technical facilities and qualified staff, and is able to exercise quality control of pharmaceuticals imported to Ukraine.

The Procedure is compulsory for the companies intending to obtain the license for pharmaceuticals import. Accordingly, the application for the license provides the legal basis for the audit.

If the State Inspectorate for Pharmaceuticals has no reasons to refuse consideration of the application on the merits (such as failure to provide all required documents with the application), it instructs its respective local agency to perform the audit or performs such audit itself within 3 business days after receiving the application. The audit must be performed by authorized state inspectors not later than the 6th business day after the application is received. The audit may not last more than 3 business days. During the audit the inspectors are entitled to (i) enter the premises/territory of the company; (ii) inspect with necessary documents; (iii) receive explanations to their questions in writing. A report has to be prepared at the end of audit.

For further information please contact partner Oleksandr Padalka
and associate Anna Chornomorets

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