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► Procedure for audit prior to issuance of license for pharmaceutical import takes force

The Procedure for Audit Prior to Issuance of a License to Perform Business Activity for Pharmaceutical Import, approved by Order of the Ministry of Health dated 27 February 2013 No. 168 (“the Procedure”), took force on 22 March 2013.

The Procedure defines the mechanism for auditing (i) the material and technical base, (ii) staff qualifications, and (iii) the terms for quality control of pharmaceuticals imported into Ukraine, required for performing business activity on import of pharmaceuticals.

Audit will take place not later than the sixth business day from the day when the business agent filed the application for a license to import pharmaceuticals, or a copy of one.

According to the Procedure the audit will last maximum three business days and will cover inter alia the following issues:
• the appropriate material and technical base;
• the presence of quality management system documents, in particular documents pertaining to standard operational procedures for pharmaceutical import;
• the presence of a staff schedule, of employee labor books and of documents confirming the relations between employees and the business agent (assignment orders, labor contracts, etc.); the audit will also make sure that the latter are duly formalized.
• etc.

As a side comment it is worth noting the practical issues associated with pharmaceuticals import into Ukraine before receipt of the relevant license. The State Customs Service of Ukraine clarified in its letter No.11.1/3-16.3/1961-ЕП dated 28 February 2013 that the law does not mention that customs clearance of pharmaceuticals should be supported with the relevant import license and, therefore, “there are no legal grounds for customs authorities’ checking the availability of this license upon customs clearance of pharmaceuticals.”

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We will continue to monitor further developments and will be happy to discuss with you any issues related to this information.