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► Draft license provisions and drafts of other legal acts regarding licensing pharmaceutical import are presented for public discussion

Draft orders of the Ministry of Health of Ukraine (Ministry) on pharmaceutical import licensing have been published for public comment on the Ministry’s official website:
► Draft Order of the Ministry on Approval of the License Provisions on Performance of Business Activity on Import of Pharmaceuticals (hereafter - the License Provisions);
► Draft Order of the Ministry on Approval of the Procedure on Audit Prior to Issuance of License to Perform Business Activity for Import of Pharmaceuticals (hereafter - the Procedure on Audit);
► Draft Order of the Ministry on Approval of the Procedure on Control over Compliance with License Provisions on Performance of Business Activity for Import of Pharmaceuticals (hereafter - the Procedure on Control over Compliance with License Provisions).

If the drafts are approved, they will become effective on the date they are officially published.

Below we provide a brief summary of some provisions established by these drafts. Note that the list of provisions is not exhaustive and is based on the text of draft orders as presented on the Ministry’s official website as of today.

License Provisions on Performance of Business Activity on Import of Pharmaceuticals

The License Requirements establish qualification, organizational, technological and other requirements for performing business activity related to pharmaceutical import. According to the License Requirements, import is defined as any activity related to importation of pharmaceuticals into the territory of Ukraine, including but not limited to storage, quality control, series release and distribution of the pharmaceuticals.