Pharmaceutical sector
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► License Provisions on Performance of Business Activity forImport of Pharmaceuticals are approved

Ministry of Health (Ministry) order No. 143 of 20 February 2013 has approved the License Provisions on Performance of Business Activityfor Import of Pharmaceuticals (hereinafter – the License Provisions).

The approved License Provisions provide for less stringent requirements for pharmaceutical import licensing than did the original draft of the law (which was published on the Ministry’s official websitefor public comment and which we discussed in our 17 January 2013

Newsletter). The Provisions envisage the following novelties:

1) The import of pharmaceuticals requires a license and includes import into the territory of Ukraine of registered pharmaceuticals that will subsequently be realized and used in production of finishedpharmaceuticals.
The License Provisions do not apply to activity pertaining to import of pharmaceuticals according to the Law of Ukraine “On Humanitarian Aid” and the Law of Ukraine “On Charity Activities and CharityOrganizations,” or to import of active pharmaceutical ingredients.

2) The State Service of Ukraine on Pharmaceuticals (the “State Service”) issues the licenses. The fee for the license is one minimum wage as of the date on which the decision to grant the license is made(currently the minimum wage is 1147 hryvnias).

3) The license shall be issued based on an application and on other documents as provided for by Article 10 of the Law of Ukraine “On Licensing of Certain Categories of Business Activities” (as of now the documents necessary for pharmaceutical import have not beendetermined).

4 ) To obtain a license, an applicant must have the appropriate material and technical base, a qualified staff and the ability to perform quality control of pharmaceuticals. These requirements are subject to confirmation by the materials of(і) a scheduled audit for compliance with licensing requirements for performing business activity relating to the production or wholesale trade of pharmaceuticals or (іі) an audit prior to the issuance of a license to perform business activity relating to the production of pharmaceuticals or to wholesale trade of pharmaceuticals.
If the mentioned audit was not performed, then compliance with these requirements shall be checked according to the procedure established by the Ministry. Such a procedure, however, has not yet been adopted. Please note that the License Provisions do not envisage what the material and technical base should be and do not contain specific requirements for staff qualifications.

5) The decision to grant/deny a license shall be made by the State Service within 10 working days from the date of the submission of the application. The applicant shall be informed about the decision within three working days of the decision’s being made.
Grounds for denial of the license are: (і) unreliable data in the submitted documents, (іі) an applicant does not comply with the License Provisions according to the submitted documents.

6) The licensee shall: perform a number of written procedures regarding the marking, quarantine and storage of pharmaceuticals: take action if it receives a claim letter regarding possible defects in pharmaceuticals; withdrawal pharmaceuticals from circulation when necessary; and so on. The License Provisions do not establish requirements for the contents of such written procedures.

7) The license shall be issued with an annex including a list of those pharmaceuticals that the licensee is allowed to import. If this list changes, the annex shall changed upon the licensee’s written request.

The License Provisions will become effective on 1 March 2013.

Please note that two drafts regarding the abolishment of mandatory pharmaceuticals import licensing (registered under No. 2196 and No. 2251) are in the study stage in the Parliament of Ukraine.

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We will continue to monitor further developments and will be pleased to answer your questions concerning the above information.

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