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Pharmaceutical sector
Ernst & Young LLC, Kyiv, Ukraine
Monday, January 14, 2013
Content
► Pharmaceutical import licensing: draft regulatory legal acts are presented for public discussion
The draft regulatory legal acts pertaining to implementation of pharmaceutical import licensing pursuant to the Law of Ukraine “On the Introduction of Changes to Certain Legislative Acts of Ukraine on Licensing Activity for Import Pharmaceuticals and Defining ‘Active Pharmaceutical Ingredient’” No.5038-VI dated 4 July 2012 were published on the official website of the Ministry of Health of Ukraine (hereinafter – MOZ).
The following are the drafts introduced for discussion: draft Resolution of the President of Ukraine “On the Introduction of Changes to the Regulation on the Ministry of Health of Ukraine” (hereinafter – Draft Resolution); the draft Decree of the Cabinet of Ministers of Ukraine “On the Introduction of Changes to the List of Licensing Bodies and the List of Documents That Shall Be Attached to the Application for Issuance of a License for a Certain Type of Business Activity” (hereinafter – the Draft Decree).
The Draft Resolution expands the range of authorities assigned to the MOZ. It states that the MOZ’s authorities shall include:
• Adopting the licensing terms for conducting business pertaining to pharmaceutical import;
• Issuing the license to business entities;
• Maintaining the licensees’ register;
• Adopting the Order for Control of Compliance with Licensing Terms;
• Exercising state control over fulfillment of licensing terms for conducting business pertaining to pharmaceutical import.
The Draft Decree amends the Decrees of the Cabinet of Ministers “On Adoption of the List of Licensing Bodies” dated 14 November 2000 No.1698 and “On Adoption of the List of Documents That Shall Be Attached to the Application for Issuance of a License for a Certain Type of Business Activity” dated 4 July 2001 No.756. These changes foresee the following:
• MOZ will be the licensing body for business activity pertaining to pharmaceutical import;
• To import pharmaceuticals a legal entity shall submit information on the existence of the relevant material and technical base, of a qualified staff and of the conditions necessary to ensure quality control of pharmaceuticals imported into Ukraine; it will also submit a list of the pharmaceuticals allowed to be imported.
The Draft Resolution states that it will take force on the day it is published. The Draft Decree says that it takes force on 1 March 2013.
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