June 2013

Amendments to Licensing Terms on Manufacture of Pharmaceuticals

The amendments to the Procedure of Manufacture, Wholesale and Retail of Pharmaceuticals (the "Procedure") were adopted by the order of the Ministry of Health of Ukraine dated 24 May 2013 (registered on 10 June 2013).

The Procedure was supplemented by the definition of "active pharmaceuticals ingredient" (the "API"), meaning any substance or mixture of substance designated for usage in manufacturing of pharmaceuticals which becomes its active ingredient during such usage.

Such substances:

  • provide pharmacological or other direct impact for humans' body;
  • are used for medical treatment, diagnostics, disease prevention, medical care, etc., being a component of finished pharma products.

It is also specified that packaging of duly registered APIs, which were manufactured and/or purchased from other manufacturers for further sales to licensees engaged in manufacturing of pharmaceuticals in the pharmacies, should be made by manufacturer in line with current legal acts harmonized with the legislation of European Union.

In addition to information provided by APIs' manufacturer, the APIs' packaging should be marked with information on:

  • manufacturer performing the packaging;
  • statement that the API is designated only for resale to licensees engaged in manufacturing of pharmaceuticals in the pharmacies.

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

© Asters 2013
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