LAW OF UKRAINE

of July 4, 2012 No. 5038-VI

About introduction of amendments to some laws of Ukraine concerning import licensing of medicines and determination of the term "active pharmaceutical ingredient"

The Verkhovna Rada of Ukraine decides:

I. Make changes to the following laws of Ukraine:

1. In the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996 No. 22, Art. 86; 2007 No. 3, Art. 30; 2012 No. 19-20, of Art. 168; with the changes made by the laws of Ukraine of November 3, 2011 No. 3998-VI and of December 20, 2011 No. 4196-VI):

1) in Article 2:

to state paragraph two of part one in such edition:

"medicine - any substance or combination of substances (one or several AFI and excipients) which has properties and is intended for treatment or prevention of diseases at people, either any substance or combination of substances (one or several AFI and excipients) which can be intended for prevention of pregnancy, renewal, adjustment or change of physiologic functions at the person by implementation of pharmacological, immunological or metabolic action or for establishment of the medical diagnosis";

in part two:

in paragraph one of the word "active ingredients (substances)" shall be replaced with words "AFI, products of "in bulk";

paragraphs two, the third and fourth to state in such edition:

"finished pharmaceutical products (medicines, drugs, medicines) - the dosed medicines in type and condition in which they are applied, passed everything production stage (production), including final packaging;

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