LAW OF UKRAINE

of November 3, 2011 No. 3998-VI

About introduction of amendments to article 9 of the Law of Ukraine "About medicines"

The Verkhovna Rada of Ukraine decides:

1. Bring in article 9 of the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86; 2007, No. 3, Art. 30) such changes:

Part the ninth to replace 1) with four parts of such content:

"If the medicine registered based on (complete) registration information submitted in full (further - reference/original medicine), is registered in Ukraine for the first time, state registration of other medicine which contains the same active ingredient, as reference/original medicine is possible not earlier than in five years from the date of the first registration of reference/original medicine in Ukraine if another is not provided by this Article. The specified requirement does not extend to cases when the applicant according to the law acquired the right to refer and/or use registration information of reference/original medicine or submitted own complete registration information which meets the requirements to registration information of reference/original medicine.

The term specified in part nine of this Article can be prolonged up to six years if within the first three years after state registration of reference/original medicine by the Ministry of Health of Ukraine or the body authorized by it its application according to one or more indications which are considered such which have special advantage before existing is authorized. Rules and criteria of determination of indications which have special advantage before existing are established by the Ministry of Health of Ukraine. The term determined by part nine of this Article is established if the statement for state registration in Ukraine of reference/original medicine is submitted within two years from the date of its first registration in any country.

For the purpose of ensuring health of the population in case of medicine registration the Cabinet of Ministers of Ukraine according to the law can resolve use of the patented invention (useful model) which concerns such medicine, to person determined by it without the consent of the owner of the patent.

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