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LAW OF UKRAINE

of May 15, 2025 No. 4454-IX

About introduction of amendments to some laws of Ukraine concerning implementation of provision Bolar

The Verkhovna Rada of Ukraine decides:

I. Make changes to such laws of Ukraine:

1. In the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86 with the following changes):

Part third of Article 5 to exclude 1);

2) in Article 9:

the seventeenth and twenty fourth to exclude parts;

add with part twenty eighth of the following content:

"State registration of medicine is cancelled by cancellation of the registration certificate irrevocably of means on payment of collection for state registration of medicine in the case provided by part five of article 20 of this Law based on the judgment which took legal effect";

3) the first offer of part two of Article 9-1 to state in the following edition:

"Provisions of parts of first or third, the seventh, ninth, eleventh - the fourteenth, sixteenth, eighteenth - the twenty second, twenty sixth, twenty eighth article 9 of this Law extend to medicines which state registration is performed according to this Article";

Article 20 to add 4) with parts four and heel of the following content:

"Medicine realization, in particular the offer to sale, sale, and also the advertizing, promotion of medicine and/or other actions connected with medicine turnover, the owner of registration, the producer the importer and other subjects of circulation of medicines shall perform with respect for intellectual property rights of the third parties.

In case of factual determination of violation of the rights following from state registration of the invention (useful model) owing to the offer to sale, sale, advertizing, promotion of medicine and/or implementation of other actions connected with medicine turnover, the court can make the decision on cancellation of state registration of such medicine".

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