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LAW OF UKRAINE

of July 16, 2024 No. 3860-IX

About introduction of amendments to some laws of Ukraine of rather parallel import of medicines

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 with the following changes):

Article 9-1 to add 1) with parts of the eleventh or fifteenth of the following content:

"When implementing the purchases which are carried out by person authorized on implementation of purchases in the field of health care it is without fail allowed to participation in them:

the medicine registered in Ukraine;

the medicine which is not registered in Ukraine for the period of holding procurement procedure, but registered by competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada, the member state of the European Union or registered by competent authority of the European Union according to the centralized procedure.

State registration of the unregistered medicine in Ukraine specified in part eleven of this Article which is bought by person authorized on implementation of purchases in the field of health care after determination of the winner of procurement procedure is performed with such features:

the following documents are enclosed to the application for state registration of medicine:

1) the document confirming registration of medicine in the respective country or registration by competent authority of the European Union according to the centralized procedure;

2) materials of the registration file (can move in paper or in electronic form), based on which registration in the respective country, taking into account all changes made after registration of such medicine was performed;

3) the instruction samples about application and the short characteristic of medicine (in the presence) stated in original language (the language other than state) and the translations of their texts in state language certified by the signature of the applicant or the representative authorized by it;

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