LAW OF UKRAINE

of August 12, 2014 No. 1637-VII

About introduction of amendments to the Law of Ukraine "About medicines" concerning enhancement of procedure for providing the population with the medicines intended for treatment of socially dangerous and serious illness

The Verkhovna Rada of Ukraine decides:

I. Introduce in the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86 with subsequent changes) the following changes:

1. In Article 9:

Part third to add 1) with the words "including country name, number and registration date";

Part the fourth to add 2) with the offer of the following content: "Only materials concerning medicine methods of quality control, models of packaging of medicine with marking, stated in language for marking of medicines according to requirements of this Law are added to the statement for state registration of the medicine intended only for treatment of tuberculosis, HIV/AIDS, viral hepatitises, oncological and rare (orphan) diseases, registered by competent authority of the USA, Switzerland, Japan, Australia, Canada or the European Union as medicine, and the instruction for use of medicine stated in language it agrees with requirements of this Law, the document confirming payment of the registration fee";

Part the fifth to add 3) with the offer of the following content: "The decision on registration or refusal in registration of the medicine intended only for treatment of tuberculosis, HIV/AIDS, viral hepatitises, oncological and rare (orphan) diseases registered by competent authority of the United States of America, Switzerland, Japan, Australia, Canada or the European Union as medicine is accepted in seven-day time";

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