LAW OF UKRAINE

of May 31, 2016 No. 1396-VIII

About introduction of amendments to article 9 of the Law of Ukraine "About medicines" concerning simplification of state registration of medicines

The Verkhovna Rada of Ukraine decides:

1. 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; 2012, Art. No. 19-20, 168, No. 23, Art. 239; 2013, No. 23, Art. 225; 2014, Art. No. 2-3, 41, No. 39, Art. 2012, No. 47, Art. 2052; 2015, No. 24, Art. 164):

The fourth and sixth to state 1) to part in the following edition:

"Are enclosed to the application: materials of preclinical studying, clinical testing and their examinations; pharmacopoeian Article or materials concerning medicine methods of quality control, the project of production schedules or data on the production technology, medicine samples, its packaging; the document confirming payment of the registration fee. Only materials concerning medicine methods of quality control, the materials of the registration file, models of packaging of medicine with marking stated in language for marking of medicines according to requirements of this Law, the instructions for use of medicine stated in language according to requirements of this Law are added to the statement for state registration of the medicine registered by competent authority of the United States of America, Switzerland, Japan, Australia, Canada, the medicine, according to the centralized procedure registered by competent authority of the European Union for application in the territory of these countries or member states of the European Union; the document confirming payment of the registration fee";

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