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European registration of medicines in Ukraine suggested simplifying

Public service drugs proposed to simplify the registration in Ukraine European medicines. In the published draft regulation agency has stated its readiness to accept the registration of medicines in the European Medicines Agency. Market participants believe that, in practice, this simplification does not happen - the document contradicts a number of laws and policies of import substitution pursued by the government.

In Gosleksluzhbe propose to simplify the registration of drugs, have been issued in the EU.

The draft government decree, issued by Ministry of Health on Thursday, companies are asked to provide, drugs have been registered by the European Medicines Agency (European Medicines Agency; EMA) pass state registration by filing only one application to the Ministry of Health. In Ukraine are now drugs such European companies as Berlin-Chemie/Menarini Group, Sanofi-Aventis, Novartis, holding STADA CIS, GlaxoSmithKline and others.

If you accept the terms of the document of registration of new drugs in Ukraine has decreased from 120-240 days to one month. In addition to the market can be derived drugs that are not registered in Ukraine because of bureaucratic delays.

 
Source - http://yurpractika.com/news.php?id=0035798

 


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