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Russia - Draft decision of The Board of the Eurasian Economic Union "On the establishment of the rules of bioequivalence testing of pharmaceutical products within the Eurasian Economic Union"

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Russia - Draft decision of The Board of the Eurasian Economic Union "On the establishment of the rules of bioequivalence testing of pharmaceutical products within the Eurasian Economic Union":

Establishment of requirements for the development of bioequivalence testing design, for bioequivalence testing and for the analysis of results and for the grounds that enable to substitute in vivo tests by in vitro ones.

Proposed date of adoption: 5 July 2016 

Proposed date of entry into force: 1 January 2017   

Final date for comments: 5 June 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.

 

 


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