Changes in Treatment Act pharmaceutical products

June, 26 at meeting of the Russian Government approved the draft federal law "About modifications in the Federal Law" About circulation of drugs. " Now the document will be submitted to the State Duma in the established order.  

The Draft bill is aimed at improving the procedures for state registration of medicines, elimination of defects in terminology, the removal of inefficient, unsafe and defective pharmaceutical products.

The change provides a list of documents forming the registration files, conditions that do not require the provision of a report on the results of the bioequivalence study with the registration of generic drugs for medical use. Determine the conditions of accelerated examination procedure medicines for the state registration of these drugs.

The draft federal law provided its entry into force on 1 January 2015, but not earlier than one month after the date of its official publication.