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For the import of medicines to Russia the parties need to
submit a manufacturer's certificate and approval of the responsible person of
that organisation regarding the compliance of the imported medications with the
needs built during its state registration.
The State Duma adopts the government-proposed
bill on the mode for entering drugs into civilian circulation. According to the
approved bill, manufacturers imported the medications into the Russian market
by submitting quality data to Roszdravnadzor or receiving a relevant permit for
immunobiological preparations. For the drugs meant for clinical trials,
unregistered medicines used for the provision of medical care, and medications
under examination for state registration don't require any submission of data
and documentation.
The second reading amended the draft law,
under which drug producers or industries importing them into the Russian
Federation must provide a drug test protocol yearly no later than February 1 to
the Roszdravnadzor, and inform no less than one year before the planned
suspension or termination of production.
Remedium
A law has been passed on how to put drugs into circulation.
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