Russia eases procedure for registering foreign-made medications during emergency - government directive
MOSCOW. April 6 (Interfax) - The Russian government has simplified the procedure of registering medications already registered in foreign countries, particularly in the United States, the European Union and some others, to be used during emergency situations to treat and prevent diseases posing a danger to people.
Prime Minister Mikhail Mishustin has signed a directive endorsing the specifics of the circulation of medications for human use in the face of an emergency, during an emergency or as part of emergency response efforts, in organizing the provision of healthcare to people affected by this, and in preventing and treating diseases posing a threat to the public.
The document published on the government website says that medications to be used during an emergency are to be registered by the Russian Health Ministry within a period of 20 working days after receiving an application and the necessary documents.
The Health Ministry has two days to examine the documents submitted and task an expert institution with studying the quality of this medication and determining its expected benefit-risk ratio.
The document also allows for skipping the expert analysis stage for medications duly registered in the EU member states, the U.S., Canada, and some other countries from a list approved by the Health Ministry.
"The ministry shall register such medications within five working days after receiving the application and documents," it said.