“The introduction into civil circulation of each series of immunobiological drugs will be carried out on the basis of permission issued by Roszdravnadzor, taking into account the conclusion on the compliance of the series with the requirements established during state registration of the drug,” the government website said in a statement.
The Cabinet explained that changes in the legislation are called upon to create an effective mechanism for the “final” control of medicines that enter civilian circulation.
It is specified that the changes come into force on November 29, 2019.
Earlier it became known that a bill was introduced in the State Duma on the introduction of a compulsory licensing mechanism for medicines.