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This step will help to resolve the shortage of drugs for
the treatment of some serious diseases such as cystic fibrosis and subside the
already sparked serious concerns from patients.
The Russian Federation Council terminates the
mandatory certification and declaration procedures necessary to produce
medicines in Russia. Except for immunobiological medicinal products, each set
of a therapeutic product that has to be manufactured in the Russian Federation,
the manufacturer submits to Roszdravnadzor a report verifying the medicinal
product quality and its compliance with the needs established during its state
registration.
The therapeutic products that are
manufactured outside Russia and imported in Russia, also have to submit
Roszdravnadzor a manufacturer document declaring the compliance of the imported
medicinal goods with the terms of pharmacopoeial articles, and certification of
compliance with its necessities established during state registration.
For the first three batches of medication
first manufactured or imported for the first time in the Russian Federation,
Federal Law dispenses an added submission of a test report to Roszdravnadzor on
the compliance of a set of a medicinal product with the quality indicators
specified by the test protocol administered by an accredited federal government
institution.
Remedium
Federation Council abolishes mandatory drug certification
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