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.