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Russian Federation ceased the need for certification to produce medicines

Russian Federation ceased the need for certification to produce medicines Russian Federation ceased the need for certification to produce medicines
Russian Federation ceased the need for certification to produce medicines Russian Federation ceased the need for certification to produce medicines

What's new?

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.

Source:

Remedium

Article:

Federation Council abolishes mandatory drug certification

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