The Council of Federation has adopted a law about simplified registration of pharmaceuticals

01 Jun, 2018 10:12

Senators have approved amendments to the law "On medicine circulation", allowing companies to register generics under one international non-proprietary name, but under different brand names. It expands the possibilities of contract manufacturing for domestic pharmaceutical manufacturers.

The document simplifies the registration procedure for foreign manufacturers of medicines: they will be entitled to file a registration dossier before the completion of the production inspection to comply with GMP rules, presenting only a copy of the resolution about auditing. In case the auditing reveals some violations, the registration may be canceled.

The changes were approved at the meeting of the Council of Federation on May 30, 2018.

At the same time, the State Duma examines a draft law prepared by the Ministry of Health, supplementing the same Federal Law "On medicine circulation ", which provides for the establishment of a mechanism for the "graduation" control of drugs that enter the civilian circulation in Russia.