Russia Published List of Drugs from 7 Nosologies Program Mandatory for Labeling

| By | Drug Label, Russian Pharma

In the Russian Federation, 27 international generic names of medicines of the list from Seven nosologies program are registered and approved for medical use, the mandatory labeling of which in the Russian Federation was introduced on October 1, 2019:

  • moroctocog alpha;
  • nonacog alpha;
  • octocog alpha;
  • coagulation factor VIII;
  • coagulation factor IX;
  • coagulation factor VIII + von Willebrand factor;
  • eptacog alpha (activated);
  • dornase alpha;
  • somatropin;
  • velaglucerase alpha;
  • imiglucerase;
  • fludarabine;
  • rituximab;
  • imatinib;
  • bortezomib;
  • lenalidomide;
  • interferon beta-1a;
  • interferon beta-lb;
  • peginterferon beta-1a;
  • glatiramer acetate;
  • natalizumab;
  • teriflunomide;
  • mycophenolate mofetil;
  • mycophenolic acid;
  • tacrolimus;
  • cyclosporine;
  • anti-inhibitory coagulant complex.

According to Roszdravnadzor, both domestic and foreign drug manufacturers, as well as wholesale and retail organizations, are ready to start compulsory labeling of medicines for 7 high-cost nosologies. In total, 21 domestic manufacturers, 16 holders of registration certificates for foreign medicines and 16 wholesale organizations supply the drugs of this category to the Russian market. The issuance of drugs for 7 nosologies carried out by 3547 distribution points.

The main objective of introducing a system for monitoring the movement of drugs is to protect the population from counterfeit, substandard and counterfeit drugs. From October 1, 2019, citizens will be able to independently verify the legality of medicines from the list of 7 nosologies program in civil circulation.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.