20.Sep.2013

The Ministry of Healthcare of the Russian Federation has issued the next version of the draft law “On Amendments to the Federal Law “On Circulation of drugs”

On September, 3rd 2013, the Ministry of Healthcare has released the project of the Federal law “On amendments to the Federal law “On circulation of medicines” and to the section 333.31.1 of the second part of the Tax Code of the Russian Federation”.

In July 2013, the Analytical Center for the Government of the Russian Federation has conducted a series of expert roundtables devoted to the discussion of the present draft law. During the roundtables, representatives of the pharmaceutical community had an opportunity to suggest amendments to the draft law proposed by the Ministry of Healthcare.

The process of the new draft law discussion was characterized as unprecedented both in regards to the volume of work done and the level of involvement of the professional community.

We would like to mark several major changes that might occur in case the last amendments to the law will be adopted:

  • The renewed draft law gives definitions to such notions as pharmaceutical substance, biological drug, orphan drug, biotechnological drug, generic drug, bioanalogue drug, comparator drug, substitutable medicinal products, bioequivalence study of a drug, medicinal product developer, manufacturing site and registration certificate holder.
  • Moreover, the draft law states that the Executive authorities will approve and maintain the list of medicinal forms, the list of Substitutable drugs as well as the register of medical application instructions of such drugs. They will also state the rules for the rational choice of drugs names as well as the rules for the preparation of the information leaflets and the layouts of drugs packages.
  • The draft law also states the rules and describes the procedure of expert review and ethical review of drugs as well as the rules for registration dossier formation.
  • The last, but not the least novelty is the more precise definition of the maximum selling price establishment by the drug manufacturer for each drug from the “List of Vital and essential medicinal products”.

This is far not the first draft of the federal law “On circulation of medicines” proposed by the Ministry of Healthcare during the last several years since its release in April, 2010. And even though some of the representatives of the pharmaceutical industry are still dissatisfied with the proposed changes, hope remains that the golden mean will be found soon and the process of medicines circulation as well as clinical trials conduct in Russia will become easier both for the Russian and foreign companies seeking opportunities on this specific market.