On 9 December 2014, a law substantially amending Federal Law No. 61-FZ “On Circulation of Medicines” dated 12 April 2010 (the “Law”) was adopted, in its third reading, by the State Duma of the Russian Federation.
These new amendments made to the Law (the “Amendments”) are the most significant amendments since the Law first came into force in 2010. They not only have the purpose of clarifying the Law’s conceptual framework by eliminating some of its shortcomings and improving the rules for the registration, manufacture and quality control of medicines, but also, to some extent, they aim to harmonise Russian laws on the circulation of medicines with international standards.
The Amendments (which must be approved by both the Federation Council and the President in the coming weeks) will come into effect on 1 July 2015. The key changes and innovations that will result from the Amendments coming into effect are described below (please click on each link to be taken to the relevant paragraph):
- Approval of the legal status of a ‘marketing authorisation holder’ in Russia
- Issuing of GMP certificates in Russia
- New timeframes and rules for the state registration of medicines
- Changes to the timeframes for the state registration of medicines
- Possibility of registering generics upon the expiry of the six-year protection period for clinical test results
- Limitation of expedited registration to no more than three generics
- New format of a registration dossier
- New rules for the calculation and registration of the maximum retail prices of vital and essential medicines
- Improved legal regulation of biological, orphan and veterinary drugs
- Biological drugs
- Orphan drugs
- Veterinary drugs
- Drug interchangeability
- Additional grounds for the cancellation of the state registration of a medicine
- Good practices
- State supervision and audits
Vera is a certified ISO 9001:2008 Auditor, with indepth expertise in clinical research..
Prior to joining COREX, Vera worked in the clinical department of Quintiles, and has experience in establishing several Local Depots. Under her strict governence COREX has sussesfully passed 25 audits on EU GCP and GDP scope during the past three years.
Having a Master Degree in Project Management, Denis is responsible for the creation and the development of our project office within COREX, that has successfully realized 68 full-cycle clinical projects in 2014.
- Understand the importance of standartization and quality management
- Analyzing the gaps in current distribution practicies in Russia
- Disscuss the challenges of implementing EU GDP
- Explore the directions on managing partners in clinical supply management