The rules set out detailed information on the principles of due process related to active (pharmaceutical) substances used as raw materials. Compliance with the regulations will be taken into account when issuing to pharmaceutical companies licenses to manufacture drugs.
Thus, starting from 1 January 2014, according to the Law “On circulation of Pharmaceuticals” production of all pharmaceutical companies should be in compliance with GMP standards.
The draft law introduces:
In addition, clarifications have been introduced to the existing law related to terms already in legal use, and additional requirements have been added with respect to the regulatory requirements for registration certificate holders of the subject medical products. Furthermore, the following changes should be noted:
The final version of the draft law will be submitted to the Russian Government in early November, and to the State Duma by the end of the year.
Drug insurance refers to the system in which, when purchasing medicines prescribed by a doctor, the patient who has a compulsory health insurance policy pays only a portion of their cost, with the remainder being covered by the policy.
Under plans set out in the law, the drug insurance system, or other system for reimbursing the cost of drugs, will be introduced in Russia not earlier than 2016; however, for this happen, pilot projects must be conducted in several Russian regions.
During 2013 regions must prepare for the launch of a pilot project. If the experiment proves to be a success, then the system will be rolled out across the country. However, the drug insurance system will not be implemented throughout Russia until 2015, due to financial constraints.
In the Beloholunitsk territory of the Kirov Region a drug insurance project has been already launched. This is the second territory in Russia to take part in the new project.
Russian Government Decree No. 1702 of 21 September has approved the plan to implement the Russian Federation “Development of Healthcare” state programme for 2013 and for the 2014 and 2015 planning periods.
Of special note is that as part of the implementation of Subprogramme 1 the following should take place:
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