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Notice of updates !
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KPMG Pharma bulletin, Issue #2, 2012
KPMG Pharma bulletin, Issue #2, 2012
Related content
In this issue:
- The draft law prohibiting the advertising of pharmaceuticals.
- ARPhP prepared suggestions for harmonizing the state registration of pharmaceuticals in the Customs Union member states.
- The draft Order by the Ministry for Healthcare and Social Development “On adaptation of regulations in the area of medical products circulation”.
- The regulation for the ED pricing control adopted.
- Regulations for control over clinical and pre-clinical trials of pharmaceuticals adopted.
- Draft Regulation on permissions for import and export of biological materials resulted from clinical trials.
- The maximum wholesale and retail mark-ups to ED prices adopted by Russian regions in 4th quarter 2011.
- The Unified Customs Union Register of pharmaceuticals to be adopted in the 1st half of 2012
The draft law prohibiting the advertising of pharmaceuticals
According to the announcement by Sergey Kalashnikov, the President of the State Duma Committee for Healthcare, the Committee is drafting a law on prohibition of pharmaceuticals advertising.
However, no further details were specified yet (particularly, which types of pharmaceuticals would be subject to restriction and whether the law would cover advertising in specialized printed media).
ARPhP prepared suggestions for harmonizing the state registration of pharmaceuticals in the Customs Union member states
The new Resolution on licensing pharmaceutical activity dd. 22.12.2011 # 1081 is adopted. This is driven, inter alia, by enactment of the new Federal Law on licensing.
As per the Association of the Russian Pharmaceutical Producers (ARPhP), the draft Regulation on key principles of state registration (re-registration or confirmation of state registration) of pharmaceuticals in the Customs Union member states contradicts to provisions of the national normative laws and should be harmonized.
Consequently, ARPhP proposed adaptation to the draft documents considered by the working group “On mutual acknowledgement of pharmaceuticals registration certificates held by pharma producers in CU member states”.
The above suggestions were forwarded to the Ministry for Industry and Trade, to the Ministry for Healthcare and Social Development of Russia and to the Customs Union Commission.
The draft Order by the Ministry for Healthcare and Social Development “On adaptation of regulations in the area of medical products circulation”
The Regulations stipulate the requirements to the circulation of medical goods in the territory of Russia.
In particular, the document provides for the rules of technical and clinical trials of medical products, their state registration, importation and exportation to / from the territory of the Russian Federation and the state control procedures.
The regulation for the ED pricing control adopted
The pricing control is to be executed by Roszdravnadzor via planned and unscheduled audits of the companies engaged in wholesale and retail trade of pharmaceuticals, with the purpose of verifying their compliance with the ED pricing regulations.
One of the reasons for initiating an unscheduled pricing audit could be a notification from a citizen on facts of pricing regulations violations by a company, submitted to a regional department of Roszdravnadzor.
Regulations for control over clinical and pre-clinical trials of pharmaceuticals adopted
According to the document, Roszdravnadzor is to perform:
- planned and unscheduled audits of legal entities arranging and conducting clinical and pre-clinical trials;
- gathering and analysis of the data submitted to Roszdravnadzor departments on the results of planned and unscheduled audits of legal entities arranging and conducting pre-clinical and clinical trials.
Draft Regulation on permissions for import and export of biological materials resulted from clinical trials
The purpose of the Regulation is to increase the quality and availability of the state service with respect to issuing permissions for import and export of biological materials received as a result of clinical trials, as well as determining the order and standards of providing the said service by the state.
The maximum wholesale and retail mark-ups to ED prices adopted by Russian regions in 4th quarter 2011
The Unified Customs Union Register of pharmaceuticals to be adopted in the 1st half of 2012
As communicated by Sergey Shklyaev, the Head of Department for assurance of control over specific goods of the FST Administration for trade restrictions, currency and export control, the draft treaty between Russia, Kazakhstan and Belorussia in part of developing the Unified CU Register of pharmaceuticals will be adopted already in the first half of this year.
According to Sergey Shklyaev, the document will allow regulating the circulation of pharmaceuticals in the territory of the CU member states. Any changes introduced by the Ministry of any member state into the local register will be immediately integrated into the Unified CU Register. This data would be also furnished to the Customs service of the CU states.
Thus, national registers of all the member states will be valid throughout the Customs Union territory.
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