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The Government Resolution # 979 dd. September 15, 2015 introduces changes to the Government Resolution # 865 dd. October 29, 2010 “On the State Pricing Regulation for Essential Drugs” updating the rules for maximum prices registration and re-registration and establishing the Methodology for calculating the maximum sales prices during their registration and re-registration.
In particular, the updated rules envisage:
KPMG will shortly distribute a separate alert addressing the key points of the updated Rules, which enter into force on October 1, 2015.
The Ministry for Economic Development prepared the Draft Federal Law “On Amendments to the Federal Law #44-FZ dd. April 5, 2013 “On Contractual System in the Sphere of Goods, Works and Services Procurement for State and Municipal Needs”.
The Draft Law proposes introducing an obligatory requirement for the customer to pay for particular stages of the contract execution within 30 days starting from the date of signing the acceptance document for the goods supplied / works performed / services rendered.
Currently the payment due date is specified for private customers only, while the state and municipal customers are entitled to defer the payment up to 120 days.
The Draft Law also empowers the Government to determine the types of activity for which the minimal term of the contract execution by the supplier (contractor, provider) should be established. This rule is supposed to decrease the number of collusions between customers and suppliers by means of fixing a non-typically short contract execution term, as a result of which the only one supplier (usually, affiliated with the customer), is able to perform the contract within the timeframe set.
The proposed amendments are aimed at minimizing the risks for suppliers involved in the state and municipal procurements, as well as ensuring fair competition between the procurements participants.
The document is expected to:
The Order is supposed to enter into force on January 1, 2016.
The Ministry of Healthcare developed the Draft Departmental Order “On Adopting the Procedure for Keeping the State Register of Pharmaceuticals for Medical Use”. The document is aimed at implementation of the Federal Law # 429-FZ dd. December 22, 2015 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals”.
The state register of pharmaceuticals is the federal database providing details on registered pharmaceuticals for medical use, APIs used for production of pharmaceuticals and APIs intended for distribution.
The register is maintained in the electronic form by means of adding register entries, is published at the Ministry’s official webpage and is updated on a daily basis, while the previous versions of the register are also cashed at the webpage.
The Ministry of Healthcare in its Letter # 2071895/25-3 dd. September 8, 2015 informed that the medical devices which were produced or imported into Russia under limited-term registration certificates are permitted for circulation until the end of their shelf life (expiration date), and can be used during this period as prescribed by the corresponding regulatory, technical and maintenance documentation of the manufacturer.
The Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) in its Letter # 01И-1466/15 dd. September 10, 2015 informed that in case of changing a legal entity’s due to the requirements of the Russian Civil Code, no amendments of the registration certificate for a medical device is needed.
At the same time, should Roszdravnadzor receive an application for amending the registration certificate due to the change of the legal entity’s name, such an application shall be processed under the general procedure established by the Rules of the state registration of medical devices, adopted by the Government Resolution # 1416 dd. December 27, 2012.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
© 2017 KPMG Audit LLC, the Mongolian member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (“KPMG International”), a Swiss entity.