KPMG Pharma Bulletin, Issue #9, 2015 (September)
KPMG Pharma Bulletin, Issue #9, 2015 (September)
Related content
In this issue:
Pharmaceuticals
- ED prices calculation and registration rules updated from October 1, 2015
- Amendments to the Federal Law on Contractual System for State Procurements placed for public debates
- New rules for storage and transportation of pharmaceuticals developed by the Ministry of Healthcare
- Rules for keeping the state register of pharmaceuticals are developed
Medical devices
Pharmaceuticals
ED prices calculation and registration rules updated from October 1, 2015
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:
- limiting maximum sales prices for generics based on the earlier registered prices for original (reference) drugs;
- establishing the principles and and procedure for re-registering maximum sales prices by EEC and foreign manufacturers;
- extending the necessary volume of information to be disclosed in the application for registration and re-registration of a maximum sales price;
- extending the set of documents to be submitted for registration and re-registration of a maximum sales price.
KPMG will shortly distribute a separate alert addressing the key points of the updated Rules, which enter into force on October 1, 2015.
Amendments to the Federal Law on Contractual System for State Procurements placed for public debates
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.
http://regulation.gov.ru/projects/List/AdvancedSearch#npa=39939
New rules for storage and transportation of pharmaceuticals developed by the Ministry of Healthcare
The Ministry of Healthcare has placed for public debates the Draft Order “On Adoption of Regulations for Good Storage and Transportation Practices for Pharmaceuticals”.
The document is expected to:
- improve the existing regulations on good storage and transportation practices of pharmaceuticals;
- preclude the risk of entering faked, poor-quality, counterfeit pharmaceuticals into the supply chain;
- ensure the conditions for storage and transportation required for due quality, safety and efficiency of pharmaceuticals along the entire supply chain.
The Order is supposed to enter into force on January 1, 2016.
Rules for keeping the state register of pharmaceuticals are developed
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.
http://regulation.gov.ru/projects/List/AdvancedSearch#npa=40042
Medical devices
Circulation of medical devices upon the registration certificate expiration
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.
Legal form change does not require amending the registration certificate
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.
http://www.roszdravnadzor.ru/i/upload/images/2015/9/11/1441960054.84007-1-11105.pdf
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
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