KPMG Pharma Bulletin, Issue #6, 2016 (June)
KPMG Pharma Bulletin, Issue #6, 2016 (June)
In this issue:
Pharmaceuticals
- The concept drafted to support the low-price pharmaceuticals manufacturers
- Deputies approved the law on expanding the USAIS system alcohol-containing pharmaceuticals
- The law on biomedical cellular products is signed by the President
- The Ministry for Industry and Trade approved the list of exhibitions and congresses dedicated to pharmaceutical and medical industry development
Medical devices
Other
Pharmaceuticals
The concept drafted to support the low-price pharmaceuticals manufacturers
The Ministry for Industry and Trade prepared and submitted for the Government’s consideration the draft Resolution which should establish special pricing regulations for local manufacturers of pharmaceuticals from the lower price segment.
In the explanatory note to the draft, the Ministry’s representatives highlight the need for setting up a special procedure for re-registering prices for locally produced essential drugs with initially registered prices below RUB 50. The Ministry proposes to allow the local producers of such drugs set the ED prices based on the forecasted margin below 30%.
Deputies approved the law on expanding the USAIS system alcohol-containing pharmaceuticals
On June, 29 the Federation Council approved amendments to the Federal Law "On state regulation of manufacturing and circulation of ethyl alcohol, alcoholic and alcohol-containing products and restricting the consumption (drinking) of alcoholic products" and certain other legislative acts of the Russian Federation.
The Law includes alcohol-containing pharmaceuticals and medical devices (with mass content of ethyl alcohol of more than 0.5 % of the finished dosage volume) into the list of alcohol-containing products.
The Law envisages implementation of the statutory accounting system for production, circulation and transportation of alcohol-containing pharmaceuticals, pharmaceutical substances (ethanol) and medical devices. The Unified Statutory Automated Information System (USAIS) should cover production and purchase of pharmaceutical substances for manufacturing of alcohol-containing pharmaceuticals.
http://asozd.duma.gov.ru/main.nsf/%28Spravka%29?OpenAgent&RN=613394-5
The law on biomedical cellular products is signed by the President
The President of the Russian Federation Vladimir Putin has signed the Federal Law #180-FZ “On Biomedical Cellular Products” dd. June 23, 2016.
The Law regulates activities and relationships related to biomedical cellular products intended for prevention, diagnostics and treatment of diseases and conditions, prenatal care and medical rehabilitation of patients. In addition, it addresses arrangement arising from donation of biological material for the purposes of manufacturing biomedical cellular products.
The Law comes into force from January 01, 2017, excepting for certain provisions which are enacted separately.
http://www.pharmvestnik.ru/images/files/811/fz_180_23_06_16.pdf
The Ministry for Industry and Trade approved the list of exhibitions and congresses dedicated to pharmaceutical and medical industry development
The List contains 28 Russian scientific and research-and-practice conferences and exhibitions in dedicated to pharmaceuticals and medical devices areas, as well as 2 international exhibitions. Overall, 30 events are to take place.
The conferences and exhibitions are being organized to demonstrate the achievements of the industry and to support the market entry of “made-in-Russia” pharmaceuticals and medical devices.
Medical devices
VAT exemption for medical devices is established
The President of the Russian Federation Vladimir Putin has signed the Federal Law N 225-FZ dd. June 30, 2016, establishing VAT exemption for materials and components imported into Russia for manufacturing of medical devices which have no produced locally analogues.
To enjoy the VAT exemption, the importer should provide the customs authorities with the document, confirming the objective of the materials and components use and the absence of their analogues in Russia (in case of importing from the Eurasian Economic Community member states, this document shall be filed to the tax authority).
For additional details on this topic, please refer to the March 2016 issue of KPMG Pharma Bulletin.
Other
Government is to help local manufacturers with obtaining foreign patents
By the Resolution #548 dd. June 17, 2016 the Government of Russia adopted the rules for granting federal subsidies to Russian companies for partial reimbursement of costs for stamp duties paid when licensing Russian inventions and developments abroad.
The subsidies are supposed to be granted to Russian companies which provide services on foreign patenting of inventions and utility models to local manufacturers and exporters. The subsidy recipients will be selected by the Ministry for Industry and Trade.
http://www.pharmvestnik.ru/images/files/811/pp_548_17_6_16.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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