Roszdravnadzor has launched an initiative to simplify the registration procedure for medical products that pose first-class risk; in particular, it has been proposed to extend until 1 January 2017 the deadline for changing registration certificates.
All Roszdravnadzor initiatives are issued as proposals to amend Government Decree No. 1416 "On Approving the State Registration of Medical Devices" and are referred for consideration to the Ministry for Healthcare of Russia.
At the same time, some of the initiatives have already been approved by the Ministry. In particular, Roszdravnadzor and the Ministry for Healthcare have decided that clinical trials of medical products (that are necessary when obtaining or reissuing a registration certificate) carried out before 1 January 2013 shall be considered valid when preparing documents during 2013 and 2014.
The Russian Ministry for Healthcare has posted on its website a draft Federal Law dated 3 September 2013 "On Amendments to the Federal Law "On the Circulation of Pharmaceuticals" and to Article 333.32.1. of Part Two of the Russian Tax Code".
Throughout July the Russian Government Analytical Center held a series of expert round tables to discuss the draft law, the results of which are available on its official website:
The Association of Russian Pharmaceutical Producers (ARPhP) has elaborated and submitted to the Government its proposals for a system of preferences for Russian drug manufacturers. In particular, ARPhP proposes to differentiate the preferences for contract prices, depending on the degree to which a product has been developed in Russia: 15% for packed products; 30% for finished products; and 40% for the manufacturers of substances. In addition, it was proposed to introduce a mechanism for signing three-year state contracts to supply drugs of Russian origin.
Further ARPhP’s proposals include introducing accelerated expert appraisal procedures for Russian drugs and substances used in the manufacture of drugs included in the List of essential pharmaceuticals and strategically important drugs.
Russian manufacturers are also insisting on creating a mechanism to ensure that products created at public expense be included in state purchases.
In addition, preferences for Russian manufacturers are supposed to include tax and customs exemptions; specifically: the reimbursement of customs duties and VAT, as well as exempting from profits tax the manufacturers of drugs on the list of essential medicines and strategically important drugs.
A public discussion of the draft Russian Government Resolution, "On the Procedure For Approving the List of Drugs, Supply Orders For Which Are To Be Placed According To Their Trade Names" started on August 15.
The draft List will be introduced to the Government by the Russian Federation Government Commission, which consists of the Ministry for Healthcare, the Ministry for Industry and Trade, Federal Antimonopoly Service, medical community representatives, patient associations, and representatives of trustees and the pharmaceutical industry.
The Commission is preparing a proposal for drugs that are on the List of essential pharmaceuticals to be included into the draft List, provided that one of the following conditions are met:
the chemical formula of the original drug is protected as an exclusive right, certified by a patent, for the validity term of the patent,
inability to interchange on the therapeutic action the drugs with the same INN or, in the absence of INN – the same chemical and grouping items.
A communication from an individual or entity, with the respective justification, shall act as the ground for considering whether of not a drug should be included on the draft List.
© 2020 KPMG. KPMG refers JSC “KPMG”, “KPMG Tax and Advisory” LLC, companies incorporated under the Laws of the Russian Federation, and KPMG Limited, a company incorporated under The Companies (Guernsey) Law, as amended in 2008.