• Type: Publication series
  • Date: 6/12/2013

Pharma Bulletin, Issue 5, 2013 

Government of Russia will determine the VAT exemption rules for imported medical goods

The President of Russia Vladimir Putin signed a law establishing the procedure for creating the list of imported medical products that are exempt from VAT.

Specifically, the Russian Government shall be authorized to determine the list of medical products, as well as raw materials and components used in their production, whose import shall be VAT exempt.

Ministry of Justice registers Order on tariff preferences for Russian producers

The Russian Ministry of Justice has registered Order No. 211 dated 17.04.2013 of the Ministry of Economic Development, "On the Conditions for Admitting Goods of Foreign Origin For the Purpose of Placing Orders For the Supply of Goods for Customer Needs”.

The document specifies that, when placing orders to supply goods, including pharmaceuticals, 15% preferences in relation to the contract price shall be granted if applications for participation in state tenders include proposals to supply goods of Russian and / or Belarusian origin.

Second reading to take place in June of draft law on increasing liability for the improper advertising of biologically active additives

The State Duma has scheduled a second reading of the draft law “On Amendments to the Federal Law “On Advertising” and Article 14.3 of the Russian Code of Administrative Offences” (in relation to advertising biologically active supplements).

The document provides for amendments to the Federal Law "On Advertising", in relation to a requirement to stipulate in the advertising of biologically active supplements information that such supplements are not drugs, and places liability for violating the requirements of such advertising not only on advertisers, but also on advertising distributors.

The document also proposes amending Article 14.3 of the Administrative Code, so that the violation of advertising requirements for drugs, biologically active supplements, medical products and medical services are identified as separate offences.

Recommendations elaborated on restricting standards to the advertising of medicines and biologically active additives in the CIS

On 24 May the participants of a meeting of the Coordinating Council on Advertising under the auspices of the Interstate Council on Antimonopoly Policy (ICAP) approved recommendations on the requirements in CIS countries for advertising drugs, medical products, medical equipment, medical services, treatment methods and biologically active additives. The meeting was attended by representatives from Azerbaijan, Armenia, Belarus, Kyrgyzstan, Moldova, Russia, Uzbekistan and Ukraine.

Under the recommendations, the production, distribution and dissemination of advertising of the above goods and services shall be permitted, provided that:
  • a special permit (license), issued in accordance with domestic CIS legislation, is held for their production and sale
  • upon the domestic law of a CIS participating state establishing more stringent requirements related to the advertising of drugs, doctor's prescriptions, medical products, medical equipment, medical services, treatment methods, the adoption of which requires specialized knowledge or training (assigned by a doctor).
These recommendations, prepared based on an analysis of advertising law in CIS participating states, shall be submitted for consideration to the ICAP.

Russia and Italy to create unified database of drug prices

According to FAS head Igor Artemyev, Russia and Italy are to establish a shared database for monitoring drug prices.

Artemyev stated that joint work between the antimonopoly authorities of Russia and Italy will help identify any instances of unreasonable overpricing of medicines.

Artemyev also noted that where price deviations occur, appropriate checks will be able to be carried out. He added that such collaboration is already under way in the CIS.

Comments from Ministry of Health on medical products classification

In letter No. 2041548/25-3 dated 12.04.2013 the Russian Ministry for Healthcare has addressed the issue of determining numerical designations and types for medical products for their classifications.

In particular, work is currently under way to prepare a list of types of medical products using terms that correspond to internationally accepted terminology. Prior to completion of the list, medical products must be classified according to the numeric codes set out in Appendix 1 to Ministry for Healthcare Order No. 4N dated 06.06.2012, "On Approving the Classification of Medical Products".




Victoria Samsonova


+7 (495) 937 44 77 (ext. 14928)