New rates of Unified customs tariff import duties
The Decision of Eurasian economic committee Counsel dd. 02.07.2013 No 45 “On introducing amendments into Unified Commodity nomenclature of international economic activity of Customs union and Unified customs tariff of Customs union with respect to particular goods” adopted new rates of Unified customs tariff import duties for pharmaceuticals starting from 1 September 2013.
In particular, the rates of customs duties would be decreased with respect to particular pharmaceuticals from 10% to 7% and from 5% to 4%. http://www.garant.ru/products/ipo/prime/doc/70327814/
Law on increasing liability for the improper advertising of biologically active additives
Vladimir Putin, President of the Russian Federation, has approved changes to the Federal Law “On Advertising” and to the Article 14.3 of the Administrative Code (see KPMG Pharma-Bulletin edition 34).
Most of the changes concern the advertising of biologically active additives. Adverts must from now on and in all circumstances state that biologically active additives should not be treated as drugs.
The changes include instructions on the length and size of these warning statements, giving rules governing all forms of advertising, including television, radio, video and cinema advertising.
Fines for breaking the rules governing the advertising of these biologically active additives, as well as for the advertising of drugs, medical equipment and medical services, are also being introduced. http://www.garant.ru/hotlaw/federal/485350
Administrative regulations of Ministry for Industry and Trade for rendering the public service on licensing production of drugs
The Ministry for Trade and Industry of the Russian Federation has approved Regulations for rendering the public service on issuing licenses for the production of pharmaceuticals. This was confirmed in Directive No. 877 of the Ministry for Trade and Industry, adopted on 07.06.2013.
The administrative regulations define:
- the applicants (legal entities, licensed applicants and licensees);
- procedural requirements with respect to informing on public services rendering;
- types of activity constituting licensed work;
- the scope, sequencing and time frames for the fulfillment of administrative procedures
The timing for making decisions on the granting of licenses for the manufacturing of drugs cannot exceed 45 working days, starting from the date the application and documents were received.
The regulations also set out the forms of control over fulfilling the Regulations and the order for pre-court (out-court) appeals against actions of the public officials. http://ria-ami.ru/news/108705
Application of VAT to the most important domestic and foreign-made medical equipment
The Russian Federal Tax Service issued Letter N ED-4-3/10941@ of 18.06.2013 stating that for the most important medical technologies, both manufactured domestically and in foreign jurisdictions, VAT will not be applied so long as a registration certificate accompanies these equipment. The list of items that will not be taxed is contained in the Decree N 19 of the Russian Federation of 17.01.2002. http://www.referent.ru/1/215151
Time frame for changing registration certificates for medical equipment extended
A joint meeting of the leadership of Roszdravnadzor (the Federal Service on Surveillance in Healthcare) and the Russian Ministry for Healthcare recently took place under the chairmanship of the Deputy Minister for Healthcare, Igor Kagramanyan. The meeting discussed the prolongation of the time frame within which medical equipment registration certificates can be replaced, and also how to simplify procedure for registering low-risk equipment.
At the end of the meeting, Igor Kagramanyan issued instructions for amendments to be drafted to the Government’s Decree No. 1416 of 27.12.2012, increasing the certificate replacement deadline for medical equipment from 1 January 2014 to 1 January 2017. http://ria-ami.ru/news/106277
The Ministry for Industry and Trade to provide preferential treatment in government purchases to domestic producers of medical equipment
The Ministry for Industry and Trade is proposing that the Russian government adopt a new law on “Aspects of the placing orders for the supply of medical good for state needs of the government of the Russian Federation, its constituent territories, or those of its municipalities”.
The document suggests that, up until 31 December 2020, only producers of medical goods originating in the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan can participate in tenders to meet the needs of state and municipal authorities.
This will also exclude medical goods manufactured abroad in locations that are not included in localization agreements, if the object of purchase is listed on the Register of Medical Equipment restricted from being purchased in State and Municipal tenders.
Including these types of medical equipment on the Register will increase the restrictions already present on these goods. The Register will be compiled and maintained by a commission from the Ministry of Industry and Trade.
A medical good will be classified as manufactured in the Russian Federation, Republic of Belarus or Republic of Kazakhstan if the percentage of value added to it by foreign-made parts is less than 50% of the end product’s total value. http://www.pharmvestnik.ru/publs/lenta/v-rossii/minpromtorg-nameren-predostavitj-otechestvennym-proizvoditeljam-medoborudovanija.html
Guidelines on preparing pharmaceuticals safety reports
Guidelines have been prepared setting out the basic principles to be followed when preparing periodic reports on the safety of medicines (POBLP).
The recommendations address issues of how reports are to be prepared and presented, and include guidance on submission timings, how much information needs to be disclosed concerning the safety of the medicine in the POBLP report, the structure and format of POBLP reports, and how they are to be submitted to Roszdravnadzor (the Federal Service on Surveillance in Healthcare). http://www.garant.ru/products/ipo/prime/doc/70316628/