According to the document, the "Russia-origin pharmaceutical" should meet one of the following criteria:
The Ministry for Healthcare and Social Development of Russia prepared the draft Federal law dd. 21.01.2013 "On introducing amendments into the Federal law "On Circulation of Pharmaceuticals" and Article 333.32.1 of the second part of the Russian Tax Code".
In particular, amendments are to include the following:
According to the Presidential Controlling department of Russia, the effective Methodology for determining maximum producers' prices for essentials requires amendments. In particular, unjustified inflation for pharmaceuticals prices should be precluded without reducing their assortment.
As per the Presidential Expert department, the existing Methodology stipulates that the maximum producers' prices for particular pharmaceuticals are determined based on their reference prices in foreign states. The list includes 21 states (Bulgaria, Germany, Spain, Portugal, Czech Republic, Belorussia, Ukraine, Kazakhstan etc.) Whereas, there is a significant number of pharmaceuticals from India and China, being traded in the Russian market at lower prices, however, these states were not included into the reference countries list provided for by the Methodology.
In particular, under the said initiative of the Federal Antitrust service, Rospotrebnadzor should allow registration only for those biologically active supplements which do not contain ingredients included into the state pharmacopoeia.
This information is presented in the resolution of the State Chief medical officer of Russia, Mr. Gennady Onishchenko, as published at Rospotrebnadzor's official web-site.
On 23 January 2013, at the session of the Expert Council for developing competition in medical goods circulation area, the business community representatives discussed the draft Resolution of the Russian Government "On adopting restrictions for supplying medical goods for state and municipal needs".
According to the draft, only Russian, Belorussian and Kazakhstaniproducers of medical goods are to be admitted for participation in state tenders.
In addition, there specific criteria are to be introduced for defining the list of medical goods which could be supplied under state tenders only if produced locally.
The draft Resolution stipulates empowering the Ministry with authorities of approving guidelines for manufacturing set-up (organization) and quality control of pharmaceuticals, as well as issuing opinions on pharmaceutical producers' compliance with requirements thereto.
The Order provides for the unified approach to collecting, processing and presenting to Roszdravnadzor the data on examined medical goods safety, as well as clarifications on practical issues with respect to compliance of applicable law provisions.
The Order is not legally binding and non-compliance should not lead to administrative or other sanctions provided that the applicable provisions of the Russian law are observed.
The Ministry for Healthcare and Social Development of Russia appoved the Order dd. 20.12.2012 No 1175н "On adopting the rules for prescribing pharmaceuticals and prescription forms for pharmaceuticals, their filing, accounting and storage".
The Order stipulates prescribing pharmaceuticals as per the international non-proprietary names (INN), in absence of the INN – per the grouping name, and in absence of both INN and grouping name – per the trade name.
The aim of this requirement is to preclude prescribing particular pharmaceuticals to patients based solely on the consent between the doctor and a pharmaceutical company (which is directly prohibited by the Federal law "On fundamentals of public healthcare in Russia").
As per the official web-site of the Ministry for Healthcare and Social Development of Russia, the document is to be enforced from 1 July 2013.
In the session dedicated to development of competition in the pharmaceutical market, the Minister for Healthcare and Social Development, Mrs. Veronika Skvortsova informed that currently the officials are working on the topic of selling pharmaceuticals and medical goods in retail stores as per an exclusive list.
The Minister noted that in the nearest future the Ministry, together with the FAS and the Ministry for Economic Development, would propose the list of such pharmaceutical products and present it for consideration by a state committee.
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