In this issue:
- Ministry for Industry and Trade is developing definitions for products having no Russian analogues
- Ministry of Healthcare developed amendments to Essential Drugs price regulation rules
- Ministry of Healthcare developed the procedure for sample quality control for pharmaceuticals
- Ministry of Healthcare developed regulations for rational choice of pharmaceuticals names
- Ministry of Healthcare is developing regulations for destruction of counterfeit medical devices
- Ministry of Healthcare developed the Draft Federal Law “On Circulation of Medical Devices”
- Ministry of Healthcare prepared documents for ratifying the European Council Convention on preventing the medical products counterfeiting
Ministry for Industry and Trade is developing definitions for products having no Russian analogues
The Ministry for Industry and Trade informs on development of the Government Resolution “On Adoption of Criteria for Classifying Products as Industrial Products which Have no Analogues Produced in the Russian Federation, and Criteria for Classifying Industrial Products as Products Originating from the Russian Federation".
The Draft is developed for the purposes of:
- providing incentive measures for the local industry;
- establishing the restrictions for goods originating from foreign countries and having no analogues produced in the territory of the EuroAsian Economic Community.
In particular, the draft Resolution presumes that industrial products could qualify for products originating from the Russian Federation provided that they meet the following requirements:
1) the certain required conditions, production and technological stages in course of these industrial products’ manufacturing are performed in the territory of Russia;
2) the value of foreign-origin materials and components (equipment) used in manufacturing of these industrial products does not exceed the certain share of the final sales price;
3) other specific conditions are met, including carrying out R&D activities in Russia, conducting the continuing professional education programs in the territory of Russia, employing Russian citizens under civil law or labor contracts, etc.
The key document validating qualifying of industrial products as products originating from the Russian Federation is a certificate of appraisal issued by the Russian Chamber of Commerce and Industry and the Federal State Autonomous Institution “Russian Technological Development Fund”.
Industrial products could qualify for products having no analogues produced in Russia under the following conditions:
1) the certificate of appraisal is issued by the Russian Chamber of Commerce and Industry and the FSAI “Russian Technological Development Fund” is available;
2) the products are included into the list of technological equipment (including components and spare parts) approved by the Russian Government Resolution # 372 dd. April 30, 2009 “On Adoption of the List of Technological Equipment (Including Components and Spare Parts) which Analogues are not Produced in the Russian Federation and which Import to the Territory of the Russian Federation should not be Subject to Value Added Tax”;
3) an opinion letter of the Ministry for Industry and Trade is issued upon the results of the examination according to the Russian Government Resolution # 1224 dd. 24 December 2013 “On Adopting Prohibitions and Restrictions to Access of Products Originating from Foreign Countries, Works (Services) Rendered by Foreign Parties, to the State Procurements for the Needs of National Defense and Security”.
The document is supposed to enter into force in June 2015.
Ministry of Healthcare developed amendments to Essential Drugs price regulation rules
The document is aimed at improvement of the state pricing regulation rules for Essential Drugs and amends the following legal acts:
- Registration and re-registration rules of maximum ex-factory prices set by pharmaceuticals manufacturers;
- Rules for keeping the state register of maximum ex-factory prices;
- Methodology for calculating the maximum ex-factory prices in course of their registration and re-registration.
Ministry of Healthcare developed the procedure for sample quality control for pharmaceuticals
The purpose of the sample quality control is to confirm pharmaceuticals’ compliance with the applicable pharmacopoeias article or with the corresponding regulatory documentation.
The sample quality control is carried out by Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) and shall include:
- processing of data on the series, batches of pharmaceuticals introduced into circulation in the Russian Federation, which is provided by the participants of pharmaceuticals circulation on mandatory basis;
- selecting of samples of pharmaceuticals for trials with respect to their compliance with regulatory requirements;
- concluding on the possibility of further market circulation of pharmaceuticals based on the performed trials;
- making a decision on putting the pharmaceuticals under the serial sample quality control, in case of the repeated detection of non-compliance with the regulatory requirements and a decision on auditing the pharmaceuticals circulation participant (if necessary).
Public debates on the Draft are scheduled from April 24, 2015 to May 24, 2015.
Ministry of Healthcare developed regulations for rational choice of pharmaceuticals names
The Regulations contain basic principles harmonized with international standards which allow the developer, the holder or the owner of the registration certificate determine the eligibility of the proposed pharmaceutical name for the purposes of state registration in Russia.
Public debates on the Draft are scheduled from April 24, 2015 to May 24, 2015.
Ministry of Healthcare is developing regulations for destruction of counterfeit medical devices
The Ministry of Healthcare informs on development of the Government Resolution “On Adoption of Regulations for Destruction of Adulterated, Poor-Quality and Counterfeit Medical Devices which were Withdrawn from Circulation”.
The document is aimed at protecting the consumers’ interests from harm caused by circulation of counterfeit, poor-quality and unregistered medical devices.
The Resolution is supposed to enter into force in the IV quarter of 2015.
Ministry of Healthcare developed the Draft Federal Law “On Circulation of Medical Devices”
The Draft is supposed to create the consistent legislative base in the area of state regulation of medical devices circulation, that would help:
- create the necessary conditions preventing the medical devices that do not meet the requirements of safety, quality, efficiency from entry into the domestic market;
ensure the competitiveness of domestic medical devices in the local and foreign markets.
Ministry of Healthcare prepared documents for ratifying the European Council Convention on preventing the medical products counterfeiting
The Ministry of Healthcare has placed for public debates the Draft Government Resolution “On Presentation for Ratifying to the President of the Russian Federation of the European Council Convention On Preventing the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Healthcare".
The ratification of the Convention by the Russian Federation activates intergovernmental mechanisms for the protection of public healthcare from the risks related to counterfeit and poor-quality medical devices and pharmaceuticals circulation.
Regulations for selecting of control experts by Ministry for Industry and Trade adopted
The Ministry of Justice registered the Order of the Ministry for Industry and Trade dd. 04.02.2015 # 180 “On approval of application for certification of experts, the list of types of examinations, for which the involvement of experts is required, the criteria for certification of experts, the rules for formation and keeping of the register on certification of experts involved by the Ministry for Industry and Trade to conduct control measures".
The experts involved by the Ministry for Industry and Trade to carry out the control activities, including control over pharmaceuticals production, should have:
- the graduate degree in the relevant area of the activity and/or a certificate of professional development;
- work experience in the chosen area not less than 10 years;
- experience in conducting audits, examinations, trials in the role of an expert.
Draft Law “On Biomedical Cellular Products” adopted at first reading
The Document is aimed at:
- Regulation of relationships arising in course of development, pre-clinical and clinical trials, examination, state registration, production, sale, storage, transportation, usage, destruction, import and export operations with biomedical cellular products for prevention, diagnostics and treatment of diseases (conditions) of a patient, maintenance of pregnancy and rehabilitation of a patient, as well as the donation of biological material for manufacturing of biomedical cellular products;
- Defining fundamental concepts such as "biomedical cellular product," "cellular line", "cell differentiation", "donor of biological material", "safety of biomedical cellular product", "effectiveness of biomedical cellular product";
- Defining the rights and liabilities of participants of biomedical cellular products circulation process;
- Establishing the requirements for state control (supervision) over biomedical cellular products circulation.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.