RUSSIAN FEDERATION FEDERAL LAW amending certain pieces of legislation of the Russian Federation in connection with the adoption of Federal Law " Compulsory Medical Insurance " in Russian Russian Federation " Adopted by the State Duma 19 November 2010 Approved by the Federation Council on 24 November 2010 (In the federal laws from 07.11.2011 N 305-FZ; , 28.11.2011 N 339-FZ; dated 07.05.2013 N 104-FZ; dated 27.05.2014 N 136-FZ; of 22.12.2014 N 429-FZ Article 1 Amend the Law of the Russian Federation of 27 November 1992 N 4015 -I " OF THE PRESIDENT OF THE RUSSIAN FEDERATION 56; Legislative Assembly of the Russian Federation, 1998, No. 1, art. 4; 1999, N 47, sect. 5622; 2003, N 50, stop. 4858; 2004, N 30, sect. 3085; 2005, N 10, est. 760; 2007, N 22, sect. 2563; N 49, sect. 6048; 2010, N 17, est. 1988), the following changes: 1) to supplement article 1 with paragraph 6 reading: " 6. The Act applies to insurance organizations that provide compulsory health insurance, taking into account the features established by the Federal Law on Mandatory Health Insurance in the Russian Federation. " (2) Paragraph 2 of article 25, paragraph 2, should read as follows: " The minimum authorized capital of the insurer exclusively for medical insurance shall be set at 60 million roubles. The minimum size of the authorized capital of another insurer is determined on the basis of the base amount of its authorized capital equal to 120 million rubles and the following factors: ". class="doclink "href=" ?docbody= &prevDoc= 102143185&backlink=1 & &nd=102040438" target="contents"> dated 1 April 1996 N 27-FZ "About individual (personified) accounting in the mandatory pension insurance system" (Legislative Assembly Russian Federation, 1996, 1401; 2001, N 44, sect. 4149; 2003, N 1, est. 13; 2005, N 19, sect. 1755; 2007, N 30, sect. 3754; 2008, N 18, st. 1942; N 30, sect. 3616; 2009, N 30, sect. 3739; N 52, sect. 6417, 6454; 2010, N 31, st. (4196) the following changes: 1) the Preamble to add the words ", persons entitled to receive State social assistance, persons entitled to additional State support measures in accordance with the Federal Act of 29 December 2006 N 256-FZ "On additional measures of State support for families with children" (hereinafter referred to as persons entitled to additional State support measures), as well as information on children "; 2), in the fifth paragraph of article 4, "exclusively" to delete, to add to the words " and to the objectives of the mandatory Medical insurance "; 3) Article 6 to be supplemented with paragraph 9, reading: " 9. To take account of persons entitled to State social assistance, persons entitled to additional State support measures, as well as information on children, shall be carried out in accordance with the procedure established by this article. "; " Documents in electronic form containing the said information shall be certified by an electronic digital signature in accordance with the Federal Act of 10 January 2002. of the year N 1-FZ "On electronic digital signature". "; 5) part two Article 16 should be supplemented with the following paragraph: " to provide mandatory health insurance to the Federal Fund of Compulsory Health Insurance for insured persons in the system of individual (personalized) accounting needed for Mandatory health insurance, in accordance with the procedure established by the agreement between the Pension Fund of the Russian Federation and the Federal Compulsory Medical Insurance Fund. " Article 18, paragraph 2, of the Federal Act. Law dated July 24, 1998 N 125-FZ " On compulsory social insurance against accidents at work and occupational diseases " (Legislative Assembly Russian Federation, 1998, No. 31, sect. 3803; 2003, N 28, est. 2887; N 52, sect. 5037; 2007, N 1, article 22; N 30, est. 3806; 2009, N 48, sect. 5745) to supplement subparagraph 13 to read: " 13) to send to the compulsory health insurance funds the decision on the payment of expenses for the treatment of the insured immediately after of a serious accident at the expense of compulsory social insurance against accidents at work and occupational diseases in the form and in the manner decided upon by the insurer in agreement with the Federal Compulsory Medical Insurance Fund. ". Article 4 Amend the Budgetary Code of the Russian Federation (Collection of Laws of the Russian Federation, 1998, No. 31, art. 3823; 2000, N 32, sect. 3339; 2003, N 28, est. 2892; 2004, N 34, sect. 3535; 2005, N 1, est. 8; 2007, N 18, sect. 2117; 2008, N 30, sect. 3597; 2009, N 1, est. 18; N 48, sect. 5733; 2010, N 19, st. 2291; N 31, est. 4185) the following changes: 1) in article 58, paragraph 1: a) in the third paragraph of the "Russian Federation." Replace the words "Russian Federation;"; (b) paragraph 4 should read as follows: " Regulations for allocations to the budgets of the urban districts by the constituent entities of the Russian Federation are uniform for all urban districts of the Russian Federation federal and (or) regional taxes and fees, taxes stipulated by special tax regimes to be enlisted in accordance with this Code and the legislation of the Russian Federation on taxes and charges on the subject's budget Russian Federation. "; 2) in article 84: (a) Paragraph 6 Paragraph 1, after the words "budgets of the constituent entities of the Russian Federation", should be supplemented with the words ", budgets of the compulsory health insurance funds"; (b) paragraph 3 should read as follows: " 3. Provisions of federal laws and (or) regulations of the President of the Russian Federation and (or) normative legal acts of the Government of the Russian Federation providing for subventions from the federal budget (budget The Federal Compulsory Medical Insurance Fund) budgets of the constituent entities of the Russian Federation (budgets of the territorial funds of compulsory health insurance) should contain the order of the calculation of the standards for determining the total volume Subventions relating to the related obligating obligations of the entities The Russian Federation (municipalities) and the Federal Budget Act for the regular fiscal year and the planning period (federal budget law of the Federal Compulsory Medical Fund) "Insurance for the regular financial year and plan period) subject to the approval of the relevant subventions to the budgets of the constituent entities of the Russian Federation (local budgets), the budgets of territorial funds of compulsory medical care," the report said. insurance. "; 3) first paragraph of article 85, paragraph 4, in addition to the words", and also within and within the budget of the Federal Compulsory Health Insurance Fund, provided to the budgets of territorial funds of compulsory health insurance in accordance with the procedure provided for in article 133-2 of the present Codex "; 4) to supplement articles 133-1, 133-2, 133-3 as follows: " Article 133-1. Form of inter-budget transfers, provided from the budget of the Federal Compulsory Medical Insurance Fund Interbudget transfers from the budget of the Federal Compulsory Medical Insurance Fund In the form of: 1) subventions to the budgets of territorial funds of compulsory health insurance; 2) other inter-budgetary transfers to the budgets of territorial funds of compulsory health insurance. Article 133-2. Subvention to the budgets of the territorial mandatory medical funds of the Federal Compulsory Health Insurance Fund 1. Under subventions, the budgets of the territorial funds of compulsory health insurance from the budget of the Federal Compulsory Medical Insurance Fund are the inter-budgetary transfers provided to the budgets of the territorial funds of compulsory health insurance. OF THE PRESIDENT OF THE RUSSIAN FEDERATION THE RUSSIAN FEDERATION Federal laws. 2. Subventions to the budgets of the territorial funds of compulsory health insurance from the budget of the Federal Compulsory Medical Insurance Fund are allocated in accordance with the procedure approved by the Government of the Russian Federation. 3. The draft allocation of subsidies to the budgets of territorial funds of compulsory health insurance from the budget of the Federal Compulsory Medical Insurance Fund is submitted to the State Duma in the draft federal budget law. The Federal Compulsory Medical Insurance Fund for the next fiscal year and plan period is approved in the second reading of the draft Federal Law. Approval of compulsory health insurance budgets of territorial funds not exceeding 5 per cent of the total amount of the relevant subventions, which may be distributed between The budgets of the territorial funds of compulsory health insurance, in accordance with the procedure established by the federal executive authority of the Russian Federation authorized by the Government of the Russian Federation, for the same purpose in the execution of the budget of the Federal Fund compulsory health insurance, without modification of the Federal Law on the Budget of the Federal Compulsory Health Insurance Fund. 4. Subventions to the budgets of the territorial funds of compulsory health insurance from the budget of the Federal Compulsory Medical Insurance Fund, provided for the execution of certain obligating obligations of the entities of the Russian Federation, shall be credited to the budgets of the territorial funds of the compulsory health insurance and shall be spent in the manner prescribed by the Government of the Russian Federation. 5. The procedure (draft methodology) of the allocation of subsidies to the budgets of the territorial funds of compulsory health insurance from the budget of the Federal Compulsory Medical Insurance Fund is submitted by the Government of the Russian Federation as a part of the budget. Documents and materials submitted to the State Duma at the same time as the draft federal law on the budget of the Federal Compulsory Medical Insurance Fund for the regular financial year and the plan period. Article 133-3. Other inter-budget transfers, provided by the Federal Compulsory Health Insurance Fund In cases and procedures provided for by federal laws and (or) adopted in accordance with The Government of the Russian Federation, the budgets of the territorial funds of compulsory health insurance can be provided with other inter-budgetary transfers. ". Article 5 Article 5 Article 11 of the Federal Law dated July 16, 1999 N 165-FZ " On the basics of compulsory social insurance " (Russian Federation Law Assembly, 1999, N 29, p. 3686; 2003, N 1, est. 5; 2004, N 10, est. 836; 2009, N 30, sect. 3739), the following changes: 1), add (6) in addition to the words "in the cases provided for by federal laws"; (2) in addition to the words "in cases provided for by federal laws"; (3) (8) " (8) to maintain a single record of insured persons and insured persons, the receipt and expenditure of compulsory social insurance on the basis of uniform (universal) identification marks, Implement compulsory social insurance Information interaction and mutual reconciliation of the veracity of the information submitted for the maintenance of personalized accounting of insured persons by concluding appropriate agreements; ". Article 6 Law of 6 October 1999 N 184-FZ " On the general principles of the organization of legislative (representative) and executive bodies of state power of the Russian Federation Russian Federation, 1999, No. 42, art. 5005; 2003, N 27, sect. 2709; 2005, N 1, st. 17, 25; 2006, N 1, sect. 10; N 23, Art. 2380; N 30, sect. 3287; N 31, sect. 3452; N 44, sect. 4537; N 50, st. 5279; 2007, N 1, sect. 21; N 13, est. 1464; N 21, sect. 2455; N 30, sect. 3747, 3805, 3808; N 43, st. 5084; N 46, st. 5553; 2008, N 29, st. 3418; N 30, est. 3613, 3616; N 48, sect. 5516; N 52, sect. 6236; 2009, N 48, sect. 5711; N 51, est. 6163; 2010, N 15, sect. 1736; N 19, est. 2291; N 31, est. 4160; N 41, est. 5190; Russian newspaper, 2010, 10 November) the following changes: 1) in article 26-3: (a) in paragraph 1 of the phrase "federal state extrabudgetary funds" should be replaced by "Russian State extrabudgetary funds" of the Russian Federation ", to supplement the proposal by the following:" The peculiarities of the financial security of such powers from the budgets of State extrabudgetary funds of the Russian Federation are established by federal laws on specific species of compulsory social insurance. "; b) in paragraph 2: 21) to provide medical assistance in the territory of the constituent entity of the Russian Federation in accordance with the territorial programme of State guarantees to citizens OF THE PRESIDENT OF THE RUSSIAN FEDERATION the authorities); "; sub-paragraph 22 should read as follows: "22) payment of insurance premiums on compulsory health insurance of non-working population;"; , in paragraph 7: paragraph 5, amend to read: " The rights and duties of the federal authorities THE RUSSIAN FEDERATION, THE RUSSIAN FEDERATION, THE RUSSIAN FEDERATION, THE RUSSIAN FEDERATION THE RUSSIAN FEDERATION (Chief Executive Officer OF THE PRESIDENT OF THE RUSSIAN FEDERATION of the State extrabudgetary fund of the constituent entity of the Russian Federation exercising the respective powers; "; sixth paragraph after the words" executive authority of the constituent entity of the Russian Federation "to be supplemented by the words" and (or) of the authorities of the territorial State Federation "; paragraph seventh after the words" budget of the constituent entity of the Russian Federation "to be supplemented with the words", the budget of the territorial State extrabudgetary fund of the subject of the Russian Federation "; paragraph 8, after the words" budgets OF THE PRESIDENT OF THE RUSSIAN FEDERATION class="ed"> (expandable-Federal Law dated 07.05.2013 N 104-FZ) (Unused-Federal Law of 07.05.2013 N 104-FZ) Paragraph 15 after "the budgets of the constituent entities of the Russian Federation" to be supplemented by the words " or from the budget of the Federal Compulsory Health Insurance Fund to the budgets of territorial State extrabudgetary resources. In paragraph 2 of Article 2611: (a) the following wording: "l) the equipment needed to provide medical care in medical facilities;" (e) Subparagraph (e) to be repealed. Article 7 Amend Part Two of the Tax Code of the Russian Federation (Collection of legislation of the Russian Federation, 2000, N 32, sect. 3340, 3341; 2001, N 1, st. 18; N 33, est. 3413; N 53, sect. 5015; 2002, N 22, Text 2026; N 30, sect. 3027; 2003, N 1, sect. 2, 6; N 28, est. 2886; N 52, sect. 5030; 2004, N 27, sect. 2711; N 34, st. 3520, 3524; N 45, sect. 4377; 2005, N 1, st. 30; N 24, est. 2312; N 30, sect. 3130; N 52, sect. 5581; 2006, N 10, est. 1065; N 31, est. 3436, 3443; N 45, est. 4627, 4628; N 50, sect. 5279; 2007, N 1, sect. 39; N 22, sect. 2563; N 23, st. 2691; N 31, sect. 3991, 4013; N 45, est. 5417; N 49, sect. 6045, 6071; N 50, sect. 6237, 6245; 2008, N 27, sect. 3126; N 30, est. 3614, 3616; N 48, est. 5504, 5519; N 49, sect. 5723; N 52, 6237; 2009, N 1, sect. 31; N 11, est. 1265; N 29, st. 3598; N 48, sect. 5731, 5737; N 51, est. 6153, 6155; N 52, sect. 6455; 2010, N 19, sect. 2291; N 25, est. 3070; N 31, st. 4198; N 32, sect. 4298; N 45, sect. 5756) The following changes: 1) Article 149, paragraph 3, subparagraph 7, complete with the following paragraphs: " Trust funds received by health insurance organizations participating in compulsory health insurance from compulsory health insurance in accordance with the compulsory health insurance scheme; funds received by health insurance organizations are compulsory Medical insurance from territorial fund Compulsory health insurance and the cost of compulsory health insurance under the compulsory health insurance agreement (within the limits set by the regulation) OF THE PRESIDENT OF THE RUSSIAN FEDERATION the remuneration of the Implementation of the actions required by the compulsory health insurance agreement. "; 2) in article 251, paragraph 1: (a) paragraph 14, add the following paragraph: " in the form of targeted Funds received by health insurance organizations participating in compulsory health insurance from the compulsory health insurance fund under the compulsory medical insurance agreement (a) (b) (c) (b). power; 3) Article 270, paragraph 48-1, to read as follows: " 48-1) in the form of funds transferred to medical organizations for the payment of medical assistance to the insured under the contract of supply and payment "Medical assistance for compulsory health insurance concluded under the laws of the Russian Federation on compulsory health insurance;"; 4) article 294-1, as follows: " Article 294-1. The considerations for determining the revenue and expenses of health insurance participating organizations are health insurance 1. The proceeds of compulsory health insurance, which are compulsory health insurance, except those provided for in articles 249 and 250 of this Code, are also covered by means, Compulsory health insurance in accordance with the compulsory health insurance financial guarantee agreement for compulsory medical care The Conference of the Parties, provided for by the said treaty. 2. The costs of compulsory health insurance cover the costs of compulsory health insurance, except for those provided for in articles 254-269 of this Code; incurred by designated organizations in implementing compulsory health insurance. ". Article 8 Article 8 Make Russian Federation Code OF THE PRESIDENT OF THE RUSSIAN FEDERATION 1; N 44, sect. 4295; 2003, N 27, sect. 2700, 2708, 2717; N 46, st. 4434; N 50, st. 4847, 4855; 2004, N 31, st. 3229; N 34, st. 3529, 3533; 2005, N 1, st. 9, 13; N 10, est. 763; N 13, est. 1077; N 19, est. 1752; N 27, sect. 2719, 2721; N 30, est. 3104, 3131; 2006, N 1, st. 10; N 10, est. 1067; N 12, est. 1234; N 17, est. 1776; N 18, st. 1907; No. 19, sect. 2066; N 23, st. 2380; N 31, st. 3420, 3438, 3452; N 45, sect. 4641; N 50, sect. 5279; N 52, sect. 5498; 2007, N 1, st. 21, 29; N 30, sect. 3755; N 31, st. 4007; N 41, est. 4845; N 43, sect. 5084; 2008, N 18, sect. 1941; N 30 3604; 2009, N 7, est. 777; N 23, st. 2759; N 26, st. 3120, 3122; N 29, 100. 3642; N 30, stop. 3739; N 52, sect. 6412; 2010, N 1, st. 1; N 21, sect. 2525; N 23, st. 2790; N 30, sect. 4006, 4007; N 31, est. 4164, 4195, 4207, 4208), as follows: 1) Paragraph 1 of Article 15.32, after "Violation" by the word "policyholders"; 2) paragraph 4, paragraph 4, of Article 28.3, amend to read: " (4) Officials Persons from State extrabudgetary funds on administrative offences under articles 15.3, 15.4, 15.6 (1), 15.6 (1), 15.7 (1), 15.8 (in respect of administrative offences relating to the payment of contributions) (a), (c), (c), (c), (b) and (c) 15.10, articles 15.32, 15.33 of this Code. The list of officials authorized to draft administrative offences under this paragraph shall be approved by the heads of State extrabudgetary funds; ". Article 9 Article 9 Federal Act No. 131-FZ of 6 October 2003 on the general principles of the organization of local self-government in the Russian Federation OF THE PRESIDENT OF THE RUSSIAN FEDERATION 3822; 2005, N 1, st. 17, 25; 2006, N 1, sect. 10; N 23, Art. 2380; N 30, sect. 3296; N 31, 100 3452; N 43, sect. 4412; N 50, sect. 5279; 2007, N 1, sect. 21; N 21, est. 2455; N 25, st. 2977; N 43, sect. 5084; N 46, st. 5553; 2008, N 48, sect. 5517; N 49, sect. 5744; N 52, est. 6236; 2009, N 48, sect. 5733; N 52, est. 6441; 2010, N 15, sect. 1736; N 45, sect. 5751) The following changes: 1) Article 15, paragraph 12, part 1, paragraph 12, should read: " 12) the creation of conditions for the provision of medical assistance to the population within the municipal area (excluding the territories of settlements, List of Territories included in the list of territories whose population is provided by medical care in medical institutions under the authority of the federal executive authority, which is included in the of the population of individual Territories) in accordance with the territorial programme of State guarantees for the provision of free medical assistance to the citizens of the Russian Federation; "; (2) paragraph 6 of article 15, paragraph 6, 1 to be declared void; 3) paragraph 14, paragraph 14, of article 16 " (14) Creation of conditions for the provision of medical assistance to the population in the territory of the city district (with the exception of the territories of the urban districts included in the approved by the Government of the Russian Federation a list of the territories whose population is provided with medical care in the Medical facilities under the federal executive authority responsible for the provision of medical and health services to the population of the individual territories) under the territorial programme of State guarantees of Russian Federation citizens of free medical assistance; "; 4) paragraph 8 of part 1 of Article 16-1 shall be declared void; 5) (Spaced by Federal Law from 27.05.2014 N 136-FZ) Article 10 Paragraph 9 of Part 1 of Article 18 of the Federal Law of July 26, 2006 N 135-FZ On Protection Competition Law of the Russian Federation, 2006, N 31, Art. 3434) supplement the words "(except for compulsory health insurance, for which the peculiarities of the selection of financial organizations (insurance medical organizations) are established by the Federal Law" On compulsory medical insurance in the Russian Federation ")". Article 11 Article 10, paragraph 2, of the Federal Law of 27 July 2006 N 152-FZ "On personal data" OF THE PRESIDENT OF THE RUSSIAN FEDERATION 3451; 2009, N 48, sect. 5716; 2010, N 31, est. 4173) supplement paragraph 8 with the following: "8) Personal data processing is carried out for the purpose of compulsory social insurance under federal laws on specific types of compulsory social insurance". insurance. ". Article 12 OF THE PRESIDENT OF THE RUSSIAN FEDERATION The Federal Fund for Compulsory Medical Insurance and the territorial funds of compulsory health insurance " (Legislative Assembly of the Russian Federation, 2009, N 30, sect. 3738; N 48, st. 5726; 2010, N 19, st. 2293; N 31, est. 4196; N 40, sect. 4969; N 42, est. 5294) The following changes: 1) in the name of the word "and the compulsory health insurance funds" delete; (2) in Part 1 of Article 1 of the word " and the territorial funds of compulsory health insurance (yes also-compulsory health insurance funds) "delete; 3) in article 3, paragraph 1, of the words" compulsory health insurance funds "to replace the words" The Federal Compulsory Health Insurance Fund "; 4) Part 2 Article 6 of the Constitution, paragraph 4, of Part 2, paragraph 4 12. In article 14: (6) in article 14: (a), in Part 2, the word "funds" should be replaced by the word "funds"; in Part 2, the word "funds" should be replaced by the word "funds"; 7) in article 15: (a) In Part 8, the words "and the territorial health insurance funds" should be deleted; (b) in paragraph 1 of Part 9 the word "funds" should be replaced with the words "Federal Fund"; 8) in article 16: (a) in Part 3 The words "and territorial funds of compulsory health insurance" should be deleted; 9) in article 58: (a) in the name of the number "2011-2019" to be replaced by "2012-2027"; class="ed"> (In the wording of the Federal Law of 07.11.2011) N 305-FZ b) Part 2 should read: " 2. The following insurance premiums are applicable for the insurance contributors referred to in paragraphs 1 to 3 of this article during the 2012-2014 period: ------------------------------------ | -------------- | --------------- Name | 2012 | 2013-2014 | -------------- | --------------- Trust Fund of the Russian Federation 16.0% 21.0% of the Federation Social Insurance Fund 1.9% 2.4% of the Russian Federation Federal Fund 2.3 per cent 3.7 per cent. "; medical (c) Part 3, to read: " 3. The following premium rates apply for the insurance contributors referred to in paragraphs 4 to 6 of Part 1 of this Article in the 2012-2019 years: ---------------------- | -------------- | --------------- Name | 2012-2017 | 2018 | 2019 | | years | | ---------------------- | -------------- | --------------- Pension Fund 8.0% 13.0% 20.0% of the Russian Federation Social 2.0% 2.9% 2.9% OF THE PRESIDENT OF THE RUSSIAN FEDERATION 5.1 percent 5.1 percent. "; mandatory health insurance 10) in Article 58-1: a) Part 1: " 1. For organizations that have been granted the status of a project participant in research, development and commercialization of their results, in accordance with the Federal Act of 28 September 2010, N 244-FZ "On the Innovation Centre" Skolkovo "(hereinafter referred to as" the participants ") (a) The following insurance contribution rates apply within 10 years of their receipt of the project participant's status from the first day of the month following the month in which they received the status of the project participant: | ------------------------- | ------------------------- | --------------------- | ----------------- | | Pension Fund | Social | Federal Fund | | Russian Federation | | Insurance | | Insurance | | | Health | | | Insurance | | ------------------------- | --------------------- | --------------------- | ----------------- | 14.0% 0.0 Percentage of 0.0 percent. "; (In the wording of Federal Law of 28.11.2011) N 339-FZ) b) the third sentence of Part 3 shall be deleted. Article 13 Article 13 of the Federal Law of 12 April 2010 No. 61-FZ "On the Treatment of Drugs" (Assembly OF THE PRESIDENT OF THE RUSSIAN FEDERATION 1815; N 42, sect. 5293) the following changes: 1) Part 3 of Article 17 should read: " 3. The fee for the services of the experts of the ethics board is based on a contract concluded between the Commissioner of the Federal Executive for which the Ethics Council is established, and the expert of the ethics council, from the budget appropriations, The authorized federal executive body, which established the ethics council, in the federal budget for the corresponding year to ensure its activity, and in the amounts fixed by the Government of the Russian Federation. " (2) Paragraph 16 of article 18, paragraph 16, should be supplemented with the following: of content: "x) conditions of leave;"; 3) (Spspent force-Federal Law of 22 December 2014. N 429-FZ) 4) in Part 5 of Article 23 of the phrase "as well as a sample of the pharmaceutical substance" substitute " and, where appropriate, the sample of the pharmaceutical substance, the test of micro-organisms, cell cultures, samples of substances used to control the quality of the drug by comparing the drug tested with them, "; 5) in article 29: (a) Part 2, as follows: " 2. The confirmation of the state registration of the drug is carried out on the results of the examination of the relation of the expected benefit to the possible risk of the drug use, as well as the examination of the quality of the drug carried out by the drug In the event of changes to the regulatory documentation or a regulatory document. "; b), Part 3 should read: " 3. A document confirming the payment of the state fee for the confirmation of state registration of medicinal products for medical use, or veterinary medicine, a document containing the results of the monitoring of the safety of the drug conducted by the applicant in the form prescribed by the appropriate federal executive body authority. Normative documentation or regulatory document, draft instruction on the use of a drug, draft primary packaging and secondary (consumer) packaging of a drug are attached to the statement of approval State registration of a drug only if they are amended. "; , paragraph 2 of Part 4, paragraph 2 should read: " (2) decides whether or not to conduct the drug Expert opinion on the potential risk of drug use " (...) (...) (...) The basis for the refusal of the examination of the expected benefit to the possible risk of the use of a drug and (or) examination of the quality of the drug is the submission of the documents referred to in Parts 1 and 3 of this Annex. The articles, incomplete or absent in the documents submitted to the documents which should be reflected in them. "; (d) Part 6, amend to read: " 6. The examination of the ratio of the expected benefit to the possible risk of the use of a drug and (or) examination of the quality of the drug in order to confirm the state registration of the drug is carried out on the basis of of the documents referred to in Part 3 of this article, in the manner prescribed by Parts 5 to 8 of Article 23 and Article 24 of this Federal Law. "; "x"; 7) in article 39 (2): (a) editions: " 7-1) information about medical organizations in which a clinical trial of a drug for medical use (full and abbreviation, organizational and legal form, place) is to be conducted of the location and location of the activity, telephone, telefax, e-mail address of the medical organization); "; (b) paragraph 8 restate: " 8) a copy of the contract of compulsory insurance concluded in accordance with the model rules of compulsory insurance, c (c) An indication of the limit of the number of patients participating in the clinical study of a pharmaceutical drug for medical use; "; , paragraph 10, paragraph 10, should read: " 10) a document produced by the manufacturer of a drug containing indicators (characteristics) of a drug produced for clinical research. "; 8) to supplement article 40 with Part 3-1 reading: " 3-1. The head of the medical organization for a period not exceeding three working days from the day of the start of clinical trial of the medical drug for medical use, informs the Commissioner of the federal executive body about this The authorities who have given the permission to carry out the study in accordance with the form they have established. "; 9), article 44 should be amended to read:" Article 44. Mandatory life insurance, health of patient participating in clinical drug study for medical application 1. The organization, which has been granted permission to conduct a clinical trial of a medical drug for medical use, is obliged to insure the risk of harm to life, to the health of the patient as a result of conducting a clinical trial a clinical trial of a drug for medical use at its own expense through the conclusion of a compulsory insurance contract. 2. The subject of compulsory insurance is the patient's property interest in the infliction of harm to his life or health as a result of the clinical study of the medical drug for medical use. 3. The insurance contract of the compulsory insurance is the death of the patient or the impairment of his/her health, including the establishment of a disability, if there is a causal link between the occurrence of the event and the participation a patient in a clinical trial. 4. Claims for compensation for harm caused to a patient's life or health shall be made within the time limits prescribed by civil law. 5. The amount of the compulsory insurance benefit is: 1) in the case of death of the patient two million rubles per patient who participated in the clinical trial of the drug; 2) " Deteriating patient: (a) disability I group, one million five hundred thousand roubles for each patient who participated in the clinical trial of the drug; b) 1 million rubles ($1 million) for each group's disability. of a patient who participated in the clinical trial of the drug; in), which resulted in the establishment of disability of the group III, five hundred thousand roubles for each patient who participated in the clinical study of the drug of the drug; g) does not result in the establishment of a disability, no more than 300 thousand rubles for each patient who participated in the clinical trial of the drug. (Spconsumed by Federal Law of 22.12.2014) N 429-FZ 7. The contract of the compulsory insurance cannot be less than the period of the clinical trial of the drug. 8. The terms of the compulsory insurance contract, including insurance rates for compulsory insurance, the list of necessary documents for the implementation of the insurance payment, the order of the holder of the individual identification code Patient's insurance, the order of informing the insurer about the medical treatment of patients subjected to clinical trial, the procedure for the payment of the insurance premium, the procedure for the implementation of certain of the rights and obligations of the parties The compulsory insurance policy is established by the model rules of compulsory insurance. 9. In case of harm to the life of the patient who participated in the clinical trial of the drug, the beneficiaries under the contract of compulsory insurance are citizens entitled to compensation in the event of death of the breadwinner in the case of death in accordance with the civil law, in the absence of the parents, the spouse, the children of the deceased patient who participated in the clinical trial of the drug, in the event of the death of the patient who participated in the clinical trial of a drug that has no independent income, The person who was dependent on him for the cost of burial expenses of the patient who participated in the clinical trial of the drug is a person who has incurred such expenses. 10. The amount of insurance to compensate for the harm caused to the patient's life, who participated in the clinical trial of the drug, is distributed among the beneficiaries in proportion to their number in equal shares. 11. In the event of an insurance event, the patient who participated in the clinical trial of the drug is entitled to submit a claim for damages to the insurer directly to the insurer. The insurance payment is carried out by the insurer within thirty days from the date of submission of the necessary documents. The patient who participated in the clinical trial of the drug or the beneficiary is obliged to inform the insurer for the payment of the individual identification code of the patient established by the policyholder in accordance with with the model rules for compulsory insurance. 12. Prior to the full determination of the amount of damages to be recovered, the insurer who participated in the clinical trial of the drug, or the application of the beneficiary, is entitled to make part of the insurance payment, the corresponding actual part of the damage caused. 13. Insurance payments under the compulsory insurance contract shall be made irrespective of the payments due under other types of insurance. 14. The patient is not allowed to participate in the clinical trial of the drug in the absence of a contract of compulsory insurance. 15. Monitoring of the performance of the organization authorized to carry out a clinical study of the medicinal product prescribed by this article on compulsory life insurance, health The patient participating in the clinical trial of the drug is carried out by the authorized federal executive authority who gave permission to conduct clinical studies of medicinal products for Medical use. "; 10) in article 71: (a) Part 3-1-3-4 should read " 3-1. State registration of medicines for medical use, submitted for State registration before the day of entry into force of this Federal Law, and State registration of medicines for Medical applications submitted for the examination of medicines prior to the day of the entry into force of this Federal Act for subsequent State registration shall be carried out on the basis of documents and data submitted before the day the entry into force of this Federal Act, as well as declarations State registration of medicines supplied by the manufacturer of medicines or an authorized person in accordance with this Federal Law to the authorized federal executive body before March 1 In 2011, without the requirement of payment of the state duties under the laws of the Russian Federation on taxes and duties. 3-2. Confirmation of the State registration of medicines for medical use, submitted in support of State registration prior to the date of entry into force of this Federal Act, and confirmation of the State Registration of medicines for medical use, submitted for the examination of medicines prior to the day of the entry into force of this Federal Act for subsequent confirmation of their state registration, are carried out on the basis of documents and data submitted prior to the date of entry into force of the The strength of this Federal Act, as well as the statements on the confirmation of the State registration of medicines supplied by the drug manufacturer or authorized person in accordance with this Federal Act. The law is the law of the authorized federal executive body until March 1, 2011, without the requirement of payment of the state duty under the laws of the Russian Federation on taxes and duties. 3-3. Decision to amend the records of the registered pharmaceutical drug for medical use and submitted prior to the date of entry into force of this Federal Law and to make a decision on the amendment of the documents in the registration file of the registered drug for medical use and submitted for the examination of medicines before the day of the entry into force of this Federal Law, on the basis of documents and data submitted prior to the day The entry into force of this Federal Act, as well as applications for amendments to the records of the registered pharmaceutical drug submitted by the manufacturer under this Federal Law to the authorized federal executive authority until 1 March 2011, without the requirement of payment of the State duty prescribed in OF THE PRESIDENT OF THE RUSSIAN FEDERATION 3-4. Permits for clinical studies of medicinal products for applications submitted prior to the date of entry into force of this Federal Law, as well as on applications filed after the date of entry into force This Federal Act, on the basis of expert examinations carried out prior to the date of the entry into force of this Federal Act, shall be carried out in accordance with this Federal Law on the basis of documents and data submitted or received prior to the date of entry into force of the Act. of the present Federal Law, as well as on the basis of a copy of of the preliminary agreement of compulsory life insurance, the health of patients participating in the clinical study of the medical drug for medical use, or a copy of the contract of compulsory life insurance, patients ' health, participating in a clinical trial for medical treatment, or a copy of the compulsory insurance contract entered into in accordance with the model rules for compulsory insurance, with an indication of the limit number of patients in clinical trial Medical treatment for medical use, without the requirement of the payment of the state duty under the Russian Federation's legislation on taxes and fees. "; b) Part 3-7 should be set out in the following wording: " 3-7. After 1 March 2011, the manufacture and importation into the territory of the Russian Federation of medicinal products in packages marked on the date of the entry into force of this Federal Law shall not be allowed. At the end of this period, the medication may be released, sold, transferred and used before their expiry date. "; in) to be supplemented with Part 7, reading: " 7. Formation of a State task of carrying out expert examination of medicines to the Federal State Budget Agency for carrying out the expert examination of medicines and financial support for the implementation of this task is carried out in the Procedure established by the Federal Act of 12 January 1996 No. 7-FZ "On Non-Profit Organizations". Article 14 Article 14, paragraph 3 (a) of the Federal Law dated April 22, 2010 N 65-FZ "On amendments to the Law of the Russian Federation" On the organization of the insurance case in the Russian Federation " and certain legislative acts of the Russian Federation. 1988), to be deleted. Article 15 Amend the Federal Law of 8 May 2010 N 83-FZ " On amendments to selected pieces of legislation OF THE PRESIDENT OF THE RUSSIAN FEDERATION 2291), the following changes: 1) in article 30: (a) in Part 8, the words "shall be accounted for in a separate personal account of the budget institution" with the words " the means of compulsory health insurance provided by the said "(b) Part 16 is supplemented with the following sentence:" Expenses of the budgetary institutions whose financial security sources are compulsory Medical insurance coverage, carried out after inspection A body of the Federal Treasury or the financial authority of the constituent entity of the Russian Federation (municipality) conducting the opening and maintenance of a separate account of the budget institution opened to account for the transactions with these funds; correspondence of the contents of the operation to the classification codes of the operations of the public administration sector specified in the payment documents of the budgetary institutions. "; 2), to supplement article 31 with parts 18 and 19 as follows: " 18. In 2011 and 2012, the financial support provided by the federal budget for health care provided by the basic compulsory health insurance programme in the federal budget institutions is being implemented in the form of Article 78, paragraph 1, of the Budget Code of the Russian Federation. 19. State institutions of the constituent entities of the Russian Federation and municipal institutions involved in the implementation of compulsory health insurance schemes cannot be established in the form of government agencies. ". Article 16 1. Admit invalid as of 1 January 2011: 1) paragraph 4 (p) of paragraph 1 and article 5, paragraph 4, subparagraph 2, of the Federal Law dated August 8, 2001 N 129-FZ "On State Registration of Legal Persons and Individual Entrepreneurs" (Legislative Assembly of the Russian Federation, 2001, N 33, Art. 3431; 2003, N 52, sect. (5037); 2) paragraph 12 of subparagraph (a) and article 6 (1) (b) of the Federal Law of 23 December 2003 N 185-FZ "On amendments to legislative acts of the Russian Federation in terms of improving procedures of state registration and registration of legal entities and individual entrepreneurs" (Legislative Assembly of the Russian Federation) Federation, 2003, N 52, sect. 5037). 2. Admit invalid since 1 January 2012: 1) paragraphs 5 and 6 of Article 1 of Federal Law of 29 December 2004 N 204-FZ "On amendments to Part 2 of the Tax Code of the Russian Federation" (Assembly of Laws of the Russian Federation, 2005, N 1, Art. 30); 2) Paragraph 5 of Article 15 (8) of the Federal Law of December 29, 2006, N 258-FZ " On amendments to certain OF THE PRESIDENT OF THE RUSSIAN FEDERATION 21); 3) Article 26, paragraphs 7 and 9, of the Federal Law of 18 October 2007, No. 230FZ " On amendments to selected legislative acts OF THE PRESIDENT OF THE RUSSIAN FEDERATION Article 1, paragraph 2 (b), of the Federal Law of 16 October 2010, "On Amendments to the Federal Law" On Amendments to the Federal Law on Amendments to the Law of the Republic of Contributions to the Pension Fund of the Russian Federation, the Russian Federation Social Insurance Fund, the Federal Compulsory Medical Insurance Fund and the territorial funds of compulsory health insurance, and article 33 of the Federal Law "On compulsory pension insurance in the Russian Federation" OF THE PRESIDENT OF THE RUSSIAN FEDERATION 5294. Article 17 1. This Federal Act shall enter into force on 1 January 2011, with the exception of the provisions for which this article establishes a different period of entry into force. 2. Paragraphs 1, 2, subparagraph "d" of paragraph 5, paragraph 6, subparagraphs (a) and (c), of article 13, paragraph 10, of this Federal Act shall enter into force on the date of its official publication. 3. Article 1, paragraph 2, article 4, paragraph 1, subparagraph (b), paragraph 1, article 6, paragraph 2, articles 7 and 9, paragraphs 1-3, 5 to 9 and article 12, paragraph 10 (a), of article 15, paragraph 1, of this Federal Law shall enter into force on 1 January 2012. 4. Article 17, part 3, article 29, paragraph 6, article 71, paragraphs 3-1-3-4 of the Federal Law of 12 April 2010, No. 61-FZ " On appeal " (in the wording of this Federal Law) applies to the legal relations that have arisen since 1 September 2010. 5. In 2011, the authorities of the constituent entities of the Russian Federation, in coordination with local authorities, are entitled to organize the provision of medical assistance in the territory of the constituent entities of the Russian Federation in accordance with the territorial jurisdiction of the Russian Federation. Programme of State guarantees for the provision of free medical assistance to citizens of the Russian Federation (except for medical assistance provided in federal medical facilities, the list of which is approved by the Government Commissioner) OF THE PRESIDENT OF THE RUSSIAN FEDERATION President of the Russian Federation Dmitry Medvedev Moscow, Kremlin November 29, 2010 N 313-FZ