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Appendix E
Regulations Regarding the Federal Service for the Supervision in the Sphere of Health and Social Development1

RESOLUTION

Of June 30, 2004, No. 323

Moscow


On approval of the Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development.


(including amendments of August 12, 2004)


The Government of the Russian Federation hereby resolves:

  1. To approve the attached Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development.

  2. That the Ministry of Health and Social Development of the Russian Federation shall submit to the Government of the Russian Federation, by October 1, 2004, draft normative legal acts for the purpose of repealing excessive powers provided by sub-paragraphs 6.8 and 6.9 of the Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development.

Chairman of the Government of the Russian Federation M. Fradkov

1  

Translated from the Russian by Supernova Translations.com.



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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Appendix E Regulations Regarding the Federal Service for the Supervision in the Sphere of Health and Social Development1 RESOLUTION Of June 30, 2004, No. 323 Moscow On approval of the Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development. (including amendments of August 12, 2004) The Government of the Russian Federation hereby resolves: To approve the attached Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development. That the Ministry of Health and Social Development of the Russian Federation shall submit to the Government of the Russian Federation, by October 1, 2004, draft normative legal acts for the purpose of repealing excessive powers provided by sub-paragraphs 6.8 and 6.9 of the Regulations regarding the Federal Service for Supervision in the Sphere of Health and Social Development. Chairman of the Government of the Russian Federation M. Fradkov 1   Translated from the Russian by Supernova Translations.com.

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security APPROVED By Resolution of the Government of the Russian Federation on June 30, 2004, No. 323 (including amendments of August 12, 2004) REGULATIONS On the Federal Service for Supervision in the Sphere of Health and Social Development. 1. General provisions The Federal Service for Supervision in the Sphere of Health and Social Development is a federal executive body which shall perform the functions of control and supervision in the sphere of Health and Social Development. The Federal Service for Supervision in the Sphere of Health and Social Development shall be established under the Ministry of Health and Social Development of the Russian Federation. The Federal Service for Supervision in the Sphere of Health and Social Development shall be guided in its activities by the Constitution of the of the Russian Federation, Federal Constitutional Laws, Federal Laws, normative legal acts issued by the President of the Russian Federation, normative legal acts issued by Ministry of Health and Social Development of the Russian Federation, and by these Regulations. The Federal Service for Supervision in the Sphere of Health and Social Development shall carry out its activities directly, as well as through its territorial branches, and through interaction with other federal executive bodies, executive bodies of the Subjects of the Federation, local governments, public associations and other organizations. 2. Powers 5. The Federal Service for Supervision in the Sphere of Health and Social Development [henceforth “the Service”] shall have the following powers: 5.1. the Service shall: 5.1.1. supervise: 5.1.1.1. pharmaceutical activities; 5.1.1.2. in observance of state standards and technical specifications for products intended for medical use;

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 5.1.2. control and supervise the observance of state standards in social services; 5.1.3. control: 5.1.3.1. procedures for conducting medical examinations; 5.1.3.2. procedures for determining the extent of professional disability resulting from employment injury or occupational disease; 5.1.3.3. procedures for organizing and conducting medical examinations, as well as rehabilitation of the disabled; 5.1.3.4. performance of medico-legal and medico-psychiatric examinations; 5.1.3.5. production, manufacture, quality, effectiveness, safety, sale, and use of medications; 5.1.3.6. production, sale, and use of products intended for medical purposes; 5.1.3.7. preclinical and post-clinical research of medications, as well as observance of good laboratory and clinical practices; 5.1.3.8. observance of quality standards in rendering medical assistance; 5.2. the Service shall organize examinations of quality, effectiveness and safety of medications; Pursuant to the Resolution of the Government of the Russian Federation of August 12, 2004 No. 412, paragraph 5.3 of these Regulations has been amended. 5.3. the Service shall issue: 5.3.1. licenses for conducting: 5.3.1.1. medical activities; 5.3.1.2. pharmaceutical activities; See Order of The Federal Service for Supervision in the Sphere of Health and Social Development of July 13, 2004 No. 6-Pr/04 on the creation of the Central Commission of the Federal Service for Supervision in the Sphere of Health and Social Development for licensing of pharmaceutical activities. 5.3.1.3. activities relating to the provision of artificial limbs and orthopedic assistance; 5.3.1.4. activities relating to the production of medications, with the exception of medications intended for animals and medicated feed supplements; 5.3.1.5. activities relating to the production of medical equipment; 5.3.1.6. activities relating to the turnover of narcotic drugs and psychotropic substances (development, production, manufacture, processing, storage, transportation, measuring out, handling, distribution, pur-

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security   chase, use, and disposal) included in List II pursuant to the Federal Law On Narcotic Drugs and Psychotropic Substances; 5.3.1.7. activities relating to the trade in psychotropic substances (development, production, manufacture, processing, storage, transportation, measuring out, handling, distribution, purchase, use, and disposal) included in List III pursuant to the Federal Law On Narcotic Drugs and Psychotropic Substances; 5.3.2. permits for: 5.3.2.1. use of new medical technologies; 5.3.2.2. import of medications (provided they are medications intended for medical purposes) to the territory of the Russian Federation in accordance with procedures established by the legislation of the Russian Federation; 5.3.2.3. export of medications (provided they are medications intended for medical purposes) from the territory of the Russian Federation in accordance with procedures established by the legislation of the Russian Federation; 5.3.2.4. import to the territory of the Russian Federation of unregistered medications for the purpose of conducting their clinical tests; 5.3.2.5. conducting clinical tests of medications; 5.4. the Service shall issue to organizations producing certificates of compliance for medications with the requirements set by the legislation of the Russian Federation in the process of licensing the production of medications; Pursuant to the Letter of the Federal Service for Supervision in the Sphere of Health and Social Development of August 20, 2004 No. 2174/04, the system of state control of quality, effectiveness and safety of medications shall not envisage any mandatory forms of proof of conformity for medications outside of state control. 5.5 the Service shall register: 5.5.1. caps on selling prices of vitally important and essential medications in accordance with procedures established by the legislation of the Russian Federation; 5.5.2. medications and products intended for medical purposes; 5.6. the Service shall maintain: 5.6.1. a state register of medications; 5.6.2. a state register of vitally important and essential medications;

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 5.6.3. a list of health institutions which have the right to conduct clinical tests of medications; 5.7. the Service shall conduct performance reviews and certification of specialists dealing with medications; 5.8. the Service shall carry out, pursuant to established procedures, inspections of health institutions, drug stores, wholesalers of medications, social protection organizations, and other organizations and individual entrepreneurs engaged in the sphere of health and social protection of the population; 5.9. the Service shall perform the functions of the main agent for the disposal and receipt of Federal Budgetary funds earmarked for financing the maintenance of the Service and its operations aimed at achieving its statutory functions; 5.10. the Service shall, within its powers, protect information which constitutes a state secret; 5.11. the Service shall provide visiting hours for individuals, ensure timely consideration of their petitions, make decisions regarding these petitions and forward replies to petitioners within the time frames established by the legislation of the Russian Federation; 5.12. the Service shall ensure readiness of the Service for mobilization, and shall control and coordinate such readiness in all organizations under its supervision; 5.13. the Service shall conduct professional training of its staff, maintenance training, refresher courses and traineeship; 5.14. the Service shall, pursuant to the legislation of the Russian Federation, carry out the filing, storage, recording and use of archival documents resulting from the operations of the Service; 5.15. the Service shall, in accordance with the established procedure, maintain relations with government agencies in other countries and international organizations in the specified sphere of activity; 5.16. the Service shall, in accordance with the established procedure, conduct tenders and sign government contracts for the placement of orders for shipment of goods, performance of work, provision of services for the needs of the Service, as well as for scientific research and development intended to meet the needs of the State in the specified sphere of activity; 5.17. the Service shall perform other functions in the specified sphere of activity, provided such functions are envisaged by Federal laws, normative legal acts issued by the President of the Russian Federation or the Government of the Russian Federation;

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 6. The Federal Service for Supervision in the Sphere of Health and Social Development shall, for the purpose of exercising its powers in the specified sphere of activity, have the right to: 6.1 organize the necessary research, tests, examinations, analysis and estimates, as well as scientific research pertaining to carrying out supervision in the specified sphere of activity; 6.2. request and receive information necessary for decision-making on issues within the competence of the Service; 6.3. provide explanations to legal entities and physical persons on issues within the competence of the Service; 6.4. exercise control over the operations of territorial branches of the Service and organizations under its supervision; 6.5. attract, in accordance with the established procedure, scientific and other organizations, academics and specialists for joint work on issues pertaining to the specified sphere of activity; 6.6. obtain free access to any enterprise producing medications and obtain samples of the medications produced in accordance with the procedure established by the legislation of the Russian Federation; 6.7. make copies of documents necessary to control the production and quality of medications in accordance with the procedure established by the legislation of the Russian Federation; 6.8. ban production of medications and sale of stocks of already produced medications in cases listed in the Rules for the Organization of Production and Control of Quality of Medications, in accordance with the procedure established by the legislation of the Russian Federation; 6.9. ban advertisement of medications and appraise the advertiser of the necessity to amend the advertisement of a medication in cases envisaged by the legislation of the Russian Federation, in accordance with the procedure established by the legislation of the Russian Federation; 6.10. apply restrictive, preventive, and prophylactic measures envisaged by the legislation of the Russian Federation aimed at prevention and/or remediation of the consequences of a breach by legal entities or individuals of mandatory requirements in the specified sphere of activity, for the purpose of termination in instances of a breach of the legislation of the Russian Federation; 6.11. establish consultative and analytical bodies (councils, commissions, groups, colleges) in the specified sphere of activity; 7. The Federal Service for Supervision in the Sphere of Health and Social Development shall not have the right to carry out normative legal regulation in the specified sphere of activity, with the excep-

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security      tion of the cases which shall be determined by Decrees of the President of the Russian Federation and Resolutions of the Government of the Russian Federation, nor shall it engage in the management of public property or in the provision of paid services; The restriction of powers of the Service established in paragraph 1 of this provision shall not apply to the powers of the Head of the Service’s Property Management Service which has been granted operational management powers, powers to resolve personnel issues and organize the operations of the Service. III. Organization of Operations 8. The Head of the Federal Service for Supervision in the Sphere of Health and Social Development shall be appointed and dismissed by the Government of the Russian Federation on the recommendation by the Minister of Health and Social Development of the Russian Federation. The Head of the Federal Service for Supervision in the Sphere of Health and Social Development shall be personally responsible for the performance of the functions and achievement of goals of the Service. The Head of the Service shall have Deputies, appointed and dismissed by the Minister of Health and Social Development of the Russian Federation on the recommendation of the Head of the Service. The number of Deputy Heads of the Service shall be determined by the Government of the Russian Federation. 9. The Head of the Federal Service for Supervision in the Sphere of Health and Social Development shall: 9.1. allocate the functions among his Deputies; 9.2. submit to the Minister of Health and Social Development of the Russian Federation: 9.2.1. draft regulations for the Service; 9.2.2. provide suggestions on caps for the number of employees and the wage bill for the headquarters and territorial branches of the Service; 9.2.3. provide suggestions for the appointment and dismissal of Deputy Heads of the Service;

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Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 9.2.4. provide suggestions for the appointment and dismissal of Heads of the territorial branches of the Service; 9.2.5. provide annual draft action plans and projected performance indicators for the Service, as well as annual plan execution reports; 9.2.6. provide suggestions for the Draft Federal Budget, insofar as they pertain to the financing of the Service; 9.3. appoint and dismiss personnel employed at the headquarters of the Service and Deputy Heads of its territorial branches; 9.4. address, in accordance with the legislation of the Russian Federation on the government service, issues pertaining to performing government service in The Federal Service for Supervision in the Sphere of Health and Social Development; 9.5. approve the administrative chart and job specifications for the headquarters of the Service within the limits of labor laws and the number of employees established by the Government of the Russian Federation, as well as budget expenditures for the headquarters of the Service within the appropriations approved for the relevant period in the Federal Budget; 9.6. approve the number of employees and wage bills for territorial branches of the Service within targets established by the Government of the Russian Federation, as well as budget expenditures for these territorial branches within the appropriations approved for the relevant period in the Federal Budget; 9.7 in accordance with, and pursuant to, the Constitution of the Russian Federation, Federal Constitutional Laws, Federal Laws, Acts issued by the President of the Russian Federation and Ministry of Health and Social Development of the Russian Federation, issue orders pertaining to issues within the competence of the Service. 10. Financing of expenditures of the headquarters and territorial branches of the Federal Service for Supervision in the Sphere of Health and Social Development shall be provided from the appropriations made for this purpose in the Federal Budget. 11. The Federal Service for Supervision in the Sphere of Health and Social Development shall be a legal entity and shall have a seal with the National Emblem of the Russian Federation and with its name, other seals, stamps, and letterheads of established form, as well as accounts to be opened in accordance with the legislation of the Russian Federation. 12. The location of the Federal Service for Supervision in the Sphere of Health and Social Development shall be in Moscow.