Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use
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Главная Documents Medical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use
Article Index
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products
Article 13. State Registration of Medicinal Products
Article 14. Principles of Expert Examination of Medicines and Ethical Expert Examination
Article 15. Federal State-Financed Institution Carrying Out Expert Examination of Medicines
Article 16. Organization of Expert Examination of Medicines for State Registration Thereof
Article 17. Ethical Expert Examination
Article 18. Submission and Review of Applications for State Registration of Medicinal Products and Submission of Necessary Documents
Article 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council
Article 20. Expert Examination of Documents Necessary to Obtain Permit for Conduct of Clinical Trial of Medicinal Product for Medical use and Ethical Expert Examination
Article 21. Procedure for Obtaining Permit to Conduct Clinical Trial of Medicinal Product for Medical use
Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use
Article 23. Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Medical use
Article 24. Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Veterinary Use
Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
Article 26. Accelerated Procedure for Expert Examination of Medicines
Article 27. Decision on State Registration of a Medicinal Product
Article 28. Registration Certificate for a Medicinal Product
Article 29. Confirmation of State Registration of a Medicinal Product
Article 30. Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Medical Use
Article 31. Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Veterinary Use
Article 32. Cancellation of State Registration of a Medicinal Product
Article 33. State Register of Medicines
Article 34. Quality Evaluation of Pharmaceutical Substance not used in Manufacturing of Medicinal Products
Article 35. Repeated Presentation of a Medicinal Product, which Failed State Registration of Medicinal Products for State Registration of Medicinal Products
Article 36. Appeal of Decision on Refusal to Issue Permit for Clinical Trials of Medicinal Product, or Refusal to Perform State Registration of a Medicinal Product
Article 37. Information Relating to State Registration of Medicinal Products, Information about Registered Medicinal Products, and Medicinal Products Removed from the Sate Register of Medicines
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Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use

1. To obtain a permit to conduct a clinical trial of a medicinal product for medical use, the applicant shall submit to the authorized federal executive body:

1) application for issuance of a permit to conduct such clinical trial;
2) information on the researchers’ experience in the relevant fields and in conducting clinical trials;
3) the copy of contract of compulsory insurance of the life and health of a patient involved in clinical trials of medicinal products for medical use (hereinafter “the contract of compulsory insurance”), made in accordance to the standard rules for compulsory life and health insurance of a patient involved in clinical trials of medicinal products for medical use approved by the Government of the Russian Federation (hereinafter “the standard rules for compulsory insurance”), with specifying the maximal number of patients involved in clinical trial of medicinal products for medical use ;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
4) the details of medical organizations which are scheduled to conduct clinical trials of  medicinal product for medical use (full and brief names of medical institution, legal form of medical institution, the seat and business location of medical institution, telephone, telefax, email address);
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
5) estimated terms of the clinical trial of the medicinal product for medical use.
(sub-clause 5 introduced by Federal Law of October 11, 2010, No. 271-FZ)

2. Within the period not exceeding five business days from the date of receipt of the application specified in Clause 1 of this article together with necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take decision on issuance of a permit to conduct the clinical trial of the medicinal product for medical use, or on refusal to issue such permit;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal;
4) issue a permit to conduct the clinical trial of the medicinal product for medical use in the manner prescribed by the authorized federal executive body.

3. Failure to submit the documents specified in Clause 1 of this article, or non-compliance of the documents submitted with the requirements of this Federal Law, or the presence of the conclusion issued by the expert institution or the conclusion issued by the Ethical council on impossibility of conducting of clinical trial of a medicinal product for medical use on the base of results of performed expert examinations provided for in Article 20 of this Federal law is considered grounds for refusal to issue a permit to conduct the clinical trial of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

 



 
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