Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - 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
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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 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
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - 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 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 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

1. Expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product for medical use, generation of conclusions by the expert councils based on the results of clinical trials and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding one hundred and ten business days from the date of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body together with the documents specified in Sub-clauses 1 – 8 and 15 - 17 of Clause 3 of Article 18 hereof and a report on the clinical trial of the medicinal product for medical use conducted.

2. For the purpose of expert examinations specified in Clause 1 of this article, the applicant shall submit to the authorized federal executive body:

1) application for renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article;
2) report on the clinical trial of the medicinal product for medical use conducted;
3) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use when applying for state registration.

3. Within the period not exceeding five business days from the date of receipt of the application together with the documents specified in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, the authorized body shall:

1) examine the data contained in the report on clinical trial of the medicinal product for medical use submitted by the applicant for completeness and reliability;
2) take decision on renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article, or on refusal to renew state registration of the medicinal product and carry out such expert examinations;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

4. Failure to submit a complete set of the documents listed in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, or submission of the report on the clinical trial of the medicinal product for medical use lacking a comprehensive list of necessary information is considered grounds for refusal to renew state registration and carry out expert examinations specified in Clause 1 of this article.

5. Within fifteen business days from the date of receipt of the decision on renewal of state registration of the medicinal product and performance of expert examinations specified in Clause 1 of this article, issued by the authorized federal executive body, the applicant shall submit samples of the medicine product for medical use manufactured in compliance with the requirements of the experimental industrial regulations and (or) industrial regulations approved by the head of the medicines manufacturing company, as well as, in appropriate cases, sample of the pharmaceutical substance, test strain of microorganisms, cultured cells, samples of substances used for quality control of a medicinal product be means of comparison of a medicinal drug to them, in the quantities necessary to reproduce the quality control methods, for the purpose of expert examination of the quality of the medicinal product.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. On receipt of samples of a medicinal product and pharmaceutical substance the expert institution shall provide the applicant with a document certifying the receipt of such samples, and notify the authorized executive body thereof in writing within the period not exceeding three business days.

7. The period of submission of samples of a medicinal product and pharmaceutical substance by the applicant and the period of a written notification thereof of the authorized federal executive body by the expert institution specified in Clauses 5 and 6 of this article are not included in the period of performance of expert examinations specified in Clause 1 of this article.

8. The documents submitted to the expert institution for performance of expert examinations specified in Clause 1 of this article are subject to return to the authorized federal executive body concurrently with the conclusions based on the results of such expert examinations.

 



 
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