Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
Loading

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 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
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
All Pages

Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination

1. In case of insufficient feasibility or incompleteness of the conclusion issued by the expert institution or ethical council, presence of controversial data in such conclusion, falsification of the inferences based on the results of expert examination of a medicine and (or) ethical expert examination, concealment from the authorized federal executive body of any grounds for rejection of an expert due to his being interested in the results of the relevant expert examination, availability of data on direct or indirect interference in the expert examination procedure of any persons not participating in the performance thereof, however having influenced the procedure and the results thereof, the authorized federal executive body shall schedule repeated expert examination of the medicine and (or) repeated ethical examination.

2. Repeated expert examination of a medicine shall be carried out within the period prescribed by the authorized federal executive body, not exceeding forty business days from the date of receipt by the expert institution of an assignment to carry out repeated expert examination of the medicine; repeated ethical expert examination shall be carried out within the period not exceeding fifteen business days from the date of receipt by the ethical council of an assignment to perform repeated ethical expert examination.

3. Financing of repeated expert examination of a medicine is not provided, and the funds transferred for the performance of such expert examination earlier are subject to return to the federal budget.

 



 
More Info