Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 14. Principles of Expert Examination of Medicines and Ethical Expert Examination
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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 14. Principles of Expert Examination of Medicines and 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 14. Principles of Expert Examination of Medicines and 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
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Article 14. Principles of Expert Examination of Medicines and Ethical Expert Examination

1. Expert examination of medicines and ethical expert examination are based on the principles of legality, observance of human and citizen rights and freedoms, legal entity rights, expert independence, objectiveness, comprehensiveness and completeness of the trials conducted using the latest achievements of science and technology, responsibility of the federal state-financed institution for carrying out expert examination of medicines and responsibility of experts for performance and quality of expert examination.

2. Expert examination of medicines is carried out on a staged basis:

1) first stage: expert examination of documents submitted to obtain a permit to conduct a clinical trial of a medicinal product, excluding:

a) medicinal products permitted for medical use in the Russian Federation for over twenty years, for which bioequivalence study can not be conducted;
b) medicinal products for medical use for which international multicentre clinical trials have been conducted, partially on the territory of the Russian Federation;

2) second stage: expert examination of proposed methods of a medicine quality control, expert examination of the quality of medicine samples submitted using those methods (hereinafter – the “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 the medicinal product carried out after its clinical trial has been conducted.

3. Expert examination of medicines for veterinary use is carried out on a one stage basis and involves 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.

 



 
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