Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council
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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 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council
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 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council

1. Within five business days from on receipt of an application for state registration of a medicinal product, the authorized federal executive body shall review the data contained in the materials submitted by the applicant for completeness and reliability, and take decision on issuance of an assignment to carry out:

1) expert examination of the medicines, in particular expert examination of the documents submitted to obtain a permit for the conduct of a clinical trial of the medicinal product for medical use in accordance with the objectives specified in Article 38 hereof, and ethical expert examination with respect to the medicinal products, for which clinical trials have not been conducted within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9, 11 – 14 and 17 of Clause 3 and Sub-clause 1 of Clause 5 of Article 18 hereof;
2) expert examination of the medicines, in particular expert examination of the quality of the medicines and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use with respect to the medicinal products permitted for use within the territory of the Russian Federation for over twenty years, based on the documents specified in Sub-clauses 1 – 9 and 16 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof, as well as the medicinal products, for which international multicentre clinical trials have been conducted, partially within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9 and 15 - 17 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof;
3) expert examination of the medicine with respect to the medicinal products for veterinary use, based on the documents specified in Sub-clauses 1 – 8, 10, Items a-e, g-l and o-t of Sub-clause 16 and Sub-clause 17 of Clause 3 and Sub-clause 4 of Clause 5 of Article 18 hereof.

2. The authorized federal executive body notifies the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

3. Failure to submit a complete set of the documents listed in Clauses 3 and 5 of Article 18 hereof necessary for performance of expert examinations, or submission of documents lacking a comprehensive list of necessary information is considered grounds for refusal to carry out expert examinations specified in Clause 1 of this Article.

 



 
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