Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 27. Decision on State Registration of a Medicinal Product
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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 27. Decision on State Registration of a Medicinal Product
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 27. Decision on State Registration of a Medicinal Product
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 27. Decision on State Registration of a Medicinal Product

1. Within the period not exceeding five business days from the date of receipt of the conclusions issued by the expert commission based on the results of 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 the relative authorized federal executive body shall:

1) evaluate such conclusions in order to determine compliance thereof with the assignment for performance of such expert examinations;
2) take a decision on whether to approve state registration of the medicinal product or to refuse approving state registration of the medicinal product;
3) in case of a positive decision on state registration of the medicinal product, enter the data on the registered medicinal product, including, but not limited to the data on the pharmaceutical substance contained in the medicinal product, into the state register of medicines and issue to the applicant a registration certificate, the form of which is to be approved by the authorized federal executive body, approved normative documentation, the normative document, Package Leaflet for the medicinal product and designs of the primary and secondary (retail) packages bearing the number of the registration certificate for the medicinal product and the date of state registration thereof or, in case of refusal of state registration of the medicinal product, notify the applicant in writing of the grounds for such refusal;

2. Decision of the relevant authorized federal executive body stating that the data obtained do not confirm quality and(or) efficacy of the medicinal product to be registered, or possible health hazard to human beings and animals taking the medical product exceeds the efficacy thereof is considered grounds for refusal of state registration of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

3. When registering a medicinal product included in the list of vital and essential medicinal products, necessary data shall be entered into the state register of maximum ex-works manufacturers’ prices for the medicinal products included in such list.

 



 
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