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
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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 13. State Registration of Medicinal Products
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 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 13. State Registration of Medicinal Products

1. Medicinal products are put into civil circulation in the Russian Federation provided they have been registered with the relevant authorized federal executive body.

2. State registration is required for:

1) originator medicinal products;
2) generic medicinal products;
3) new combinations of previously registered medicinal products;
4) new dosage forms or new dosage rates of previously registered medicinal products.

3. State registration of medicinal products for medical use shall be carried out based on the results of expert examination of the medicines and ethical expert examination of the possibility of a clinical trial of the medicinal product for medical use (hereinafter – the “ethical expert examination”). State registration of medicinal products for veterinary use is carried out based on the results of expert examination of the medicines for veterinary use.

4. State registration of medicinal products shall be carried out by the relevant authorized federal executive body within the period not exceeding two hundred and ten business days upon filing an application for state registration of the medicinal product. The period specified above includes the time necessary to carry out repeated expert examination of the medicines and (or) repeated ethical expert examination in accordance with Article 25 hereof. The period of state registration of a medicinal product is calculated from the date of filing by the relevant authorized federal executive body of an application for state registration of the medicinal product together with required documents as enclosed to the date of issuance of the registration certificate for the medicinal product. The time spent on a clinical trial of the medicinal product is not considered when calculating the period of state registration.

5. No state registration is required for:

1) medicinal products compounded by pharmacy institutions, veterinary pharmacy institutions and individual entrepreneurs holding pharmaceutical licenses under medicinal product prescriptions and orders of medical institutions and veterinary institutions;
2) herbal medicinal raw materials;
3) medicinal products acquired by individuals outside the Russian Federation and intended for personal use;
4) medicinal products intended for export;
5) radiopharmaceutical medicinal products compounded directly in medical institutions in the manner prescribed by the authorized federal executive body.

6. State registration is forbidden for:

1) different medicinal products under the same trade name;
2) one and the same medicinal product manufactured by the manufacturer under different trade names and submitted for state registration as two or more medicinal products.

 



 
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