Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 29. Confirmation of 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 29. Confirmation of 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 29. Confirmation of 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
All Pages

Article 29. Confirmation of State Registration of a Medicinal Product

1. Confirmation of state registration of a medicinal product shall be carried out when issuing a permanent registration certificate for the medicinal product in the case specified in Clause 2 of Article 28 hereof, within the period not exceeding ninety business days from the date of receipt of an application for confirmation of state registration of the medicinal product executed in accordance with Clause 2 of Article 18 hereof.

2. Confirmation of state registration of a medicinal product is carried out based on the results of expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3. The document certifying payment of the state duty for confirmation of state registration of the medicinal product for medical use or the medicinal product for veterinary use, and the document containing the results of safety monitoring of the medicinal product conducted by the applicant, executed as prescribed by the relevant authorized federal executive body, shall be enclosed with the application for confirmation of state registration of the medicinal product. Normative documentation or normative document, draft instructions for use of the medicinal product, draft designs of primary packages and secondary (retail) packages for the medicinal product shall be enclosed with the application for confirmation of state registration of the medicinal product again only in the case of amendments to them.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

4. Within ten business days upon the date of receipt of an application for confirmation of state registration of a medicinal product and necessary documents, the relevant authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) make a decision on whether to carry out or refuse carrying out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
3) notify the applicant in writing of the positive decision or, in case of refusal to carry out expert examination, of the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive information which shall be reflected therein is considered grounds for refusal to carry out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product and (or) expert examination of the quality of the medicinal drug.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. Expert examination of the quality of the medicine and (or) expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for the purpose of confirmation of state registration of a medicinal product shall be carried out based on the documents specified in Clause 3 of this Article, in the manner prescribed in Clauses 5 - 8 of Articles 23 and 24 hereof.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

7. While the procedure of confirmation of state registration of a medicinal product is on, civil circulation thereof is conducted within the territory of the Russian Federation.

 



 
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