Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 33. State Register of Medicines
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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 33. State Register of Medicines
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 33. State Register of Medicines
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 33. State Register of Medicines

1. The state register of medicines contains the list of medicinal products which passed state registration, the list of pharmaceutical substances included in the composition of medicinal products and the following information:

1) with respect to medicinal products:

a) name of the medicinal product (international nonproprietary or chemical name of and trade name);
b) dosage form with indication of dosage rate of the medicinal product and its quantity in consumer package;
c) name of developer of the medicinal product;
d) name and addresses of the manufacturer of the medicinal product;
e) pharmacotherapeutic group of the medicinal product;
f) indications and contraindications for use of the medicinal product;
g) side effects of the medicinal product;
h) shelf life of the medicinal product;
i) storage conditions for the medicinal product;
j) dispensing conditions for the medicinal product;
k) number of pharmacopoeia monograph and, failing the latter, of normative documentation or normative document;
l) date of state registration of the medicinal product and registration number thereof and;

2) with respect to pharmaceutical substances:

a) name of the pharmaceutical substance (nonproprietary or chemical name of and trade name);
b) name and address of the manufacturer of the pharmaceutical substance;
c) shelf life of the pharmaceutical substance;
d) storage conditions for the pharmaceutical substance;
e) number of the pharmacopoeia monograph and, failing the latter, of normative documentation or normative document.

2. A pharmaceutical substance not used in the manufacturing of medicinal products may be included in the state register of medicines on the basis of the developer’s application, or manufacturer of the medicine, or a legal entity authorized by any of them, provided that the pharmaceutical substance was duly evaluated for quality as prescribed in article 34 of this Federal Law.

3. The procedure for maintenance of the state register of medicines intended for medical use and the procedure for maintenance of the state register of medicines intended for veterinary use shall be approved by the relevant authorized federal executive body.

 



 
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