Why you should buy this report

This report is a single point solution to study end-to-end regulations imposed on traditional medicines in Russia, where traditional medicines have become more popular due to the higher awareness amongst the consumers about health and wellness.

The objective of this report is to provide precise information on the Regulatory landscape of traditional medicines in Russia, so as to enable a Regulatory go-to-market strategy and ensure compliance.

Summary
  • Underlines the regulations that govern traditional medicines in Russia;
  • Provides information on product registration, applicable fees and timeline;
  • Outlines the submission mode of the dossier;
  • Provides information on validity, renewal and variations;
  • Furnishes the regulations of import that are levied on traditional medicines;
  • Includes precise information on the qualification and requirements of a legal representative;
  • Provides information on the list of ingredients which are approved and restricted from use in traditional medicines;
  • Details the regulations imposed on labeling of traditional medicines;
  • Includes information on quality and safety that should be maintained while handling traditional medicines;
  • Furnishes the regulations on advertisement content and its scope; and
  • Provides information on warehousing requirements for traditional medicines.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY
  3. DEFINITION
  4. GOVERNING REGULATIONS     
  5. IMPORT REQUIREMENTS
    1. Import Process
    2. Documents for Import Permit
    3. Fee and Timeline
    4. Company Registration
      1. Limited Liability Company
      2. Individual Entrepreneur
  6. PRODUCT REGISTRATION
    1. Documents Required
      1. Part I: Administrative
      2. Part II: Quality Documentation
      3. Part III: Pharmacological and Toxicological Documentation
      4. Part IV: Clinical documentation
    2. Submission Mode
    3. Fee and Timeline
  7. VALIDITY AND RENEWAL
    1. Documents Required
    2. Renewal Process, Fee and Timeline
  8. VARIATIONS
    1. Documents for Variation Application
    2. Process of Variation Application
    3. Fee and Timeline
  9. LOCAL AGENT REQUIREMENTS
    1. Qualifications of an Importer/ Distributor
    2. Responsibilities of an Importer/ Distributor
    3. Qualification and Responsibilities of a Sanitary Responsible person
  10. INGREDIENTS
    1. Permitted and Prohibited Ingredients
    2. New Ingredient Registration
  11. CONTAMINANTS
  12. QUALITY AND SAFETY 
  13. SAMPLES FOR ANALYSIS
  14. LABELING
  15. ADVERTISING
  16. CLAIMS
  17. WAREHOUSING
  18. REFERENCES
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