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Why you should buy this report

This report is a comprehensive solution for studying end-to-end regulations on traditional medicines in Brazil. The objective of this report is to enable a Regulatory go-to-market strategy and ensure compliance.

Summary
  • Product registration process, documentation required, applicable fees and timelines
  • Submission mode of dossier
  • Provides information on validity of registration, renewal and variations
  • Regulations on import and custom clearance levied on traditional medicines in Brazil
  • Qualification and responsibilities of a legal representative
  • Provides information on the list of ingredients that are approved and restricted from use in traditional medicines
  • Regulations on labeling, advertising and claims
  • Warehousing requirements for traditional medicines
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY 
  3. DEFINITION
  4. GOVERNING REGULATIONS         
  5. NOTIFICATION
    1. Rules Governing the Simplified Notification of Traditional Phyto-therapeutic Product (PTF)
  6. PRODUCT REGISTRATION
    1. Process
    2. Presentation
    3. Documentation
      1. Administrative Documentation
      2. Technical Documentation
      3. Stability Study Report
      4. Production Report
      5. The Quality Control Report
      6. Safety Report and Efficacy / Effectiveness.
      7. Additional Requirements for Imported Products
  7. SUBMISSION MODE
  8. FEE AND TIMELINE 
  9. VALIDITY AND RENEWAL
    1. Renewal Fees
    2. Renewal Timeline
  10. VARIATIONS
    1. Procedure
    2. Documentation
    3. Fees
  11. IMPORT REQUIREMENTS
    1. Import License
    2. Import Modalities
      1. International Postal Shipment
      2. Express Shipping
      3. International Airline Order
      4. Integrated Foreign Trade System (SISCOMEX)
      5. Simplified Non-Electronic Import Declaration
    3. Documentation
    4. Procedure
      1. Import licensing registration through Siscomex
    5. Fees
      1. ANVISA Fee
    6. Validity and Renewal
  12. GOOD MANUFACTURING PRACTICES
    1. Quality management
  13. LOCAL AGENT REQUIREMENTS
    1. Qualifications & Responsibilities of Importer
    2. Qualifications & Responsibilities of the Distributor
  14. PROHIBITED and RESTRICTED PLANT SPECIES
  15. QUALITY AND SAFETY
  16. LABELLING
    1. Information on Secondary Packing
    2. The Information for Primary Packaging
    3. Optional Information:
    4. The Leaflet
    5. Information to be provided in the Brochure Product
      1. Identification of Traditional Herbal Medicine:
      2. Information on the Presentations and Composition:
      3. Patient Information
  17. CLAIMS AND ADVERTISEMENT
  18. WAREHOUSING 
  19. REFERENCES
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