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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.

Table of Contents
Summary
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  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY
  3. DEFINITION
  4. GOVERNING REGULATIONS
  5. IMPORT REQUIREMENTS
    1. Import Process
    2. Documents for Import Permit
    3. Timeline
  6. PRODUCT REGISTRATION
    1. Documents Required
      1. Module I: Administrative
      2. Module II: Overview and Summaries
      3. Module III: Quality
      4. Module IV: Nonclinical Study Reports
      5. Module V: Clinical Study Reports
    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. Importer’s Requirement
    2. Qualifications and Responsibilities of an Importer
    3. Distributor’s Requirements
    4. Sanitary Responsible Person
  10. INGREDIENTS
    1. Prohibited Ingredients
    2. New Ingredient Registration
      1. Process of Registration
      2. Fees and Timeline
  11. CONTAMINANTS
  12. QUALITY AND SAFETY
  13. LABELING
  14. CLAIMS AND ADVERTISING
  15. WAREHOUSING
  16. REFERENCES
  • Provides the definition of traditional medicinal products and their governing regulations;
  • Carefully explains the information on product registration process;
  • Elaborates the documentation with modules;
  • Precise information on health authority fees, timelines for registration and submission modes (online/in person);
  • Additional information on validity of the registration, renewal process and variation filing;
  • Details the import regulations and custom clearance requirements for the traditional products to be imported into South Korea;
  • Highlights the process of import clearance through flow chart;
  • Enables to understand about the minute points like qualification of the importer, local agent requirements, etc.;
  • Details the information of quality, safety and warehousing;
  • Lists the ingredients which is crucial to check the components of the products without getting the product being rejected by the regulating authority;
  • Includes the information of new ingredient registration process in South Korea;
  • Precise details on fee and timeline for ingredient registration;
  • Provides information on labeling, advertising and claims of traditional medicines; and
  • Provides the permissible limits of contaminants.
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