Why you should buy this report

This report is a single point solution to study end-to-end regulations imposed on Traditional medicines in Japan which has a boosting herbal medicinal products market

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

Summary
  • Provides the definition of traditional medicinal products and their governing regulations;
  • Carefully explains the information on product registration process;
  • Illustrates the process of registration with flow chart;
  • 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 for the traditional products to be imported in to Japan;
  • 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;
  • Provides information on labeling, advertising and claims of traditional medicines; and
  • Provides the permissible limits of contaminants;
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY 
  3. DEFINITION 1
  4. GOVERNING REGULATIONS 1
  5. IMPORT REQUIREMENTS
    1. Traditional Medicines Manufacturer's License
    2. Import Permit
      1. Documents Required
    3. Import Declaration
      1. Process
      2. Documents Required
    4. Fees and Timeline
  6. PRODUCT REGISTRATION
    1. Process
    2. Documents Required
    3. Validity
    4. Fee and Timeline
    5. Submission Mode:
  7. RENEWAL
    1. Documents Required:
    2. Renewal Process, Fee and Timeline:
  8. VARIATIONS
    1. Documents for Variation Application:
    2. Process, Fee and Timeline:
  9. LOCAL AGENT REQUIREMENTS
  10. INGREDIENTS
    1. Prohibited Ingredients
  11. CONTAMINANTS 7
  12. QUALITY AND SAFETY 8
  13. SAMPLES FOR ANALYSIS 7
  14. LABELING 7
    1. General Labeling
    2. Nutritional Labeling
  15. CLAIMS 7
    1. Nutrient Function Claims
  16. ADVERTISING
  17. WAREHOUSING
    1. Warehouse Classification in Japan
    2. Classifications of Business Warehouse
  18. REFERENCES
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