Why you should buy this report

This report is a single point solution to study end-to-end regulations imposed on traditional medicines in South Korea. Korean traditional medicine is a longstanding and integral part of Korean cultural heritage. Hence the growth of herbal markets has increased substantially in South Korea.

The objective of this report is to provide precise information on the Regulatory landscape of South Korea, 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;
• 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 in to 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.

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. 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 3
   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 1
12. QUALITY AND SAFETY
13. LABELING
14. CLAIMS AND ADVERTISING  
15. WAREHOUSING
16. REFERENCES

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