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Why you should buy this report

This report is a single point solution to study end-to-end regulations imposed on traditional medicines in Vietnam, 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 Vietnam, so as to enable a Regulatory go-to-market strategy and ensure compliance.

Summary
  • Underlines the regulations that govern traditional medicines in Vietnam;
  • Provides information on product registration, applicable fees and timeline;
  • Outlines the submission mode of 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. PRODUCT REGISTRATION
    1. Registration Process
    2. Documents Required for Product Registration
    3. Mode of Dossier Submission
      1. Direct Submission at the DAV
      2. Submission by Mail
    4. Product Registration Fee
    5. Timeline
    6. Validity
  6. IMPORT REQUIREMENTS
    1. Company Registration

      1. Documents Required for Registration of an Enterprise/ Company
      2. Issuance of Enterprise Registration Certificate
      3. Fee for Company Registration
    2. Import Permit
      1. Documents for Import Permit
      2. Import Process
      3. Import Fee
  7. RENEWAL/ EXTENTION OF MARKET AUTHORIZATION
    1. Documents
    2. Process and Timeline
  8. VARIATION
    1. Documents Required
    2. Process, Fee and Timeline
  9. LOCAL AGENT REQUIREMENTS
    1. Qualifications of an Importer
    2. Responsibilities of an Importer
    3. Qualifications of a Distributor
    4. Requirements and Responsibilities of a QA Representative
  10. INGREDIENTS
    1. New Ingredient Registration 
  11. CONTAMINANTS
  12. LABELING
    1. Content of Labels
    2. Size of the Label, Font Color, Symbols and Images on Label
    3. Language Inscribed on the Drug Label
  13. QUALITY AND SAFETY
  14. SAMPLES FOR ANALYSIS
  15. DRUG ADVERTISING 
  16. CLAIMS
  17. WAREHOUSE
  18. REFERENCES
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