Regulation of Traditional Medicines in Brunei

Why you should buy this report

This comprehensive report provides precise information on the regulations applicable to traditional medicine in Peru, so as to enable a Regulatory go-to-market strategy and ensure compliance.

Summary
  • Information on the approval or registration process;
  • Procedure for company registration in Brunei;
  • Covers details on documentation, fees required for submission, submission modes (online/in person), qualification of the importer, etc;
  • Provides a list of permitted/prohibited ingredients to check formulation compliance;
  • Lists out acceptable/unacceptable claims, labeling and advertising regulations;
  • Heavy metals and microbial contamination limits; and
  • Accommodates a brief on custom clearance process.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. INTRODUCTION
  3. DEFINITION
  4. IMPORT
    1. Company registration
    2. Registration
      1. Documents for Registration
      2. Registration Process
      3. Application Screening
      4. Application Evaluation
      5. Lead Time for Each Step
      6. Validity and Renewal 7
      7. Documents for Renewal
    3. Import Permit
  5. FEES FOR PRODUCT REGISTRATION AND RENEWAL
  6. VARIATIONS 7
    1. Types of Variations
    2. Application Form
    3. Documents for Variation Application
    4. Fees for Variation Application
  7. APPLICATION SUBMISSION
  8. LOCAL AGENT REQUIREMENTS
    1. Qualification of an Importer/ Distributor
    2. Responsibilities of an Importer/ Distributor
  9. INGREDIENTS
    1. Ingredient List
      1. Additives and Excipients
      2. Negative List of Substances for Traditional Medicine
    2. Approval of New Ingredients
  10. CONTAMINANTS CONTROL
    1. Limit on heavy metals:
    2. Limit for microbial contaminations
    3. Pesticide residues
  11. LABELLING REQUIREMENTS
  12. CLAIMS
  13. WAREHOUSING
  14. REFERENCES
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