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Why you should buy this report

This comprehensive report provides precise information on the Regulatory landscape of Peru, so as to enable a Regulatory go-to-market strategy and ensure compliance. 

 

Summary
  • Information on the approval or registration process of traditional medicine;
  • Covers details on the documentation and fees required for submission, submission modes (online/in person), qualification of the importer etc;
  • Explains the process of registration in a simple way through flowcharts;
  • Includes the process of registering ingredients that are not listed in Peru;
  • Provides a list of prohibited/restricted ingredients to check formulation compliance;
  • Lists out the limits of contaminants; and
  • Lays down all the regulations governing traditional medicine in Peru.
Table of Contents
  1. LIST OF ABBREVIATIONS
  2. INTRODUCTION
  3. DEFINITION
  4. IMPORT AND PRODUCT REGISTRATION
    1. Registration of Branch Office in Peru

      1. Documents Required
      2. Process
      3. Fee and Timeline
    2. Product Registration
      1. Documents Required
      2. Submission Mode
      3. Registration Process
      4. Fee and Timeline
    3. Import Permit
  5. Validity and Renewal
    1. Documents Required
    2. Renewal Process, Fee and Timeline
  6. VARIATIONS
    1. Minor Changes
    2. Major Changes
    3. Documents for Variation Application
    4. Process of Variation Application
    5. Fee and Timeline
  7. LOCAL AGENT REQUIREMENTS
    1. Qualifications of an Importer/ Distributor
    2. Responsibilities of an Importer/ Distributor
    3. Qualification and Responsibilities of a Sanitary Responsible person
  8. INGREDIENTS
    1. Permitted and Prohibited Ingredients
    2. New Ingredient Registration 7
      1. Documents Required
      2. Registration Process
      3. Fee and Timeline
  9. CONTAMINANTS
  10. LABELLING
  11. ADVERTISING
  12. CLAIMS
  13. WAREHOUSING
    1. Documents Required for Warehouse Licensing
    2. Warehouse Licensing Process
    3. Fee and Timeline
  14. REFERENCES
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