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REGULATORY INFORMATION

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Forms

  1. Reporting Adverse Reactions to Medicines, Vaccines and Devices and all Clinical Events for IMMP (Microsoft Word 42KB)
  2. Reporting Adverse Reactions to Fractionated Blood Products (Microsoft Word 45KB)
  3. Changed Medicine Notification Form A (Microsoft Word 134KB)
  4. Changed Medicine Notification Form B (Microsoft Word 113KB)
  5. Changed Related Product Notification (Microsoft Word 120KB)
  6. Application for approval of a clinical trial under Section 30 of the Medicines Act 1981 (Microsoft Word document 205KB)
  7. Clinical Trial Site Self-Certification Form (Microsoft Word document 91KB)
  8. Clinical Trial Six Monthly Report (Microsoft Word document 67KB)
  9. Template for preparing CMI for New Zealand consumers (Microsoft Word document 75KB)
  10. Declaration to accompany a CMI submitted for publication (Microsoft Word document 46KB)
  11. Checklist for a New Zealand format data sheet (Microsoft Word document 305KB)
  12. Declaration to accompany a data sheet submitted for approval (Microsoft Word document 40KB)
  13. Declaration to accompany a data sheet submitted for publication (Microsoft Word document 42KB)
  14. GMP Compliance Form (Microsoft Word 40KB)
  15. Medical Device Incident Reporting Form (Microsoft Word 3,352KB)
  16. New Medicine/Related Product Application Form (Microsoft Word macro enabled form 306KB)
  17. Guide to Completing New Medicine/Related Product Application (Microsoft Word 166KB)
  18. New Medicine/Related Product Declarations and Commitments (Microsoft Word 93KB)
  19. Proprietary Ingredient Form (Adobe PDF document 30KB)
  20. Section 29 Declaration/Notification Form (Microsoft Word 26KB)