Medsafe Logo


REGULATORY INFORMATION

Home  |  Consumers  |  Health Professionals  |  Regulatory  |  Other  |  Hot Topics  |  Search

Forms

  1. Section 29 Declaration/Notification Form (Microsoft Word 26KB)
  2. Reporting Adverse Reactions to Medicines, Vaccines and Devices and all Clinical Events for IMMP (Microsoft Word 42KB)
  3. Reporting Adverse Reactions to Fractionated Blood Products (Microsoft Word 45KB)
  4. Medical Device Incident Reporting Form (Microsoft Word 3,352KB)
  5. Clinical Trial Application Form (Microsoft Word 90KB)  - version effective from 1 July 2009
  6. Changed Medicine Notification Form A (Microsoft Word 184KB) - version effective from 1 July 2009
  7. Changed Medicine Notification Form B (Microsoft Word 152KB)- version effective from 1 July 2009
  8. CMI Declaration (Microsoft Word 21KB)
  9. Data Sheet Declaration (Microsoft Word 20KB)
  10. Data Sheet Self-assessment Checklist (Microsoft Word 47KB)
  11. Labelling Declaration (Microsoft Word 14KB)
  12. Medicine Labelling Self-Assessment Checklist (Microsoft Word 37KB)
  13. Contact Lens Solution Labelling Self-Assessment Checklist (Microsoft Word 22KB)
  14. Related Product Labelling Self-Assessment Checklist (Microsoft Word 24KB)
  15. New Medicine Application (Microsoft Word 183KB) - version effective from 1 July 2009
  16. New Medicine Application for use with the abbreviated evaluation process (Microsoft Word 163KB) - version effective from 1 July 2009
  17. New Related Product Application (Microsoft Word 76KB) - version effective from 1 July 2009
  18. Changed Related Product Notification (Microsoft Word 120KB) - version effective from 1 July 2009
  19. Checklist for New Prescription Medicines Applications (CTD) (Microsoft Word 965KB) - version effective from 12 Mar 2009