REGULATORY INFORMATION

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Forms

1. Certificate of Pharmaceutical Product (Microsoft Word 44KB)
2. Changed Medicine Notification Form A (effective from April 2013) (Microsoft Word 137KB)
3. Changed Medicine Notification Form B (effective from October 2012) (Microsoft Word 114KB)
4. Changed Related Product Notification (effective from October 2012) (Microsoft Word 94KB)
5. Application for approval of a clinical trial under Section 30 of the Medicines Act 1981 (Microsoft Word document 205KB) or Login to Online Forms
6. Clinical Trial Site Self-Certification Form (Microsoft Word document 91KB)
7. Clinical Trial Six Monthly Report (Microsoft Word document 67KB) or Login to Online Forms
8. Template for preparing CMI for New Zealand consumers (Microsoft Word document 75KB)
9. Declaration to accompany a CMI submitted for publication (Microsoft Word document 46KB)
10. Checklist for a New Zealand format data sheet (Microsoft Word document 305KB)
11. Declaration to accompany a data sheet submitted for approval (Microsoft Word document 40KB)
12. Declaration to accompany a data sheet submitted for publication (effective from October 2012) (Microsoft Word document 42KB)
13. Drug Master File / Plasma Master File / Certificate of Suitability (effective from September 2012) (Microsoft Word 45KB)
14. GMP Compliance Form (Microsoft Word 40KB)
15. Medical Device Incident Reporting Form (Microsoft Word 3,352KB)
16. Guide to Completing a New Medicine Application - OTC Medicine (effective from April 2013) (Microsoft Word document 156KB)
17. New Medicine Application - OTC Medicine Form (effective from April 2013) (Microsoft Word non-macro enabled form 207KB)
18. New Medicine Application - OTC Medicine  Declarations and Commitments (effective from April 2013) (Microsoft Word 80KB)
19. Guide to Completing a New Medicine Application - Prescription Medicine (effective from April 2013) (Microsoft Word document 149KB)
20. New Medicine Application - Prescription Medicine Form (effective from April 2013) (Microsoft Word non-macro enabled form 205KB)
21. New Medicine Application - Prescription Medicine  Declarations and Commitments (effective from April 2013) (Microsoft Word 80KB)
22. Guide to Completing a New Related Product Application (effective from April 2013) (Microsoft Word document 130KB)
23. New Related Product Application Form (effective from April 2013) (Microsoft Word non-macro enabled form 184KB)
24. New Related Product Declarations and Commitments (effective from April 2013) (Microsoft Word 72KB)
25. Proprietary Ingredient Form (Adobe PDF document 30KB)
26. Section 29 Declaration/Notification Form (Microsoft Word 26KB)