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