Guidelines & Codes
Guideline on the Regulation of Therapeutic Products in New Zealand
Schedule A - Forms and Templates
Part 1: Overview of therapeutic product regulation.
Part 2: Obtaining approval for new and changed medicines and related products.
Part 3: Regulatory requirements for medical devices.
Part 4: Manufacture of medicines.
Part 5: Labelling of medicines and related products.
Part 6: Bioequivalence of medicines.
Part 7: Advertising of therapeutic products.
Part 8: Pharmacovigilance.
Part 9: Therapeutic product safety alerts, complaints and recalls.
Part 10: Requirements for information for prescribers and consumers.
10.1 Checklist for a New Zealand format data sheet (Microsoft Word document 305KB)
10.2 Declaration to accompany a data sheet submitted for approval (Microsoft Word document 40KB)
10.3 Declaration to accompany a data sheet submitted for publication (Microsoft Word document 42KB)
10.4 Template for preparaing CMI for New Zealand consumers (Microsoft Word document 75KB)
10.5 Declaration to accompany a CMI submitted for publication (Microsoft Word document 46KB)
Part 11: Guideline on Good Clinical Research Practice and obtaining approval for clinical trials.
11.1 Application for approval of a clinical trial under Section 30 of the Medicines Act 1981 (Microsoft Word document 205KB)
11.2 Clinical Trial Site Self-Certification Form (Microsoft Word document 91KB)
11.3 Clinical Trial Six Monthly Report (Microsoft Word document 67KB)