Medsafe Guidelines - New Zealand

Guideline on the Regulation of Therapeutic Products in New Zealand

Part 1: Overview of therapeutic product regulation.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance.
Part 2A: Over-the-counter medicines: Pre-market application and evaluation process (Microsoft Word document 2550KB)

• Appendix 1: Application selection tools
• Appendix 2: OTC medicines changes tables

Part 2B: Obtaining approval for new and changed prescription medicines and related products.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)
Part 3: Regulatory requirements for medical devices.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)

Part 4: Manufacture of medicines.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)
Part 5: Labelling of medicines and related products (Microsoft Word document 3649KB)
Part 6: Bioequivalence of medicines.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)
Part 7: Advertising of therapeutic products (Microsoft Word document 3533KB)
Part 8: Pharmacovigilance (Microsoft Word document 249KB)
Part 9: Therapeutic product safety alerts, complaints and recalls.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance)
Part 10: Requirements for information for prescribers and consumers (Microsoft Word document 3534KB)
Part 11: Good Clinical Research Practice and obtaining approval for clinical trials. (Microsoft Word document 1853KB)

New Zealand Regulatory Guidelines for Medicines

• The categorization of electronic cigarettes
• Permitted Colourings for use in Medicines and Related Products
• Label Statements Database
• New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
• Proprietary Ingredients
• Guidelines for Standing Orders -Development and Operation
• Medsafe Policy on the acceptability of claims for pain relief
• Subdividing of Divided Tablets
• Medsafe’s Evaluation Policy for Priority and Abbreviated Assessments
• Medsafe’s Policy for Changing Registration Situation