Revised: 19 December 2019

Information for Industry

Current Guidelines on the Regulation of Therapeutic Products in New Zealand

Part 1: Overview of therapeutic product regulation. (PDF 3955 KB, 65 pages)

Part 2: Obtaining approval for new and changed medicines (PDF 1220KB, 65 Pages)

• Appendix 8: Data Requirements for New Medicine Applications (PDF 212 KB, 26 pages)

Part 3: Regulatory requirements for medical devices.
(Under construction please refer to the guidance for medical devices for current guidance)

Part 4: Manufacture of medicines (PDF 1058 KB, 13 pages)

Part 5: Labelling of medicines and related products (PDF 326 KB, 18 pages)

Part 6: Bioequivalence of medicines. (PDF 258  KB, 7 pages)

Part 7: Advertising of therapeutic products (PDF 134 KB, 15 pages)

Part 8: Pharmacovigilance Edition 2.1 (PDF 394 KB, 38 pages) (a summary of changes is included at the end of the document)

Part 9: Therapeutic product safety alerts, complaints and recalls.
(Under construction please refer to the uniform recall procedure PDF 469 KB, 49 pages)

Part 10: Requirements for information for prescribers and consumers (PDF 117 KB 13 pages)

• Data sheet template explanatory guide (PDF 241 KB, 25 pages)
• Data sheet template (Word 18 KB, 1 page)

Part 11: Regulatory approval and good clinical practice requirements (PDF 273 KB, 26 pages)

• Clinical Trial Site Notification Form (PDF 76 KB, 2 pages)