Revised: 24 April 2022
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 2 MB, 66 Pages)
- Appendix 8: Data Requirements for New Medicine Applications (PDF 423 KB, 29 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 647 KB, 14 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 2.2 (PDF 424 KB, 35 pages)
Summary of Changes made to Part 8: Pharmacovigilance
Edition 2.2 (PDF 108 KB, 3 pages)
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 268 KB 13 pages)
Summary of Changes made to Part
10:
Requirements for information for prescribers and consumers (PDF
90 KB, 3 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)