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Information for Industry

Revised: 4 February 2014

Guideline on the Regulation of Therapeutic Products in New Zealand

Part 1: Overview of therapeutic product regulation.
(Under construction please refer to New Zealand Regulatory Guidelines for Medicines for current guidance (PDF 2.3 MB, 131 pages))

Part 2A: Over-the-counter medicines: Pre-market application and evaluation process (Microsoft Word document 2.14 MB, 30 pages)

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 (PDF 2.3 MB, 131 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.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance (PDF 2.3 MB, 131 pages))

Part 5: Labelling of medicines and related products ( Microsoft Word document 1.89 MB, 19 pages )

Part 6: Bioequivalence of medicines.
(Under construction please refer to the New Zealand Regulatory Guidelines for Medicines for current guidance (PDF 2.3 MB, 131 pages))

Part 7: Advertising of therapeutic products (Microsoft Word document 3.44 MB, 13 pages)

Part 8: Pharmacovigilance ( Microsoft Word document 251 KB, 6 pages )

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

Part 10: Requirements for information for prescribers and consumers (Microsoft Word document 1.74 MB, 16 pages)

Part 11: Good Clinical Research Practice and obtaining approval for clinical trials. (Microsoft Word document 1.80 MB, 24 pages)

 

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