Revised: 15 April 2024
Information for Industry
Forms and Templates
Administration and Maintenance of Product Files
- Product Status Change Request Form (effective from November 2019) (Microsoft Word 21KB)
- Request for Removal of Manufacturing, Testing or Packing Site from Therapeutic Product Database Report (effective from November 2020) (Microsoft Word 41KB, 1 page)
Blood and Blood Components
- Changes to the Collection and Manufacturing Standards for New Zealand Blood Service (effective from February 2018 ) (Microsoft Word document 41KB)
Certificate of Pharmaceutical Product
- Application to accompany a request for a Certificate of Pharmaceutical Product (effective from October 2020) (Microsoft Word Document 27KB)
Clinical Trials
- Application form please login to Ethics Review Manager (ETHICS RM)
- Clinical Trial Site Notification Form (Word 17 KB, 2 pages)
Consumer Medicine Information
- Template for preparing CMI for New Zealand consumers (Microsoft Word document 75KB)
- Declaration to accompany a CMI submitted for publication (Microsoft Word document 45KB)
Data Sheets
- Declaration to accompany a data sheet (December 2023) (Microsoft Word document 39KB)
- Data sheet template explanatory guide (v1.2, PDF 448 KB, 26 pages)
- Data sheet template (v1.3, Word 35KB, 2 pages)
Dietary Supplements
- Sponsor declaration for a dietary supplement with a maximum daily dose of more than 300 mcg of folic acid (Microsoft Word document 50KB, 1 page)
- Application form for an Export Certificate for Dietary Supplements (Microsoft Word documents 31KB, 3 pages)
Export Certificates
- Application to accompany a request for a Certificate of Pharmaceutical Product (Microsoft Word document 44KB)
- Application form for an Export Certificate for Dietary Supplements (Microsoft Word documents 21KB, 2 pages)
Medical Devices
- Adverse Event Report (Consumers) (Microsoft Word document 85 KB, 3 pages)
- Adverse Event Report (Healthcare Professionals) (Microsoft Word document 79 KB, 3 pages)
- Adverse event report (industry) (Microsoft Word document 113 KB, 3 pages)
- Quality incident report (Microsoft Word document 74 KB, 3 pages)
Medicines - (Changed Medicine Notification Forms)
- Changed Medicine Notification Form A (use from 1 February 2024) (Microsoft Word, 21 pages 85KB)
- Changed Medicine Notification Form B (use from 1 February 2024) (Microsoft Word, 24 pages 82KB)
Medicines - (New Medicine Application Forms)
-
Lower-Risk Medicines
- Guide to Completing a New Medicine Application - Lower-Risk Medicines (effective from January 2023) (PDF 263 KB, 11 pages)
- New Medicine Application - Lower-Risk Medicines Form (effective from January 2023) (Microsoft Word 45 KB)
- New Medicine Application - OTC Medicine Declarations and Commitments (effective from February 2018) (Microsoft Word 81 KB)
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Intermediate-Risk and Higher-Risk Medicines
- Guide to Completing a New Medicine Application - Intermediate-Risk and Higher-Risk Medicines (effective from January 2023) (PDF 201 KB, 9 pages)
- New Medicine Application - Intermediate-Risk and Higher-Risk Medicines Form (effective from January 2023) (Microsoft Word 58 KB)
- New Medicine Application - Prescription Medicine Declarations and Commitments (effective from November 2017) (Microsoft Word 84 KB)
Medicine Ingredients (Actives Substances, Plasma and Proprietary Ingredients - Forms)
- Drug Master File / Certificate of Suitability (New and Updated) Application Form (Microsoft Word 52KB)
- Plasma Master File (New and Updated) Application Form (effective from October 2020) (Microsoft Word 57KB)
- Proprietary Ingredient Registration Application Form (Microsoft Word 69KB, 1 page)
Related Products - (New and Changed)
- Changed Related Product Notification (effective from Mayy 2023) (Microsoft Word 219 KB)
- Guide to Completing a New Related Product Application (effective from January 2023) (PDF 177 KB, 6 pages)
- New Related Product Application Form (effective from July 2022) (Microsoft Word 38 KB)
- New Related Product Declarations and Commitments (effective from February 2018) (Microsoft Word 73 KB)
Unapproved Medicines (Section 29)
- Section 29 Declaration/Notification Form (Microsoft Word 26 KB)
