Revised: 15 January 2026
Information for Industry
Forms and Templates
Administration and Maintenance of Product Files
- Product Status Change Request Form (effective from November 2019) (Word, 21 KB, 1 page )
- Request for Removal of Manufacturing, Testing or Packing Site from Therapeutic Product Database Report (effective from November 2020) (Word 41 KB, 1 page)
- Changing the Status of a Presentation or Pack Size form (June 2025) (Word 40 KB, 1 page)
Blood and Blood Components
- Changes to the Collection and Manufacturing Standards for New Zealand Blood Service (effective from February 2018 ) (Word, 41 KB,1 page)
Certificate of Pharmaceutical Product
- Application to accompany a request for a Certificate of Pharmaceutical Product (effective from October 2020) ( Word, 27KB, 1 page)
Clinical Trials
- Application form please login to Ethics Review Manager (ETHICS RM)
- Clinical Trial Site Notification Form (Word 17 KB, 2 pages)
- Investigator CV template (Word, 56 KB, 1 page)
Consumer Medicine Information
- Template for preparing CMI for New Zealand consumers (Word, 68 KB, 8 pages)
- Declaration to accompany a CMI submitted for publication (Word 45 KB, 1 page)
Data Sheets
- Declaration to accompany a data sheet (December 2023) (Word, 39 KB, 1 page)
- 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 ( Word, 50KB, 1 page)
- Application form for an Export Certificate for Dietary Supplements (Word, 31KB, 3 pages)
Export Certificates
- Application to accompany a request for a Certificate of Pharmaceutical Product (Word, 44 KB, 1 page)
- Application form for an Export Certificate for Dietary Supplements (Word, 21 KB, 2 pages)
Medical Devices
- Adverse Event Report (Consumers) (Word, 85 KB, 3 pages)
- Adverse Event Report (Healthcare Professionals) (Word, 79 KB, 3 pages)
- Adverse event report (industry) (Word, 113 KB, 3 pages)
- Quality incident report (Word, 74 KB, 3 pages)
Medicines - (Changed Medicine Notification Forms)
- Changed Medicine Notification Form A (use from 1 February 2024) (Word, 85 KB, 21 pages)
- Changed Medicine Notification Form B (use from 1 February 2024) (Word, 82 KB, 24 pages)
Medicines - (New Medicine Application Forms)
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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) (Word, 45 KB, 9 pages)
- New Medicine Application - OTC Medicine Declarations and Commitments (effective from February 2018) (Word, 81 KB, 5 pages)
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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) (Word, 58 KB, 12 pages )
- New Medicine Application - Prescription Medicine Declarations and Commitments (effective from November 2017) (Word, 84 KB, 7 pages)
Medicine Ingredients (Actives Substances, Plasma and Proprietary Ingredients - Forms)
- Drug Master File / Certificate of Suitability (New and Updated) Application Form (Word, 52 KB, 4 pages)
- Plasma Master File (New and Updated) Application Form (effective from January 2025) (Word 44 KB, 2 pages)
- Proprietary Ingredient Registration Application Form (Word 69KB, 1 page)
Related Products - (New and Changed)
- Changed Related Product Notification (effective from May 2023) (Word, 219 KB, 2 pages)
- 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) (Word, 38 KB, 20 pages)
- New Related Product Declarations and Commitments (effective from February 2018) (Word, 73 KB, 9 pages)
Unapproved Medicines (Section 29)
- Section 29 Declaration/Notification Form (Word, 26 KB, 4 pages)
Approval to Prescribe Psychedelics
- Application form for Approval to Prescribe Psychedelics for psychedelic-assisted therapy (PDF, 890KB, 6 pages) - For further guidance please see here
