Published: 31 July 2019
Information for Industry
Schedule of Fees Payable under the Medicines Act 1981 - Effective from 1 July 2019
NOTE- Medsafe will issue a tax invoice which will be sent to the applicant with the acknowledgement letter. Payments are to be made on an invoice basis only - do not send payment with the application/notification
- All fees listed are GST Inclusive
- More detailed descriptions of the type of application or change to which a fee applies can be found on the relevant application form.
Printable version of fees & charges at Effective from 1 July 2019 (pdf 164kb, 10 pages)
New Medicine Application (NMA) Fees
New Medicine Application (Abbreviated Evaluation Process) Fees
New Related Product Application (NRPA) Fees
New Medicine Application (Provisional Consent) Fees
Changed Medicine Notifications (CMN) Fees
Change Related Product Notification (CRPN) Fees
Clinical Trial Application Fees
New Medicine Application (NMA) Fees
| Type of application | New fee ($) |
|---|---|
| New higher-risk medicine containing one or more new active substances | 102,210 |
| Any other new higher-risk medicine | 43,875 |
| New intermediate-risk medicine – prescription medicine | 43,875 |
| New intermediate-risk medicine – non-prescription medicine | 10,220 |
| New lower-risk medicine | 10,220 |
| Additional dose form – higher-risk medicine – Grade 1 or 2 | 43,875 |
| Additional dose form – intermediate-risk prescription medicine – Grade 1 or 2 | 43,875 |
| Additional dose form – intermediate-risk non-prescription medicine – Grade 1 or 2 | 10,220 |
| Additional dose form – lower-risk medicine – Grade 1 or 2 | 10,220 |
| New combination pack containing two or more currently approved products | 3,680 |
| Additional names, strengths, flavours and classifications notified at the same time as the parent application | 0 |
| The following fees apply when the additions are subsequent to the parent application | |
| Additional name − Grade 1 | 830 |
| Additional name − Grade 2 | 1,660 |
| Additional classification (with/without new name) | 830 |
| Additional strength − Grade 1 | 2,490 |
| Additional strength − Grade 2 | 3,320 |
| Additional strength − Grade 3 | 6,640 |
| Additional strength − Grade 4 | 20,700 |
| Additional strength − Grade 5 | 31,050 |
| Additional flavour or type of sweetening | 1,660 |
New Medicine Application (Abbreviated Evaluation Process) Fees
| Type of application | New fee ($) |
|---|---|
| New higher-risk medicine containing one or more new active substances | 51,100 |
| Any other new higher-risk medicine | 21,940 |
| New intermediate-risk medicine – prescription medicine | 21,940 |
| Additional names, strengthens, flavours and classifications must be notified at the same time as the parent application |
New Related Product Application (NRPA) Fees
| Type of application | New fee ($) |
|---|---|
| New related product | 5,500 |
| Additional names, strengths, flavours and classifications notified at the same time as the parent application | 0 |
| The following fees apply when the additions are subsequent to the parent application | |
| Additional name − Grade 1 | 830 |
| Additional name − Grade 2 | 1,660 |
| Additional strength | 1,660 |
| Additional flavour or type of sweetening | 1,660 |
New Medicine Application (Provisional Consent) Fees
| Type of application | New fee ($) |
|---|---|
| Application for provisional consent to distribute a new medicine | 8,437 |
| Application for renewal of provisional consent | 500 |
Changed Medicine Notifications (CMN) Fees
Non-Biological Medicine (CMN Form A)
Notifying a material change (including self-assessable changes) to an approved Type I product (lower- risk medicine) or a Type II product (intermediate- or higher-risk medicine other than a biological or biotechnological product − but including antibiotics and like substances derived from micro-organisms). Note: In no case will the CMN/Change Related Product Notification (CRPN) fee for a single product exceed the fee for a new medicine application for a product of the same type
| Type of application | New fee ($) |
|---|---|
| Product name | |
| Product name, for each new name | 830 |
| Formulation | |
| Formulation − Grade 1, Type 1 | 1,660 |
| Formulation − Grade 1, Type 2 | 2,490 |
| Formulation − Grade 2, Type 1 | 1,660 |
| Formulation − Grade 3, Type 1 | 2,075 |
| Formulation − Grade 4, Type 1 | 2,490 |
| Formulation − Grade 4, Type 2 | 3,200 |
| Active ingredient | |
| Active ingredient manufacturing site | 830 |
| Active ingredient manufacturing process − Grade 1, Type 1 | 830 |
| Active ingredient manufacturing process - Grade 1, Type 2 | 830 |
| Active ingredient manufacturing process − Grade 2, Type 1 | 3,200 |
| Active ingredient manufacturing process − Grade 2, Type 2 | 3,200 |
| Active ingredient manufacturing process − Grade 3, Type 1 | 830 |
| Active ingredient manufacturing process − Grade 3, Type 2 | 830 |
| Active ingredient specifications/test methods − Grade 1 | 415 |
| Active ingredient specifications/test methods − Grade 2 | 830 |
| Active ingredient specifications/test methods − Grade 3 | 830 |
| Active ingredient specifications/test methods − Grade 4, Type 1 | 830 |
| Active ingredient specifications/test methods − Grade 4, Type 2 | 1,660 |
| Excipient | |
| Excipient specifications/test methods − Grade 1 | 415 |
| Excipient specifications/test methods − Grade 2 | 830 |
| Excipient specifications/test methods − Grade 3 | 830 |
| Finished product | |
| Finished product packing site − Grade 1 | 830 |
| Finished product packing site − Grade 2 | 1,660 |
| Finished product manufacturing process − Grade 1, Type 1 | 1,660 |
| Finished product manufacturing process − Grade 1, Type 2 | 2,490 |
| Finished product manufacturing process − Grade 2, Type 1 | 2,490 |
| Finished product manufacturing process − Grade 2, Type 2 | 3,200 |
| Finished product specifications/test methods − Grade 1 | 415 |
| Finished product specifications/test methods − Grade 2 | 415 |
| Finished product specifications/test methods − Grade 3 | 415 |
| Finished product specifications/test methods − Grade 4 | 830 |
| Finished product specifications/test methods − Grade 5, Type 1 | 830 |
| Finished product specifications/test methods − Grade 5, Type 2 | 1,660 |
| Product stability and packaging | |
| Shelf life/storage conditions − Grade 1 | 415 |
| Shelf life/storage conditions − Grade 2 | 1,660 |
| Container/closure/packaging − Grade 1 | 415 |
| Container/closure/packaging − Grade 2 | 830 |
| Container/closure/packaging − Grade 3 | 1,660 |
| Container/closure/packaging − Grade 4 | 2,490 |
| Container/closure/packaging − Grade 5 | 3,200 |
| Indications and dosage | |
| Indications/dosage − Grade 1 | 3,200 |
| Indications/dosage − Grade 2 | 3,200 |
| Indications/dosage − Grade 3 | 3,200 |
| Indications/dosage − Grade 4 | 830 |
| Indications/dosage − Grade 5 | 830 |
| Contraindications, Warnings and Precautions | 3,200 |
| Data sheet | |
| Data sheet − miscellaneous changes | 415 |
| Data sheet − format change (an administration fee applies if this is the sole change) | 0 |
| Labelling | |
| Labelling − Grade 1 | 415 |
| Labelling − Grade 2 | 830 |
| Labelling − Grade 3 | 830 |
| Other | |
| Sponsor | 415 |
| Change in ownership | 830 |
| Self-assessable change(s) | 415 |
| Administration Fee | 415 |
Biological or Biotechnological Medicine (CMN Form B)
Notifying a material change (including self-assessable
changes) to an approved Type III (biological or biotechnological) product
(ie, a vaccine, recombinant product, monoclonal antibody or variant
thereof, or a medicinal product derived from blood or plasma).
Note: In no case will the CMN/CRPN fee for a single
product exceed the fee for a new medicine application for a product
of the same type.
| Type of application | New fee ($) |
|---|---|
| Product name | |
| Product name, for each new name | 830 |
| Formulation/excipients | |
| Formulation − Grade 1 | 3,200 |
| Formulation − Grade 2 | 830 |
| Bulk active | |
| Active ingredient manufacturing site | 3,200 |
| Active ingredient method of manufacture – Grade 1 | 3,200 |
| Active ingredient method of manufacture – Grade 2 | 830 |
| Active ingredient method of manufacture – grade 3 | 415 |
| Finished product | |
| Finished product manufacturing site | 3,200 |
| Finished product secondary packing site | 830 |
| Finished product testing site | 1.660 |
| Finished product manufacturing process − Grade 1 | 3,200 |
| Finished product manufacturing process – Grade 2 | 3,200 |
| Finished product manufacturing process – Grade 3 | 830 |
| Finished product manufacturing process – Grade 4 | 415 |
| Excipient | |
| Excipient specifications/test methods – Grade 1 | 415 |
| Excipient specifications/test methods – Grade 2 | 830 |
| Excipient specifications/test methods – Grade 3 | 830 |
| Test methods and specifications | |
| Test methods and specifications − Grade 1 | 3,200 |
| Test methods and specifications − Grade 2 | 3,200 |
| Test methods and specifications − Grade 3 | 3,200 |
| Test methods and specifications − Grade 4 | 1,660 |
| Test methods and specifications − Grade 5 | 1,660 |
| Test methods and specifications − Grade 6 | 415 |
| Product stability and packaging | |
| Shelf life/storage conditions − active ingredient and intermediate bulks | 1,660 |
| Shelf life/storage conditions − finished product | 1,660 |
| Shelf life/storage conditions – Reference standard – Grade 1 | 1660 |
| Shelf life/storage conditions – Reference standard – Grade 2 | 415 |
| Container/closure/packaging − Grade 1 | 1,660 |
| Container/closure/packaging − Grade 2 | 3,200 |
| Container/closure/packaging − Grade 3 | 830 |
| Container/closure/packaging – Grade 4 | 415 |
| Indications and dosage | |
| Indications/dosage − Grade 1 | 3,200 |
| Indications/dosage − Grade 2 | 3,200 |
| Indications/dosage − Grade 3 | 3,200 |
| Indications/dosage − Grade 4 | 830 |
| Indications/dosage − Grade 5 | 830 |
| Contraindications, Warnings and Precautions | 3,200 |
| Labelling | |
| Labelling − Grade 1 | 415 |
| Labelling − Grade 2 | 830 |
| Labelling − Grade 3 | 830 |
| Data Sheet | |
| Data sheet − miscellaneous changes | 415 |
| Data sheet − format change (an administration fee applies if this is the sole change) | 0 |
| Other | |
| Sponsor | 415 |
| Change in ownership | 830 |
| Self-assessable change(s) | 415 |
| Administration fee | 415 |
Change Related Product Notification (CRPN) Fees
Notifying a material change (including self-assessable changes) to an approved related product. Note: In no case will the CMN/CRPN fee for a single product exceed the fee for a new medicine application for a product of the same type.
| Type of application | New fee ($) |
|---|---|
| Productname | |
| Product name | 830 |
| Formulation | |
| Formulation − Grade 1 | 1,245 |
| Formulation − Grade 2 | 1,245 |
| Formulation − Grade 3 | 2,490 |
| Active ingredient | |
| Active ingredient specifications/test methods − Grade 1 | 415 |
| Active ingredient specifications/test methods − Grade 2 | 830 |
| Finished product | |
| Finished product packing site | 830 |
| Finished product manufacturing site − Grade 1 | 830 |
| Finished product manufacturing site − Grade 2 | 2,490 |
| Finished product manufacturing process − Grade 1 | 1,660 |
| Finished product manufacturing process − Grade 2 | 2,490 |
| Finished product specifications/test methods | 830 |
| Product stability and packaging | |
| Shelf life/storage conditions − Grade 1 | 415 |
| Shelf life/storage conditions − Grade 2 | 1,660 |
| Container/closure/packaging − Grade 1 | 415 |
| Container/closure/packaging − Grade 2 | 830 |
| Container/closure/packaging − Grade 3 | 1,660 |
| Indications and dosage | |
| Indications/dosage − Grade 1 | 3,200 |
| Indications/dosage − Grade 2 | 1,245 |
| Indications/dosage − Grade 3 | 1,245 |
| Indications/dosage − Grade 4 | 830 |
| Labelling | |
| Labelling − Grade 1 | 415 |
| Labelling − Grade 2 | 830 |
| Other | |
| Sponsor | 415 |
| Self-assessable change(s) | 415 |
| Administration fee | 415 |
Clinical Trial Application Fees
| Type of application | New fee ($) |
|---|---|
| Application for consent to conduct a clinical trial | 7,500 |
| Additional clinical trial for the same medicine, submitted at the same time | 3,750 |
| Application for consent to conduct a clinical trial – abbreviated approval process | 415 |
Licences and Other Fees
| Type of application | New fee ($) |
|---|---|
| Appeal to the Medicines Review Committee | 9,000 |
| Issue of a Certificate of Pharmaceutical Product | 250 |
| Licence to Manufacture Medicines | 13,750 |
| Licence to Pack Medicines | 845 |
| GMP Certificates | 178.25 |
| Medical Devices – Regulatory Statements to Foreign Governments (per statement) | 178.25 |
| Dietary Supplements - Regulatory Statements to Foreign Governments (per statement) | 178.25 |
| Dietary Supplements – additional copy of original certificate issued at the same time (per statement) | 25.00 |
| New Zealand Based − Auditing of Non-Licensed Manufacturers − per hour, plus $50 administration fee, plus disbursements | 178.25 per hour |
| Overseas Auditing of Manufacturers $250 per hour (plus GST if applicable) for technical time $200 per hour for travel time (up to a maximum of 8 hours per day) plus $50 administration fee, plus disbursements |
Information on the following Licences:
- Licence to Sell by Wholesale
- Licence to Sell Medicines by Retail
- Licence to Hawk Medicines
- Licence to Operate a Pharmacy
- Licence to deal in Controlled Drugs
- Licence to possess Controlled Drugs
- Licence to import Controlled Drugs
- Licence to export Controlled Drugs
can be obtained by contacting Medicines Control: - https://www.health.govt.nz/about-ministry/contact-us/groups/medicines-control-contacts
