Effective from 1 October 2010
NOTE
Printable version of fees & charges at 1 October 2010 (pdf,96kb)
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
| Type of application | Fee |
|---|---|
| New higher-risk medicine containing one or more new active substances | 88,875 |
| Any other new higher-risk medicine | 43,875 |
| New intermediate risk medicine - prescription medicine | 43,875 |
| New intermediate risk medicine - non-prescription medicine | 7,650 |
| New lower-risk medicine | 7,650 |
| 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 | 7,650 |
| Additional dose form - lower-risk medicine - Grade 1 or 2 | 7,650 |
| New combination pack containing 2 or more currently approved products | 3,200 |
| Additional names, strengths, flavours and classifications submitted at the same time as the parent application | 0 |
| Additional names, strengths, flavours and classifications submitted subsequent to the parent application | |
| Additional name - Grade 1 | 720 |
| Additional name - Grade 2 | 1,440 |
| Additional classification (with/without new name) | 720 |
| Additional strength - Grade 1 | 2,160 |
| Additional strength - Grade 2 | 2,880 |
| Additional strength - Grade 3 | 5,760 |
| Additional strength - Grade 4 | 18,000 |
| Additional strength - Grade 5 | 27,000 |
| Additional flavour or type of sweetening | 1,440 |
| Type of application | Fee |
|---|---|
| New higher-risk medicine containing one or more new active substances | 33,750 |
| Any other new higher-risk medicine | 33,750 |
| New intermediate risk medicine - prescription medicine | 16,875 |
| Additional dose forms, names, strengths, flavours and classifications NOTE: these must be submitted at the same time as the parent application |
0 |
| Type of application | Fee |
|---|---|
| New related product | 5,500 |
| Additional names, strengths, flavours and classifications submitted at the same time as the parent application | 0 |
| Additional names, strengths, flavours and classifications submitted subsequent to the parent application: | |
| Additional name - Grade 1 | 720 |
| Additional name - Grade 2 | 1,440 |
| Additional strength | 1,440 |
| Additional flavour or type of sweetening | 1,440 |
| Type of application | Fee |
|---|---|
| Application for provisional consent to distribute a new medicine | 8,437 |
| Application for renewal of provisional consent | 500 |
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/CRPN fee for a single product exceed the fee for a new medicine application
for a product of the same type.
| Type of application | Fee |
|---|---|
| Product name | |
| Product name, for each new name | 720 |
| Formulation | |
| Formulation - Grade 1, Type 1 | 1,440 |
| Formulation - Grade 1, Type 2 | 2,160 |
| Formulation - Grade 2, Type 1 | 1,440 |
| Formulation - Grade 3, Type 1 | 1,800 |
| Formulation - Grade 4, Type 1 | 2,160 |
| Formulation - Grade 4, Type 2 | 2,880 |
| Active ingredient | |
| Active ingredient manufacturing site | 720 |
| Active ingredient manufacturing process - Grade 1, Type 1 | 720 |
| Active ingredient manufacturing process - Grade 1, Type 2 | 720 |
| Active ingredient manufacturing process - Grade 2, Type 1 | 2,880 |
| Active ingredient manufacturing process - Grade 2, Type 2 | 2,880 |
| Active ingredient manufacturing process - Grade 3, Type 1 | 720 |
| Active ingredient manufacturing process - Grade 3, Type 2 | 720 |
| Active ingredient specifications/test methods - Grade 1 | 360 |
| Active ingredient specifications/test methods - Grade 2 | 720 |
| Active ingredient specifications/test methods - Grade 3 | 720 |
| Active ingredient specifications/test methods - Grade 4, Type 1 | 720 |
| Active ingredient specifications/test methods - Grade 4, Type 2 | 1,440 |
| Excipient | |
| Excipient specifications/test methods - Grade 1 | 360 |
| Excipient specifications/test methods - Grade 2 | 720 |
| Excipient specifications/test methods - Grade 3 | 720 |
| Finished product | |
| Finished product packing site - Grade 1 | 720 |
| Finished product packing site - Grade 2 | 1,440 |
| Finished product manufacturing process - Grade 1, Type 1 | 1,440 |
| Finished product manufacturing process - Grade 1, Type 2 | 2,160 |
| Finished product manufacturing process - Grade 2, Type 1 | 2,160 |
| Finished product manufacturing process - Grade 2, Type 2 | 2,880 |
| Finished product specifications/test methods - Grade 1 | 360 |
| Finished product specifications/test methods - Grade 2 | 360 |
| Finished product specifications/test methods - Grade 3 | 360 |
| Finished product specifications/test methods - Grade 4 | 720 |
| Finished product specifications/test methods - Grade 5, Type 1 | 720 |
| Finished product specifications/test methods - Grade 5, Type 2 | 1,440 |
| Product stability and packaging | |
| Shelf life/storage conditions - Grade 1 | 360 |
| Shelf life/storage conditions - Grade 2 | 1,440 |
| Container/closure/packaging - Grade 1 | 360 |
| Container/closure/packaging - Grade 2 | 720 |
| Container/closure/packaging - Grade 3 | 1,440 |
| Container/closure/packaging - Grade 4 | 2,160 |
| Container/closure/packaging - Grade 5 | 2,880 |
| Indications and dosage | |
| Indications/dosage - Grade 1 | 2,880 |
| Indications/dosage - Grade 2 | 2,880 |
| Indications/dosage - Grade 3 | 2,880 |
| Indications/dosage - Grade 4 | 720 |
| Indications/dosage - Grade 5 | 720 |
| Contraindications, Warnings and Precautions | 2,880 |
| Data sheet | |
| Data sheet - miscellaneous changes | 360 |
| Labelling | |
| Labelling - Grade 1 | 360 |
| Labelling - Grade 2 | 720 |
| Labelling - Grade 3 | 720 |
| Other | |
| Sponsor | 360 |
| Self-assessable change(s) | 360 |
| Administration Fee | 360 |
Notifying a material change (including self-assessable changes) to an approved Type III (biological or
biotechnological) product (i.e., 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 | Fee |
|---|---|
| Product name | |
| Product name, for each new name | 720 |
| Formulation/Excipients | |
| Formulation - Grade 1 | 2,880 |
| Formulation - Grade 2 | 720 |
| Bulk Active | |
| Bulk Active manufacturing site | 2,880 |
| Bulk Active methods of manufacture | 2,880 |
| Change in site of lyophilisation | 1,440 |
| Revalidation of lyophilisation process | 1,440 |
| Active ingredient method of manufacture | 720 |
| Finished product manufacturing site | 2,880 |
| Finished product secondary packing site | 720 |
| Finished product manufacturing process - Grade 1 | 2,880 |
| Finished product manufacturing process - Grade 2 | 2,880 |
| Finished product manufacturing process | 720 |
| Test methods and specifications | |
| Test methods and specifications - Grade 1 | 2,880 |
| Test methods and specifications - Grade 2 | 2,880 |
| Test methods and specifications - Grade 3 | 2,880 |
| Test methods and specifications - Grade 4 | 1,440 |
| Test methods and specifications - Grade 5 | 1,440 |
| Test methods and specifications - Grade 6 | 360 |
| Product stability and packaging | |
| Shelf life/storage conditions - Bulk Actives and Intermediate Bulks | 1,440 |
| Shelf life/storage conditions - Finished Product | 1,440 |
| Container/closure/packaging - Grade 1 | 1,440 |
| Container/closure/packaging - Grade 2 | 2,880 |
| Container/closure/packaging - Grade 3 | 360 |
| Indications and dosage | |
| Indications/dosage - Grade 1 | 2,880 |
| Indications/dosage - Grade 2 | 2,880 |
| Indications/dosage - Grade 3 | 2,880 |
| Indications/dosage - Grade 4 | 720 |
| Indications/dosage - Grade 5 | 720 |
| Contraindications, Warnings and Precautions | 2,880 |
| Labelling | |
| Labelling - Grade 1 | 360 |
| Labelling - Grade 2 | 720 |
| Labelling - Grade 3 | 720 |
| Data Sheet | |
| Data sheet - miscellaneous changes | 360 |
| Other | |
| Sponsor | 360 |
| Self-assessable change(s) | 360 |
| Administration Fee | 360 |
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 | Fee | |
|---|---|---|
| Product name | ||
| Product name | 720 | |
| Formulation | ||
| Formulation - Grade 1 | 1,080 | |
| Formulation - Grade 2 | 1,080 | |
| Formulation - Grade 3 | 2,160 | |
| Active ingredient | ||
| Active ingredient specifications/test methods - Grade 1 | 360 | |
| Active ingredient specifications/test methods - Grade 2 | 720 | |
| Finished product | ||
| Finished product packing site | 720 | |
| Finished product manufacturing site - Grade 1 | 720 | |
| Finished product manufacturing site - Grade 2 | 2,160 | |
| Finished product manufacturing process - Grade 1 | 1,440 | |
| Finished product manufacturing process - Grade 2 | 2,160 | |
| Finished product specifications/test methods | 720 | |
| Product stability and packaging | ||
| Shelf life/storage conditions - Grade 1 | 360 | |
| Shelf life/storage conditions - Grade 2 | 1,440 | |
| Container/closure/packaging - Grade 1 | 360 | |
| Container/closure/packaging - Grade 2 | 720 | |
| Container/closure/packaging - Grade 3 | 1,440 | |
| Indications and dosage | ||
| Indications/dosage - Grade 1 | 2,880 | |
| Indications/dosage - Grade 2 | 1,080 | |
| Indications/dosage - Grade 3 | 1,080 | |
| Indications/dosage - Grade 4 | 720 | |
| Labelling | ||
| Labelling - Grade 1 | 360 | |
| Labelling - Grade 2 | 720 | |
| Other | ||
| Sponsor | 360 | |
| Self-assessable change(s) | 360 | |
| Administration Fee | 360 | |
| Type of application | Fee |
|---|---|
| Application for consent to conduct a clinical trial | 6,525 |
| Additional clinical trial for the same medicine, submitted at the same time | 3,263 |
| Application for consent to conduct a clinical trial – abbreviated approval process | 360 |
| Type of application | 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 | 135 |
| Medical Devices - Regulatory Statements to Foreign Governments (per statement) | 135 |
| Dietary Supplements - Regulatory Statements to Foreign Governments (first statement) | 135 |
| Dietary Supplements - additional copies issued at the same time (per statement) | 22.50 |
| Auditing of Non-Licensed Manufacturers - $138 per hour, plus $50 Admin fee, plus disbursements | |
Information on the following Licences:
can be obtained by contacting Medicines Control: - http://www.moh.govt.nz/moh.nsf/indexmh/medicinescontrol-contact
