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Medicines

Effective from 1 October 2010

Schedule of Fees Payable under the Medicines Act 1981

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

Licences and Other Fees

New Medicine Application (NMA) 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

New Medicine Application (Abbreviated Evaluation Process) Fees

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

New Related Product Application (NRPA) Fees

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

New Medicine Application (Provisional Consent) Fees

Type of application 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/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
Biological or biotechnological medicine (CMN B Form)

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

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 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

Clinical Trial Application Fees

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

Licences and Other Fees

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

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