Information for Industry

Published: 25 May 2017

Schedule of Fees Payable under the Medicines Act 1981 - Effective from 1 JULY 2018

NOTE

Printable version of fees & charges at Effective from 1 July 2018 (pdf 164kb, 10 pages)

Staggered payment option of New Medicines Application (NMA) Fees - effective 1 July 2018 to 31 December 2018 only

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

Staggered payment option of New Medicines Application (NMA) Fees - effective 1 July 2018 to 31 December 2018 only

The new fee effective from 1 July 2018 is applicable. Applicants can opt to pay the total fee at once or in two parts. Please make your selection clear on the relevant application form. For the two part option, the initial fee can be paid when the application is submitted, with the balance to be invoiced by Medsafe in January 2019. This option is only available until 31 December 2018.

Type of application Initial fee ($) Balance due
Jan-19 ($)
Total Applicable Fee ($)
New higher-risk medicine containing one or more new active substances 88,875 13,335 102,210
New intermediate-risk medicine - non-prescription medicine 7,650 2,570 10,220
New lower-risk medicine 7,650 2,570 10,220
Additional dose form - intermediate-risk non-prescription medicine - Grade 1 or 2 7,650 2,570 10,220
Additional dose form - lower-risk medicine - Grade 1 or 2 7,650 2,570 10,220
Abbreviated evaluation process - New higher-risk medicine containing one or more new active substances 33,750 17,350 51,100
Abbreviated evaluation process - New intermediate-risk medicine - prescription medicine 16,875 5,065 21,940

 

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 B Form)

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
Manufacturing  
Bulk active manufacturing site 3,200
Bulk active methods of manufacture 3,200
Change in site of lyophilisation 1,660
Revalidation of lyophilisation process 1,660
Active ingredient method of manufacture 830
Finished product manufacturing site 3,200
Finished product secondary packing site 830
Finished product manufacturing process − Grade 1 3,200
Finished product manufacturing process − Grade 2 3,200
Finished product manufacturing process − 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 − bulk actives and intermediate bulks 1,660
Shelf life/storage conditions − finished product 1,660
Container/closure/packaging − Grade 1 1,660
Container/closure/packaging − Grade 2 3,200
Container/closure/packaging − Grade 3 415
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 ($)
Product name  
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 (first statement) 178.25
Dietary Supplements - additional copies 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:

can be obtained by contacting Medicines Control: - http://www.health.govt.nz/about-ministry/contact-us/groups/medicines-control-contacts