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

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

Auditing of Manufacturers - $135 per hour, plus $50 Admin fee, plus disbursements