Fees payable under the Medicines Act (effective from 1 October 2010)
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1 s payable under the Medicines Act 1981 (effective from 1 October 2010) NOTE 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 (available at New Medicines Application (NMA) s 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, strengthens, 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 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 Medicines Application (Abbreviated Evaluation Process) s 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 names, strengthens, flavours and classifications must be notified at the same time as the parent application 0 Summary of fees and charges as at 1 October 2010 page 1 of 6
2 New Related Product Application (NRPA) s New related product 5,500 Additional names, strengthens, 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 Additional name - Grade 2 1,440 Additional strength 1,440 Additional flavour or type of sweetening 1,440 New Medicine Application Provisional Consent s Application for provisional consent to distribute a new medicine 8,437 Application for renewal of provisional consent 500 Changed Medicine Notifications (CMN) s 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 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 Active ingredient manufacturing process - Grade 1, Type 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 Active ingredient manufacturing process - Grade 3, Type Active ingredient specifications/test methods - Grade Active ingredient specifications/test methods - Grade Active ingredient specifications/test methods - Grade Active ingredient specifications/test methods - Grade 4, Type Active ingredient specifications/test methods - Grade 4, Type 2 1,440 Excipient Excipient specifications/test methods - Grade Excipient specifications/test methods - Grade Excipient specifications/test methods - Grade Summary of fees and charges as at 1 October 2010 page 2 of 6
3 Finished product Finished product packing site - Grade 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 Finished product specifications/test methods - Grade Finished product specifications/test methods - Grade Finished product specifications/test methods - Grade Finished product specifications/test methods - Grade 5, Type Finished product specifications/test methods - Grade 5, Type 2 1,440 Product stability and packaging Shelf life/storage conditions - Grade Shelf life/storage conditions - Grade 2 1,440 Container/closure/packaging - Grade Container/closure/packaging - Grade 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 Indications/dosage - Grade Contraindications, Warnings and Precautions 2,880 Data sheet Data sheet - miscellaneous changes 360 Labelling Labelling - Grade Labelling - Grade Labelling - Grade Other Sponsor 360 Self-assessable change(s) 360 Administration 360 Summary of fees and charges as at 1 October 2010 page 3 of 6
4 Biological or Biotechnological Medicine (CMN Form B) 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. Product name Product name, for each new name 720 Formulation/Excipients Formulation - Grade 1 2,880 Formulation - Grade 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 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 Indications and dosage Indications/dosage - Grade 1 2,880 Indications/dosage - Grade 2 2,880 Indications/dosage - Grade 3 2,880 Indications/dosage - Grade Indications/dosage - Grade Contraindications, Warnings and Precautions 2,880 Labelling Labelling - Grade Labelling - Grade Labelling - Grade Data Sheet Data sheet - miscellaneous changes 360 Other Sponsor 360 Self-assessable change(s) 360 Administration 360 Summary of fees and charges as at 1 October 2010 page 4 of 6
5 Change Related Product Notification (CRPN) s 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. 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 Active ingredient specifications/test methods - Grade Finished product Finished product packing site 720 Finished product manufacturing site - Grade 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 Shelf life/storage conditions - Grade 2 1,440 Container/closure/packaging - Grade Container/closure/packaging - Grade 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 Labelling Labelling - Grade Labelling - Grade Other Sponsor 360 Self-assessable change(s) 360 Administration 360 Summary of fees and charges as at 1 October 2010 page 5 of 6
6 Clinical Trial Application s 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 s 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) Auditing of Non-Licensed Manufacturers - $138 per hour, plus $50 Admin fee, plus disbursements Summary of fees and charges as at 1 October 2010 page 6 of 6
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