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Summary of fees and charges

At 1 July 2008

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Printable version of fees & charges at 1 July 2008 (pdf,146kb)

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Prescription medicines

Evaluation Fees Category 1 and 2 Submissions Fee $ - 100% Fee $ - 75%
New Chemical Entity 176,300 132,300
Extension of indications 104,800 78,600
Major variations
  • New strength
  • New dosage form
  • New route of administration
  • Change in patient group
  • Change in dosage
 68,300 51,200
New generic product 67,300 50,600
Additional trade name 11,100 8,320
Minor variations
  • Change in formulation, composition, specifications or container
  • Variations to a Register entry involving the evaluation of chemistry, quality control and manufacturing information, and clinical, pre-clinical or bio-equivalence data, but not included in another fee category
 4,020 3,010
Changes to Product Information involving the evaluation of data 4,020 3,010
Changes to Product Information where no evaluation is required 1,240 930
Changes to Consumer Medicine Information 1,240 930
Evaluation Fees - Other Submissions Fee $
Fees for the evaluation of the quality (chemical, quality control and manufacturing information) and/or the non-clinical (animal toxicology) data of a new chemical entity incorporated as an ancillary component of a medical device of therapeutic device, are each 1/3 of the respective fee for a prescription medicines. various
Variations to a Register entry involving the evaluation of only chemistry, quality control and manufacturing information 4,020
Notification of Self Assessable Changes 1,240
Safety Related Notification 1,240
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST) 1,620
(1,782*)
Administrative charges Fee $
Withdrawal of a submission prior to acceptance of the submission 20% of evaluation fee
to a maximum of $7,130
Withdrawal of a submission after the evaluation process is taken to be complete Full fee
Correction of a Register entry 1,240
Annual Charges Fee $
Biologics 5,250
Non-biologics 3,140
Clinical Trials Fee $
CTX 30 Days 1,280
CTX 50 Days 15,900
CTN 260
CTN - more than one trialing body 260

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Over-the-counter (OTC) medicines

Registration of non-prescription (OTC) medicines Fee $
Application fee 1,090
Additional /concurrent application fee 480
Processing fee (variation to an existing registration) 1,090
Annual charge 1,010
Evaluation fees per submission if the evaluation documentation does not contain Clinical or Toxicological data Fee $
New product 7,230
Variation 2,610
New substance: CMEC, sunscreen excipients, all other 7,230
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New product 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Variations 1-50 2,610
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
New substance 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Multiple new excipients in listed or registered good for dermal use 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Assessment of Safety and Efficacy 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600

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Complementary medicines

Registration of non-prescription (complementary) medicines Fee $
Application fee 1,090
Additional /concurrent application fee 480
Processing fee (variation to an existing registration) 1,090
Annual charge 1,010
Evaluation fees per submission if the evaluation documentation does not contain Clinical or Toxicological data Fee $
New product 7,230
Variation 2,610
New substance: complementary medicines substance, sunscreen excipients, all other 7,230
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New product 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Variations 1-50 2,610
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
New substance 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Multiple new excipients in listed or registered good for dermal use 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Assessment of Safety and Efficacy 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600

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Listed medicines

Listed medicines Fee $
Application fee 560
Processing fee (variation to an existing listing) 280
Annual charge 710
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New Listable Medicines Substance 1-50 7,230
51-250 9,260
251-500 12,700
501-1000 16,900
1001-2000 25,300
2001-3000 33,800
>3000 50,600
Assessment of safety information or documents submitted pursuant to Section 31 of the Therapeutic Goods Act 1989 5,460
 
Listed medicines - export only
Application fee 560
Processing fee (variation to an existing listing) 280
 
Listed medicines - export certificates Fee $
Certificate of Pharmaceutical Product 120
Certificate of Listed Product 120
Certificate of Exempt Product 120

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Blood, blood components and human tissues

Evaluation fees - per submission Fee $
Page counts - Blood Plasma Master File & Blood Technical Master File 1-10 990
11-50 8,500
51-100 18,900
101-1000 25,400
1001-3000 39,700
3001-4000 52,700
> 4000 64,200
GMP Audit of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells Hourly rate per auditor $
GMP audit of primary site 680
GMP audit of site other than primary site 500
Annual Licence Charge Fee $
Primary site 111,400
Additional fixed site (non-mobile) associated with a primary site 5,480
GMP Audit of Manufacturers of Haematopoietic Progenitor Cells Hourly rate per auditor $
GMP audit fee 500
Annual Licence Charge Fee $
Manufacturing premises 4,800
GMP Audit of Manufacturers of Human Tissues Hourly rate per auditor $
GMP audit fee 500
Annual Licence Charge Fee $
Single step and single human tissue 4,800
Two or more steps 9,300

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Registered devices

Registered devices Fee $
Application fee - high level registration 3,280
Additional/concurrent - high level registration 1,640
Application fee - low level registration 1,090
Additional/concurrent - low level registration 560
Processing fee - high level registration (variation to an existing registration) 340
Processing fee - low level registration (variation to an existing registration) 340
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants 1,240
Annual charge 2,170
Device Clinical Trials Fee $
CTN 260
Clinical Trial - other 2,060
Clinical Trial - Schedule 3 Part 1 Item 3 13,700
Evaluation fees Initial Application Fee $ Concurrent Application Fee $ Abridged Application Fee $
High Level Registration - type of data
Design/materials/testing 24,100 4,110 8,210
Manufacture/quality control 16,400 4,110 6,840
Biocompatibility/pre-clinical 16,400 4,110 6,840
Human clinical 27,500 4,110 27,500
Software 16,400 4,110 6,840
Confirmatory review of clinical information N/A N/A 6,840
Confirmatory review of overseas evaluation report 16,400 4,110 6,840
Low Level Registration - type of data
Design/materials/testing 4,110 N/A N/A
Manufacture/quality control 4,110 N/A N/A
Biocompatibility/pre-clinical 4,110 N/A N/A
Human clinical 4,110 N/A N/A
Software 4,110 N/A N/A
Diagnostic Goods Control Reagent 4,110 N/A N/A
Disinfectants and diagnostic goods for in vitro use 13,700 N/A N/A
Variation - High Level Registration - type of data
Design/materials/testing 8,210 1,510 N/A
Manufacture/quality control 6,840 1,510 N/A
Biocompatibility/pre-clinical 6,840 1,510 N/A
Human clinical 27,500 1,510 N/A
Software 6,840 1,510 N/A
Confirmatory review of clinical information 6,840 N/A N/A
Confirmatory review of overseas evaluation report 6,840 1,510 N/A
Variation - Low Level Registration - type of data
Design/materials/testing 1,090 N/A N/A
Manufacture/quality control 1,090 N/A N/A
Biocompatibility/pre-clinical 1,090 N/A N/A
Human clinical 1,090 N/A N/A
Software 1,090 N/A N/A
Diagnostic Goods Control Reagent 1,090 N/A N/A
Disinfectants and diagnostic goods for in vitro use 2,750 N/A N/A

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Listed devices

Listed devices Fee $
Application fee 340
Processing fee (variation to an existing listing) 340
Application for exemption under Section 14 350
Annual charge 1,090
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants 620
Evaluation Fees Fee $
Evaluation for assessing whether a listable or listed device is safe for the purposes for which it is to be used 13,700
 
Listed devices - export only Fee $
Application fee 340
Processing fee (variation to an existing listing) 340
 
Listed devices - export certificates Fee $
Export Certificate for listed/ listable device 120

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Included devices

Conformity Assessment All Procedures Fee $
Application for Conformity Assessment Certificate - All Procedures 740
Medical Devices - Annual Charges Fee $
(a) Class AIMD medical device 990
(b) Class III medical device 990
(c) Class IIb medical device 760
(d) Class IIa medical device 760
(e) Class I medical device - sterile 500
(f) Class I medical device - measuring function 500
(g) Other Class I medical device 60
Conformity Assessment - Initial Assessment Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or 22,200
(b) Schedule 3, clause 1.6 - Design Examination; or 43,900
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or 30,600
(d) Schedule 3, Part 3 - Verification (including management of testing, analysis, and reporting on verification tests); or 21,400
(e) Schedule 3, Part 4 - Production Quality Management System Audit; or 19,500
(f) Schedule 3, Part 5 - Product Quality Management System Audit 16,700
Conformity Assessment - Changes Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or 13,400
(b) Schedule 3, clause 1.6 - Design Examination; or 26,400
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or 18,400
(d) Schedule 3, Part 4 - Production Quality Management System Audit; or 11,700
(e) Schedule 3, Part 5 - Product Quality Management System Audit 10,100
Conformity Assessment Surveillance Audits Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Surveillance Audit; or 6,480
(b) Schedule 3, Part 4 - Production Quality Management System Surveillance Audit 6,480
(c) Schedule 3, Part 5 - Product Quality Management System Surveillance Audit 6,480
Conformity Assessment - Review of Certificate Fee $
(a) Schedule 3, clause 1.6 - Design Examination re-assessment 39,800
(b) Schedule 3, Part 2 - Type Examination re-assessment (including management of testing, analysis, and reporting on examination of the type) 30,600
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate Fee $
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate 5,290
Conformity Assessment - Additional Fees Fee $
Assessment of a medicinal component of a device See Schedule 9 of the TG Regs Items 4, 5(b),(d)
Supplementary assessments to Items 1.2, 1.3, 1.9 or 1.10 $310 per assessor hour
Reasonable travel, accommodation and allowance costs including travel both in and outside Australia At Cost
Assessor preparation for assessments conducted outside Australia $310 per assessor hour
Cost of testing incurred in purchasing, establishing and setting up the equipment to be used to conduct the tests and the direct costs of conducting the tests (including the cost of any consumables used to conduct the tests) At Cost
Conformity Assessment - Abridged Fee Fee $
Conformity assessment where assessment has already been undertaken by the TGA for the EU or EFTA Mutual Recognition Agreement and there is sufficient information to allow the assessment to be abridged 3,010
 
Inclusion in the ARTG - Application for an inclusion in the Register Fee $
(a) Class AIMD medical device 990
(b) Class III medical device 990
(c) Class IIb medical device 760
(d) Class IIa medical device 760
(e) Class I medical device - sterile 760
(f) Class I medical device - measuring function 760
(g) Other Class I medical device Nil
Inclusion in the ARTG - Application Audit Assessment Fee $
(a) Level 1 - verification of sponsor's application and evidence of conformity 2,890
(b) Level 2 - Level 1 activities plus review of evidence of conformity 5,290
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the Register 5,290
Variation to an ARTG inclusion entry if the entry is incomplete or incorrect 340
Other fees Fee $
Application for consent of secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device that does not conform to the Essential Principles 340
Notification of intention to sponsor a clinical trial of a medical device to be used solely for experimental purposes in humans - Clinical Trial Notification Scheme (CTN) 260
Application for approval to use a specified kind of medical device solely for experimental purposes in humans - Clinical Trial eXemption Scheme (CTX) 13,700

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Good manufacturing practice (GMP)

Good manufacturing practice (GMP) Fee $
Licence application fee 760
Australian Manufacturers - GMP Audit Fee1,2 Hourly rate per Auditor $
All types of therapeutic goods 500
Annual Licence Charge1,3 Fee $
Single step/single medicine/single type of therapeutic device 4,800
In-vitro diagnostic products 4,800
Ingredients or components 4,800
Herbal/homeopathic medicinal products 4,800
Other types of therapeutic goods, including containers in which therapeutic goods are to be packed 9,300

Note:

  1. Not applicable to blood, blood products, and human tissues, which appear on p3.
  2. GMP audit fee is payable when an audit is undertaken before a licence is issued.
  3. The following audit hours are included in the annual licence charges:
    • Manufacturers with low level licence charges - total 16 auditor hours in 3 financial years
    • Manufacturers with high level licence charges - total 48 auditor hours in 3 financial years
    GMP audit fee for Australian manufacturers is applicable once the above number of hours is exceeded.
Overseas Manufacturers - GMP Audit Fee Hourly rate per Auditor $
All types of therapeutic goods 1,020
Overseas Manufacturers - GMP Clearance Fees Fee $
Assessment of GMP evidence (per manufacturer, per site and per sponsor) 290
Obtaining evidence from overseas regulatory agency (per manufacturer, per site and per sponsor) 520
Reinstatement of expired GMP clearance approval (per manufacturer, per site and per sponsor) 880
Desk Audit (in-lieu of an overseas GMP audit) 1,550
GMP Certificates Fee $
Certificate of GMP Compliance 120
Quality Systems Certificate 120
Mutual Recognition Agreement Certificate 240
Certified copy of a certificate 40

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Miscellaneous

Miscellaneous Fee $
ARTG reinstatement application fee - registered medicines or devices - per invoice 500
ARTG reinstatement application fee - listed medicines or devices - per invoice 500
Processing fee for consent under Section 14 to waive compliance with standards for prescription, registered and listed medicines - per product/ARTG entry 350
Application for Declaration that Turnover is Low Volume and Low Value - per product ($12,800 max) 120
ARTG information - Freedom of Information (FOI) charges apply - contact ARTG for advice
The percentage of sales used in calculation of low volume and low value products for exemption from Annual Charge is 6.8%
The wholesale turnover level for reduction in the manufacturing licence charge is $73,600

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Advertising

Fees for advertisements in "specified media" other than "broadcast media" Fee $
Advertising processing time less than 1 hour and - not more than 100 words 180
- more than 100 words 220
- more than 300 words (including advertorial) 350
- minor change to an approved advertisement sought more than 3 months after approval 90
- re-approval of an identical advertisement whose approval number has expired 50% of applicable fee
- approval of a variation to an advertisement whose approval number has not expired 50% of applicable fee
- classified advertisement 90
Each additional hour or part thereof 160
Fees for advertisements in "broadcast media" Fee $
Advertising processing time less than 1 hour and
Television or Cinema Commercial up to and including 150 seconds in length with up to 3 variations of the one concept for the one product 900
Television Commercial for a retail outlet that is intended to be broadcast on 1 regional station only in that station's regional area 470
Television Advertorial greater than 150 seconds in length 680 for first minute plus 190 per minute or part minute after that
Radio Advertisement including up to 6 variants of the one concept, for the same product 330
Radio Advertisement that is intended to be broadcast in a regional area only, including up to six variations of the one concept for the same product 230
Still Cinema Media including outdoor media: - not more than 100 words 180
- not more than 300 words 220
- more than 300 words 350
- minor change to an approved advertisement sought more than 3 months after approval 50% of applicable fee
- re-approval of an identical advertisement whose approval number has expired 50% of applicable fee
- approval of a variation to an advertisement whose approval number has not expired 50% of applicable fee
Each additional hour or part thereof 160

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