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Summary of fees and charges

At 10 July 2009

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Printable version of fees & charges at 10 July 2009 (pdf,71kb)

Prescription medicines

Evaluation Fees Category 1 and 2 Submissions Fee $ - 100% Fee $ - 75%
New Chemical Entity 187,900 141,000
Extension of indications 111,700 83,800
Major variations
  • New strength
  • New dosage form
  • New route of administration
  • Change in patient group
  • Change in dosage
 72,800 54,600
New generic product 71,700 53,900
Additional trade name 11,800 8,870
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
 4,290 3,210
Changes to Product Information involving the evaluation of data 4,290 3,210
Changes to Product Information where no evaluation is required 1,320 990
Changes to Consumer Medicines Information 1,320 990
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 4,290
Notification of Self Assessable Changes 1,320
Safety Related Notification 1,320
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST) 1,730
(1,903*)
Administrative Charges Fee $
Withdrawal of a submission prior to acceptance of the submission 20% of evaluation fee
to a maximum of $7,600
Withdrawal of a submission after the evaluation process is taken to be complete Full fee
Correction of a Register entry 1,320
Annual Charges Fee $
Biologics 5,600
Non-biologics 3,350
Clinical Trials Fee $
CTX 30 Days 1,360
CTX 50 Days 16,900
CTN 270
CTN - more than one trialing body 270

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Over-the-counter (OTC) medicines

Registration of non-prescription (OTC) medicines Fee $
Application fee 1,230
Additional /concurrent application fee 540
Processing fee (variation to an existing registration) 1,230
Annual charge 1,140
Evaluation Fees if the documentation does not contain Clinical or Toxicological data - per submission Fee $
New product 8,190
Variation 2,960
New substance: CMEC, sunscreen excipients, all other 8,190
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New product 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Variations 1-50 2,960
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
New substance 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Multiple new excipients in listed or registered good for dermal use 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Assessment of Safety and Efficacy 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300

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Complementary medicines

Registration of non-prescription (complementary) medicines Fee $
Application fee 1,230
Additional /concurrent application fee 540
Processing fee (variation to an existing registration) 1,230
Annual charge 1,140
Evaluation Fees if the documentation does not contain Clinical or Toxicological data - per submission Fee $
New product 8,190
Variation 2,960
New substance: complementary medicines substance, sunscreen excipients, all other 8,190
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New product 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Variations 1-50 2,960
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
New substance 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Multiple new excipients in listed or registered good for dermal use 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Assessment of Safety and Efficacy 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300

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Listed medicines

Listed medicines Fee $
Application fee 640
Processing fee (variation to an existing listing) 320
Annual charge 810
Evaluation Fees based on total page count(s) of Clinical or Toxicological data per submission Fee $
New Listable Medicines Substance 1-50 8,190
51-250 10,500
251-500 14,400
501-1000 19,100
1001-2000 28,700
2001-3000 38,300
>3000 57,300
Assessment of safety information or documents submitted pursuant to Section 31 of the Therapeutic Goods Act 1989 6,240
 
Listed medicines - export only
Application fee 640
Processing fee (variation to an existing listing) 320
 
Listed medicines - export certificates Fee $
Certificate of Pharmaceutical Product 130
Certificate of Listed Product 130
Certificate of Exempt Product 130

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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 1,030
11-50 8,870
51-100 19,700
101-1000 26,500
1001-3000 41,400
3001-4000 55,000
> 4000 67,000
GMP Audit of Manufacturers of Blood and Blood Components except Haematopoietic Progenitor Cells Hourly rate per auditor $
GMP audit of primary site 710
GMP audit of site other than primary site 520
Annual Licence Charge Fee $
Primary site 125,700
Additional fixed site (non-mobile) associated with a primary site 6,180
GMP Audit of Manufacturers of Haematopoietic Progenitor Cells Hourly rate per auditor $
GMP audit fee 520
Annual Licence Charge Fee $
Manufacturing premises 5,410
GMP Audit of Manufacturers of Human Tissues Hourly rate per auditor $
GMP audit fee 520
Annual Licence Charge Fee $
Single step and single human tissue 5,410
Two or more steps 10,500

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Registered devices

Registered devices Fee $
Application fee - high level registration 3,420
Additional/concurrent - high level registration 1,710
Application fee - low level registration 1,140
Additional/concurrent - low level registration 580
Processing fee - high level registration (variation to an existing registration) 350
Processing fee - low level registration (variation to an existing registration) 350
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants 1,290
Annual charge 2,260
Device Clinical Trials Fee $
CTN 270
Clinical Trial - other 2,150
Clinical Trial - Schedule 3 Part 1 Item 3 14,300
Evaluation fees Initial Application Fee $ Concurrent Application Fee $ Abridged Application Fee $
High Level Registration - type of data
Design/materials/testing 25,100 4,290 8,560
Manufacture/quality control 17,100 4,290 7,130
Biocompatibility/pre-clinical 17,100 4,290 7,130
Human clinical 28,700 4,290 28,700
Software 17,100 4,290 7,130
Confirmatory review of clinical information N/A N/A 7,130
Confirmatory review of overseas evaluation report 17,100 4,290 7,130
Low Level Registration - type of data
Design/materials/testing 4,290 N/A N/A
Manufacture/quality control 4,290 N/A N/A
Biocompatibility/pre-clinical 4,290 N/A N/A
Human clinical 4,290 N/A N/A
Software 4,290 N/A N/A
Diagnostic Goods Control Reagent 4,290 N/A N/A
Disinfectants and diagnostic goods for in vitro use 14,300 N/A N/A
Variation - High Level Registration - type of data
Design/materials/testing 8,560 1,570 N/A
Manufacture/quality control 7,130 1,570 N/A
Biocompatibility/pre-clinical 7,130 1,570 N/A
Human clinical 28,700 1,570 N/A
Software 7,130 1,570 N/A
Confirmatory review of clinical information 7,130 N/A N/A
Confirmatory review of overseas evaluation report 7,130 1,570 N/A
Variation - Low Level Registration - type of data
Design/materials/testing 1,140 N/A N/A
Manufacture/quality control 1,140 N/A N/A
Biocompatibility/pre-clinical 1,140 N/A N/A
Human clinical 1,140 N/A N/A
Software 1,140 N/A N/A
Diagnostic Goods Control Reagent 1,140 N/A N/A
Disinfectants and diagnostic goods for in vitro use 2,870 N/A N/A

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Listed devices

Listed devices Fee $
Application fee 350
Processing fee (variation to an existing listing) 350
Application for exemption under Section 14 370
Annual charge 1,140
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants 650
Evaluation Fees Fee $
Evaluation for assessing whether a listable or listed device is safe for the purposes for which it is to be used 14,300
 
Listed devices - export only Fee $
Application fee 350
Processing fee (variation to an existing listing) 350
 
Listed devices - export certificates Fee $
Export Certificate for listed/ listable device 130

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Included devices

Conformity Assessment All Procedures Fee $
Application for Conformity Assessment Certificate - All Procedures 770
Medical Devices - Annual Charges Fee $
(a) Class AIMD medical device 1,030
(b) Class III medical device 1,030
(c) Class IIb medical device 790
(d) Class IIa medical device 790
(e) Class I medical device - sterile 520
(f) Class I medical device - measuring function 520
(g) Other Class I medical device 60
Conformity Assessment - Initial Assessment Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or 23,200
(b) Schedule 3, clause 1.6 - Design Examination; or 45,800
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or 31,900
(d) Schedule 3, Part 3 - Verification (including management of testing, analysis, and reporting on verification tests); or 22,300
(e) Schedule 3, Part 4 - Production Quality Management System Audit; or 20,300
(f) Schedule 3, Part 5 - Product Quality Management System Audit 17,400
Conformity Assessment - Changes Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or 14,000
(b) Schedule 3, clause 1.6 - Design Examination; or 27,500
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or 19,200
(d) Schedule 3, Part 4 - Production Quality Management System Audit; or 12,200
(e) Schedule 3, Part 5 - Product Quality Management System Audit 10,500
Conformity Assessment Surveillance Audits Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Surveillance Audit; or 6,760
(b) Schedule 3, Part 4 - Production Quality Management System Surveillance Audit 6,760
(c) Schedule 3, Part 5 - Product Quality Management System Surveillance Audit 6,760
Conformity Assessment - Review of Certificate Fee $
(a) Schedule 3, clause 1.6 - Design Examination re-assessment 41,500
(b) Schedule 3, Part 2 - Type Examination re-assessment (including management of testing, analysis, and reporting on examination of the type) 31,900
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 5,520
Conformity Assessment - Additional Fees Fee $

Assessment of a medicinal component of a device*

*(Refer to Items 4(bb), 5(b), and 5(d) of Part 2 of Schedule 9 of the Therapeutic Goods Regulations 1990)

 As per TG Regs Items 4(bb), 5(b), and 5(d)
Supplementary assessments to Items 1.2, 1.3, 1.9 or 1.10 $320 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 $320 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 3,140
 
Inclusion in the ARTG - Application for an inclusion in the Register Fee $
(a) Class AIMD medical device 1,030
(b) Class III medical device 1,030
(c) Class IIb medical device 790
(d) Class IIa medical device 790
(e) Class I medical device - sterile 790
(f) Class I medical device - measuring function 790
(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 3,010
(b) Level 2 - Level 1 activities plus review of evidence of conformity 5,520
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the Register 5,520
Variation to an ARTG inclusion entry if the entry is incomplete or incorrect 350
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 350
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) 270
Application for approval to use a specified kind of medical device solely for experimental purposes in humans - Clinical Trial eXemption Scheme (CTX) 14,300

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Good manufacturing practice (GMP)

Good manufacturing practice (GMP) Fee $
Licence application fee 790
Australian Manufacturers - GMP Audit Fee1,2 Hourly rate per Auditor $
All types of therapeutic goods 520
Annual Licence Charge1,3 Fee $
Single step/single medicine/single type of therapeutic device 5,010
In-vitro diagnostic products 5,010
Ingredients or components 5,010
Herbal/homeopathic medicinal products 5,010
Other types of therapeutic goods, including containers in which therapeutic goods are to be packed 9,700

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 1,060
Overseas Manufacturers - GMP Clearance Fees Fee $
Assessment of GMP evidence (per manufacturer, per site and per sponsor) 300
Obtaining evidence from overseas regulatory agency (per manufacturer, per site and per sponsor) 540
Reinstatement of expired GMP clearance approval (per manufacturer, per site and per sponsor) 920
Desk Audit (in-lieu of an overseas GMP audit) 1,620
GMP Certificates Fee $
Certificate of GMP Compliance 130
Quality Systems Certificate 130
Mutual Recognition Agreement Certificate 250
Certified copy of a certificate 40

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Miscellaneous

Miscellaneous Fee $
ARTG reinstatement application fee - registered medicines or devices - per invoice 520
ARTG reinstatement application fee - listed medicines or devices - per invoice 520
Processing fee for consent under Section 14 to waive compliance with standards for prescription, registered and listed medicines - per product/ARTG entry 370
ARTG information - Freedom of Information (FOI) charges apply - contact ARTG for advice
The wholesale turnover level for reduction in the manufacturing licence charge is $76,800

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Low value low volume (LVLV) exemptions

Low value low volume (LVLV) exemptions Fee $
Application fee for Declaration that Annual Turnover is of Low Value and Low Volume – per product (to a maximum of $13,000) 130
The percentage of sales used in calculation of low volume and low value products for exemption from Annual Charge is 6.8%

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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
 190
  • more than 100 words
 230
  • more than 300 words (including advertorial)
 370
  • 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 170
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 940
Television Commercial for a retail outlet that is intended to be broadcast on 1 regional station only in that station's regional area 490
Television Advertorial greater than 150 seconds in length 710 for first minute plus 200 per minute or part minute after that
Radio Advertisement including up to 6 variants of the one concept, for the same product 340
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 240
Still Cinema Media including outdoor media:
  • not more than 100 words
 190
  • not more than 300 words
 230
  • more than 300 words
 370
  • 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 170

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