Summary of fees and charges at 1 July 2012

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29 August 2012

Version history

Version	Description of change	Author	Effective date
V1.0	Original publication replacing Summary of fees and charges at 1 July 2011	Office of Corporate Services	01/07/2012
V1.1	Update fees and charges replacing Summary of fees and charges at 1 July 2012	Office of Corporate Services	18/07/2012
V1.2	To include fees imposed under MRAs TGA has with other regulators	Office of Corporate Services	29/08/2012

Prescription medicines
Non prescription medicines
Listed medicines
Blood, blood components, and human tissues
Registered devices
Listed devices
Included devices
IVD devices
Good manufacturing practice (GMP)
Miscellaneous
Low value low volume (LVLV) exemptions
Advertising
Biologicals

Prescription medicines

Prescription medicines registration fees
Registration fees	Application fee $	Evaluation fee $
New Chemical Entity	42,000	168,100
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(i) and 4(aa)(ii)	14,000	56,100
New Chemical Entity of a medicine used as an ancillary medical component of a device (item 4(aa)(iii)	28,000	112,000
Extension of indications	25,000	99,900
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies	8,330	33,300
Extension of indicators of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii)	16,700	66,600
Major variations	16,300	65,000
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing or pre-clinical studies	5,430	21,600
Major variation of a medicine used as an ancillary medical component of a device - documentation mentioned in subparagraphs (i) and (ii)	10,900	43,400
New generic product	16,100	64,100
Additional trade name	2,640	10,600
Minor variations (Change in formulation, composition, design specifications, type of container or change of trade name)	960	3,830
Fees for the evaluation of the quality and/or the non-clinical data of a new chemical entity incorporated as an ancillary component of a medical device of therapeutic device	various	various

Prescription medicines variation fees
Variation fees	Application fee $	Evaluation fee $
Variations to a Register entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, but not included in another fee category. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data	960	3,830
		Fee $
Variations to a Register entry involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information.		4,790
Variations to a Register entry (requiring changes to Product Information) with no evaluation of data 'minor editorial changes'		1,480
'Self Assessable Change' with no evaluation of data		1,480
Safety Related Changes with no evaluation of data		1,480
Testing and provision of advice, requested from Pharmaceutical Benefits Program, prior to listing on Pharmaceutical Benefits Listing Program (*this item is inclusive of GST)		1,930 (2,123*)

Prescription medicines administrative charges
Administrative charges	Fee $
Correction of a Register entry	1,480

Prescription medicines annual charges
Annual charges	Fee $
Biological Medicines (Biologics)	6,250
Non-Biologics	3,750

Prescription medicines clinical trials
Clinical trials	Fee $
CTX 30 Days	1,520
CTX 50 Days	18,900
CTN	310
CTN - more than one trialing body	310

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Non prescription medicines

This fee table represents the fees for the registration of both:

Over the counter medicines
Non prescription (complementary) medicines

Non prescription medicines registration fees
Registration of Non prescription medicines		Fee $
Application fee		1,370
Additional /concurrent application fee		600
Processing fee (variation to an existing registration)		1,370
Annual charge		1,280

Non prescription medicines evaluation fees without clinical or toxicological data
Evaluation fees if the documentation does not contain Clinical or Toxicological data - per submission	Fee $
New registered medicine	9,170
Variation	3,310
New substance: such as sunscreen excipients and complementary medicine substances	9,170

Non prescription medicines evaluation fees with clinical or toxicological data
Evaluation fees based on total page count(s) of Clinical or Toxicological data per submission		Fee $
New product	1-50	9,170
	51-250	11,800
	251-500	16,100
	501-1000	24,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,100
Variations	1-50	3,310
	51-250	11,800
	251-500	16,100
	501-1000	21,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,100
New substance	1-50	9,170
	51-250	11,800
	251-500	16,100
	501-1000	21,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,100
Multiple new excipients in listed or registered good for dermal use	1-50	9,170
	51-250	11,800
	251-500	16,100
	501-1000	21,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,100
Assessment of safety and efficacy	1-50	9,170
	51-250	11,800
	251-500	16,100
	501-1000	21,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,400

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Listed medicines

Listed medicines
Listed medicines (including complementary medicines and sunscreens)	Fee $
Application fee	720
Processing fee (variation to an existing listing)	360
Annual charge	910

Listed medicines evaluation fees
Evaluation fees based on total page count(s) of clinical or toxicological data per submission		Fee $
New Listable medicines substance	1-50	9,170
	51-250	11,800
	251-500	16,100
	501-1000	21,400
	1001-2000	32,100
	2001-3000	42,800
	>3000	64,100
Assessment of safety information or documents submitted pursuant to Section 31 of the Therapeutic Goods Act 1989		6,980

Listed medicines - export only
Listed medicines - export only	Fee $
Application fee	720
Processing fee (variation to an existing listing)	360

Listed medicines - export certificates
Listed medicines - export certificates		Fee $
Certificate of Pharmaceutical Product		140
Certificate of Listed Product		140
Certificate of Exempt Product		140

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Blood, blood components and human tissues

Blood, blood components and human tissues
Evaluation fees - per submission		Fee $
Page counts - Blood Plasma Master File & Blood Technical Master File	1-10	1,150
	11-50	9,920
	51-100	22,100
	101-1000	29,600
	1001-3000	46,300
	3001-4000	61,500
	> 4000	74,900

Blood and blood components, except haematopoietic progenitor cells
GMP audit of manufacturers of blood and blood components except haematopoietic progenitor cells	Hourly rate per auditor $
GMP audit of primary site	790
GMP audit of site other than primary site	580
Annual licence charge	Fee $
Primary site	140,600
Additional fixed site (non-mobile)	6,920

Haematopoietic progenitor cells
GMP audit of manufacturers of haematopoietic progenitor cells	Hourly rate per auditor $
GMP audit fee	580
Annual licence charge	Fee $
Manufacturing premises	6,050

Human tissues
GMP audit of manufacturers of human tissues	Hourly rate per auditor $
GMP audit fee	850
Annual licence charge	Fee $
Single step and single human tissue	6,050
Two or more steps	11,800

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Registered devices

Registered devices
Registered devices	Fee $
Application fee - high level registration	3,820
Additional/concurrent - high level registration	1,910
Application fee - low level registration	1,280
Additional/concurrent - low level registration	640
Processing fee - high level registration (variation to an existing registration)	390
Processing fee - low level registration (variation to an existing registration)	390
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants	1,440
Annual charge	2,520

Registered devices clinical trials
Device clinical trials	Fee $
CTN	310
Clinical trial - other	2,400
Clinical trial - Schedule 3 Part 1 Item 3	15,900

Registered devices evaluation fees
Evaluation fees	Initial application fee $	Concurrent application fee $	Abridged application fee $
High Level Registration - type of data
Design/materials/testing	28,100	4,790	9,580
Manufacture/quality control	19,100	4,790	7,970
Biocompatibility/pre-clinical	19,100	4,790	7,970
Human clinical	32,100	4,790	32,100
Software	19,100	4,790	7,700
Confirmatory review of clinical information	N/A	N/A	7,710
Confirmatory review of overseas evaluation report	19,100	4,790	7,710
Low Level Registration - type of data
Design/materials/testing	4,790	N/A	N/A
Manufacture/quality control	4,790	N/A	N/A
Biocompatibility/pre-clinical	4,790	N/A	N/A
Human clinical	4,790	N/A	N/A
Software	4,790	N/A	N/A
Diagnostic Goods Control Reagent	4,790	N/A	N/A
Disinfectants and diagnostic goods for in vitro use	15,900	N/A	N/A
Variation - High Level Registration - type of data
Design/materials/testing	9,580	1,750	N/A
Manufacture/quality control	7,970	1,750	N/A
Biocompatibility/pre-clinical	7,970	1,750	N/A
Human clinical	32,100	1,750	N/A
Software	7,970	1,750	N/A
Confirmatory review of clinical information	7,970	N/A	N/A
Confirmatory review of overseas evaluation report	7,970	1,750	N/A
Variation - Low Level Registration - type of data
Design/materials/testing	1,280	N/A	N/A
Manufacture/quality control	1,280	N/A	N/A
Biocompatibility/pre-clinical	1,280	N/A	N/A
Human clinical	1,280	N/A	N/A
Software	1,280	N/A	N/A
Diagnostic Goods Control Reagent	1,280	N/A	N/A
Disinfectants and diagnostic goods for in vitro use	3,210	N/A	N/A

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Listed devices

Listed devices
Listed devices	Fee $
Application fee	390
Processing fee (variation to an existing listing)	390
Application for exemption under Section 14	410
Annual charge	1,280
Annual charge - therapeutic devices such as IVDs, tampons and disinfectants	730

Listed devices evaluation fees
Evaluation fees	Fee $
Evaluation for assessing whether a listable or listed device is safe for the purposes for which it is to be used	15,900

Listed devices - export only
Listed devices - export only	Fee $
Application fee	390
Processing fee (variation to an existing listing)	390

Listed devices - export certificates
Listed devices - export certificates	Fee $
Export Certificate for listed/listable device	140

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Included devices

Included devices
Medical devices - annual charges	Fee $
(a) Class AIMD medical device	1,150
(b) Class III medical device	1,150
(c) Class IIb medical device	890
(d) Class IIa medical device	890
(e) Class I medical device - sterile	580
(f) Class I medical device - measuring function	580
(g) Other Class I medical device	70

Included devices - conformity assessment - all procedures
Conformity Assessment - all procedures	Fee $
Application for Conformity Assessment Certificate - all procedures	870

Included devices - conformity assessment - initial assessment
Conformity Assessment - initial assessment	Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or	26,000
(b) Schedule 3, clause 1.6 - Design Examination; or	51,200
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or	35,700
(d) Schedule 3, Part 3 - Verification (including management of testing, analysis, and reporting on verification tests); or	24,900
(e) Schedule 3, Part 4 - Production Quality Management System Audit; or	22,700
(f) Schedule 3, Part 5 - Product Quality Management System Audit	19,400

Included devices - conformity assessment - changes
Conformity Assessment - changes	Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Audit; or	15,600
(b) Schedule 3, clause 1.6 - Design Examination; or	30,800
(c) Schedule 3, Part 2 - Type Examination (including management of testing, analysis, and reporting on examination of the type); or	21,500
(d) Schedule 3, Part 4 - Production Quality Management System Audit; or	13,600
(e) Schedule 3, Part 5 - Product Quality Management System Audit	11,800

Included devices - conformity assessment - surveillance audits
Conformity Assessment surveillance audits	Fee $
(a) Schedule 3, Part 1 - Full Quality Management System Surveillance Audit; or	7,560
(b) Schedule 3, Part 4 - Production Quality Management System Surveillance Audit	7,560
(c) Schedule 3, Part 5 - Product Quality Management System Surveillance Audit	7,560
Conformity Assessment - review of Certificate	Fee $
(a) Schedule 3, clause 1.6 - Design Examination re-assessment	46,400
(b) Schedule 3, Part 2 - Type Examination re-assessment (including management of testing, analysis, and reporting on examination of the type)	35,700

Included devices - considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate
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	6,170

Included devices - conformity assessment - additional fees
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	$360 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	$360 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

Included devices - conformity assessment - abridged fee
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	3,520
Inclusion in the ARTG - Application for an inclusion in the Register	Fee $
(a) Class AIMD medical device	1,150
(b) Class III medical device	1,150
(c) Class IIb medical device	890
(d) Class IIa medical device	890
(e) Class I medical device - sterile	890
(f) Class I medical device - measuring function	890
(g) Other Class I medical device	N/A

Included devices - Inclusion in the ARTG - Application Audit Assessment
Inclusion in the ARTG - Application Audit Assessment	Fee $
(a) Level 1 - verification of sponsor's application and evidence of conformity	3,360
(b) Level 2 - Level 1 activities plus review of evidence of conformity	6,170
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the Register	6,170
Variation to an ARTG inclusion entry if the entry is incomplete or incorrect	390

Included devices - other fees
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	390
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)	310
Application for approval to use a specified kind of medical device solely for experimental purposes in humans - Clinical Trial eXemption Scheme (CTX)	15,900

IVD devices

IVD devices
IVD devices	Fee $
Application for conformity assessment certificate	870

IVD devices - conformity assessment - initial assessment
Conformity Assessment - initial assessment	Fee $
Schedule 3, Part 1 - Full Quality Management System Audit; or	26,100
Schedule 3, Clause 1.6 - Design Examination; or	55,700
Schedule 3, Clause 1.6 - Design Examination - immunohaematology reagent; or	13,600
Schedule 3, Clause 1.6 - Abridged Design Examination - previously registered IVDs; or	3,280
Schedule 3, Part 2 - Type Examination; or	36,000
Schedule 3, Part 4 - Product Quality Management System Audit	22,900

IVD devices - conformity assessment - review of certificate
Conformity Assessment - review of Certificate	Fee $
Schedule 3, Part 1 - Full Quality Management System Audit; or	26,100
Schedule 3, Clause 1.6 - Design Examination; or	55,700
Schedule 3, Clause 1.6 - Design Examination - immunohaematology reagent; or	13,600
Schedule 3, Clause 1.6 - Abridged Design Examination; or	3,280
Schedule 3, Part 2 - Type Examination; or	36,000
Schedule 3, Part 4 - Product Quality Management System Audit	22,900

IVD devices - conformity assessment - review of certificate for IVD medical devices
Conformity Assessment - review of Certificate for IVD medical devices	Fee $
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4	7,610

IVD devices - Inclusion in the ARTG
Inclusion in the ARTG - application for an inclusion in the Register	Fee $
IVD medical devices, including Class 4 in-house IVDs	890

IVD devices - conformity assessment - additional fees
Conformity Assessment - additional fees	Fee $
Supplementary assessment in addition to assessment mentioned in item 1.2, 1.3, 1.9A or 1.10A	$360 per assessor hour
Application audit assessment for Class 1, Class 2 and Class 3 IVDs	6,010
Initial and annual notification by a laboratory of its in-house IVDs	890
Considering submissions to the Secretary in relation to a proposed suspension of a conformity assessment certificate for an IVD	6,010
Annual charges for IVDs Class 1-4	Nil

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Good manufacturing practice (GMP)

Good manufacturing practice
Good manufacturing practice (GMP)	Fee $
Licence application fee (excluding Biologicals)	890

Good manufacturing practice - Australian manufacturers - GMP audit fee
Australian manufacturers - GMP audit fee^1,2	Hourly rate per Auditor $
All types of therapeutic goods	580

Good manufacturing practice - annual licence charge
Annual Licence Charge^1,3	Fee $
Single step/single medicine/single type of therapeutic device	5,600
In-vitro diagnostic products	5,600
Ingredients or components	5,600
Herbal/homoeopathic medicinal products	5,600
Other types of therapeutic goods, including containers in which therapeutic goods are to be packed	10,900
Note: Not applicable to blood, blood products, and human tissues, which appear on p3. GMP audit fee is payable when an audit is undertaken before a licence is issued. 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.

Good manufacturing practice - overseas manufacturers - GMP audit fee
Overseas manufacturers - GMP audit fee	Hourly rate per Auditor $
All types of therapeutic goods	1,190

Good manufacturing practice - overseas manufacturers - GMP clearance fees
Overseas manufacturers - GMP clearance fees	Fee $
Assessment of GMP evidence (per manufacturer, per site and per sponsor)	340
Obtaining evidence from overseas regulatory agency (per manufacturer, per site and per sponsor)	600
Reinstatement of expired GMP clearance approval (per manufacturer, per site and per sponsor)	1,020
Desk Audit (in-lieu of an overseas GMP audit)	1,820

GMP certificates
GMP Certificates	Fee $
Certificate of GMP Compliance	140
Quality Systems Certificate	140
Mutual Recognition Agreement Certificate	290
Notarised copy of: Original GMP Licence/Certificate of GMP Compliance/Quality Systems Certificate	50

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Miscellaneous

Miscellaneous fees
Miscellaneous	Fee $
ARTG reinstatement application fee - registered medicines or devices - per invoice	580
ARTG reinstatement application fee - listed medicines or devices - per invoice	580
Processing fee for consent under Section 14 to waive compliance with standards for prescription, registered and listed medicines - per application	410
ARTG information - Freedom of Information (FOI) charges apply - contact ARTG for advice
The wholesale turnover level for reduction in the manufacturing licence charge is $81,300

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Low value low volume (LVLV) exemptions

Low value low volume 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 $14,000)	140
The threshold of sales used in calculation of Low Volume Turnover products for exemption of Annual Charges is 15 times that of the Annual Charge

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Advertising

Advertising - 'specified media'
Fees for advertisements in 'specified media' other than 'broadcast media'		Fee $
Advertising processing time less than 1 hour and:	not more than 100 words	210
	more than 100 words	260
	more than 300 words (including advertorial)	410
	minor change to an approved advertisement sought more than 3 months after approval	100
	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	100
Each additional hour or part thereof		180

Advertising - 'broadcast media'
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		1,050
Television Commercial for a retail outlet that is intended to be broadcast on 1 regional station only in that station's regional area		550
Television Advertorial greater than 150 seconds in length		790 for first minute plus 210 per minute or part minute after that
Radio Advertisement including up to 6 variants of the one concept, for the same product		380
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		270
Still Cinema Media including outdoor media:	not more than 100 words	210
	not more than 300 words	260
	more than 300 words	410
	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		180

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Biologicals

Biologicals - annual charges
Annual charges	Fee $
Annual charge for Class 1 biological	580
Annual charge for Class 2,3,4 biological	5,810

Biologicals - application and notification fees
Application and notification fees	Fee $
Application for manufacturing licence	950
Application for variation	950
Application for inclusion of a Class 1,2,3,4 biological	950
Notification fee for a biological (CTN)	300

Biologicals - evaluation fees
Evaluation Fees	Fee $
Evaluation of dossier for a Class 2 biological	63,400
Evaluation of dossier for a Class 3 biological	126,700
Evaluation of dossier for a Class 4 biological	205,900
Variation Class 2	5,810
Minor Variation Class 3 and 4	15,300
Major Variation Class 3 and 4	30,100
Evaluation of an ingredient/component	20,500
Evaluation CTX	22,800

Biologicals - inspection fees
Inspection Fees	Fee $
Domestic initial manufacturing audit	18,900
Domestic subsequent manufacturing audit	14,300
Overseas initial manufacturing audit	18,900
Overseas subsequent manufacturing audit	14,300
Inspection Fee - in addition to initial or subsequent inspection fee outside Australia	580

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Content last updated: Wednesday, 29 August 2012

Content last reviewed: Wednesday, 29 August 2012

Web page last updated: Friday, 19 October 2012

URL: http://www.tga.gov.au/about/fees-120701.htm

About the TGA

Summary of fees and charges at 1 July 2012

Print version

Version history

Contents

Prescription medicines

Non prescription medicines

Listed medicines

Blood, blood components and human tissues

Registered devices

Listed devices

Included devices

IVD devices

Good manufacturing practice (GMP)

Miscellaneous

Low value low volume (LVLV) exemptions

Advertising

Biologicals

Safety information

Consumers

Health professionals

Industry

About the TGA

News room