Fees and charges: summary - from 4 December 2017

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The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.

  • A fee is charged for a service, such as a product evaluation.
  • A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year.

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This is a summary of fees and charges, which are in the Australian therapeutic goods legislation. For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.

Prescription medicines

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These fees apply to prescription medicines and other medicines that are evaluated as prescription medicines.

For clinical trials supplying unapproved medicines, go to Clinical trials.

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Type of prescription medicine Charge Regulation
Biological medicine $6,990 3(1)(b) and 3(1A)(b)
Non-biological medicine (chemical entity) - higher amount $3,980 4(9)
Non-biological medicine (chemical entity) - lower amount $3,230 4(9)

More about annual charges for non-biological medicines (chemical entities)

Higher annual charges

Regulation 4 of the Therapeutic Goods (Charges) Regulations 1990 states when the higher annual charge applies for prescription medicine chemical entities.

Briefly, for prescription medicine chemical entities, a higher annual charge applies:

  1. for medicines containing at least one specified active ingredient, whatever the duration of registration:
    • thalidomide
    • leflunomide
    • lenalidomide
    • mifepristone
    • clozapine
    • isotretinoin
  • until eight years have passed since registration, following an application for:
    • new chemical entity
    • extension of indications
    • change to intended patient group

Annual charges following applications for other major variations will incur higher or lower charges depending on the parent good, for example:

  • new formulation
  • change of strength
  • new dosage forms.

Lower annual charges

The lower annual charge applies for:

  • most generic prescription medicines
  • most prescription medicines that are not biological medicines past the eighth anniversary of an application approval for a new chemical entity, extension of indications or change to intended patient group.

Prescription medicine application and evaluation fees

These applications have both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Prescription medicine application type Application fee Evaluation fee Item in Schedule 9, Part 2
Priority designation of a prescription medicine $12,300 n/a Item 1B
New chemical entity $46,900 $188,200 Items 2(ba) and 4(a)
New chemical entity in the priority pathway $49,800 $199,000 Items 2(bca) and 4(ab)
Extension of indications $28,000 $111,700 Items 2(bd) and 4(b)
Extension of indications in the priority pathway $29,600 $118,400 Items 2(bfa) and 4(bd)
Major variations $18,300 $72,800 Items 2(bi) and 4(g)
Minor variation applications applied for under section 23 of the Act (Change in formulation, composition, design specifications, type of container or change of trade name) $1,080 $4,280 Items 2(bj) and 4(h)
Variations to an ARTG entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, applied for under 9D(3) of the Act. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data. $1,080 $4,280 Items 2AC and 2C
Additional trade name $2,960 $11,900 Items 2(bh) and 4(d)
New generic product $18,100 $71,800 Items 2(bg) and 4(c)
Extension of indications of a generic medicine to maintain currency with indications already registered to the corresponding innovator product and where clinical and/or bioequivalence data are not required $1,080 $4,270 Items 2(bk) and 4(bc)

n/a: not applicable; 'The Act' refers to the Therapeutic Goods Act 1989.

Requests with single fee

These requests have a single fee, instead of an application fee and an evaluation fee. These fees are in Schedule 9, 'Therapeutic Goods Regulations 1990'.

Prescription medicine request Fee Item in Schedule 9, Part 2
Variations to an ARTG entry, applied for under section 9D(3) of the Act, 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. $5,360 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,650 Item 2A(a)
Notification request $780 Item 2CB
Correction to an ARTG entry $1,650 Item 2A(a)
Self-assessable request with no evaluation of data $1,650 Item 2A(a)
Safety-related request with no evaluation of data $1,650 Item 2A(a)
Safety-related request with evaluation of data $5,360 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,170 Item 18
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $460 Item 1A

'The Act' refers to the Therapeutic Goods Act 1989.

Medicines as components of devices

This table applies to prescription medicines used as an ancillary component of a medical device. Items refer to Schedule 9, Therapeutic Goods Regulations 1990.

Application type Application fee Evaluation fee Item in Schedule 9, Part 2
New chemical entity of a medicine used as an ancillary medical component of a device $15,600 $62,800 Items 2(bb), 4(aa)(i), 4(aa)(ii)
New chemical entity of a medicine used as an ancillary medical component of a device $31,300 $125,200 Items 2(bc), 4(aa)(iii)
Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $9,310 $37,200 Items 2(be)(i), 4(bb)(i)(a), 4(bb)(ii)(a)
Extension of indications of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $18,700 $74,400 Items 2(bf)(i), 4(bb)(iii)(a)
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $6,070 $24,100 Items 2(be)(ii), 4(bb)(i)(b), 4(bb)(ii)(b)
Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $12,200 $48,700 Items 2(bf)(ii), 4(bb)(iii)(b)

Non-prescription medicines

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Non-prescription medicines include complementary medicines, sunscreens and over-the-counter (OTC) medicines.

For clinical trials supplying unapproved non-prescription medicines, go to Clinical trials.

Listed medicines

Listed medicines include listed complementary medicines and sunscreens.

For listed export-only medicines go to Export.

Listed medicine fee or charge Amount Legislation
Annual charge $1,020 Therapeutic Goods (Charges) Regulations 1990, regulations 3(1)(c)(i) and 3(1A)(c)(i)
Application fee $800 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 3(b)
Processing fee (variation to an existing listing) $410 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 2A(c)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A
'The Act' refers to the Therapeutic Goods Act 1989.

New substances

There is no application fee for a new substance.

The evaluation fees below apply to:

  • a new substance for listed medicines
  • a new substance for registered non-prescription medicines
  • multiple new excipients in listed or registered non-prescription medicines for dermal use.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Pages of nonclinical and clinical data Evaluation fee Item in Schedule 9 Part 2
0-50 $10,300 Items 7A(a), 7A(b)(i), 7B(a), 7B(b)(i)
51-250 $13,200 Items 7A(b)(ii), 7B(b)(ii)
251-500 $18,100 Items 7A(b)(iii), 7B(b)(iii)
501-1000 $23,900 Items 7A(b)(iv), 7B(b)(iv)
1001-2000 $35,900 Items 7A(b)(v), 7B(b)(v)
2001-3000 $47,900 Items 7A(b)(vi), 7B(b)(vi)
>3000 $71,800 Items 7A(b)(vii), 7B(b)(vii)

Registered complementary medicines

Refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) for information on the data package required for an application for a registered complementary medicine.

Charges and application, notification and processing fees

Type of fee or charge Amount Legislation
Annual charge $1,430 Regulation 3(1)(a)(i), Therapeutic Goods (Charges) Regulations 1990
Application fee $1,530 Item 2(a), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Additional or concurrent application fee $680 Item 2(f), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Processing fee for variation $1,530 Item 2A(b), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Notification requests $780 Items 2CC and 2CB, Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A, Part 2, Schedule 9, Therapeutic Goods Regulations 1990

Evaluation fees for registered complementary medicines

These evaluation fees are for registered complementary medicines. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Pages of nonclinical and clinical data Evaluation fee Item in Schedule 9 Part 2
0-50 pages for a new product $10,300 Items 5(a) and 5(b)(i)
0-50 pages for a variation under section 9D(1), 9D(2) or 9D(3) of the Therapeutic Goods Act 1989 $3,710 Items 5(c) and 5(d)(i)
51-250 $13,200 Items 5(b)(ii) and 5(d)(ii)
251-500 $18,100 Items 5(b)(iii) and 5(d)(iii)
501-1000 $23,900 Items 5(b)(iv) and 5(d)(iv)
1001-2000 $35,900 Items 5(b)(v) and 5(d)(v)
2001-3000 $47,900 Items 5(b)(vi) and 5(d)(vi)
>3000 $71,800 Items 5(b)(vii) and 5(d)(vii)

Registered OTC medicines

For guidance on OTC applications, go to Australian regulatory guidelines for OTC medicines.

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Medicine type Charge Regulation
Registered OTC medicine $1,430 Regulations 3(1)(a)(i) and 3(1A)(a)(i)

New registered OTC medicine applications

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Application fee Evaluation fee Item in Schedule 9 Part 3
N1 application $1,590 $3,930 Items 1(a) and 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $790 $3,930 Items 3(d) and 2(a)
N2 application $1,590 $5,570 Items 1(b) and 2(b)
N2 concurrent application per additional application (as described in item 3 of Part 3 Schedule 9 of the Regulations) $790 $5,570 Items 3(e) and 2(b)
N3 application $2,550 $8,590 Items 1(c) and 2(c)
N3 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Item 3(f) and 4(d)
N4 application $3,720 $14,200 Items 1(d)and 2(d)
N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Items 3(g)and 4(e)
N5 application $5,520 $21,100 Items 1(e) and 2(e)
N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Items 3(h) and 4(f)

Changes: applications under section 23

For applications to change registered OTC medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for C2, C3 and C4 applications.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Application fee Evaluation fee Item in Schedule 9 Part 3
C1 (section 23) application $1,590 n/a Item 1(f)
C2 (section 23) application $1,590 $3,930 Items 1(g) and 2(f)
C3 (section 23) application $1,590 $6,580 Items 1(h) and 2(g)
C4 (section 23) application $2,550 $8,590 Items 1(i) and 2(h)

n/a: not applicable

Changes: applications under section 9D

For applications to change registered OTC medicines made under section 9D of the Therapeutic Goods Act 1989, there is a fee and a refund if no evaluation occurs for C2, C3 and C4 applications.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Upfront fee Refund if no evaluation Therapeutic Goods Regulations 1990
CN (section 9D) notification request $780 n/a Schedule 9 Part 2 items 2CD and 2CB
C1 (section 9D) application $1,590 n/a Schedule 9 Part 3 Item 5
C2 (section 9D) application $5,520 $3,930

Schedule 9 Part 3 Item 6(a)

Regulation 43AC (2)(a)

C3 (section 9D) application $8,170 $6,580

Schedule 9 Part 3 Item 6(b)

Regulation 43AC (2)(b)

C4 (section 9D) application $11,140 $8,590

Schedule 9 Part 3 Item 6(c)

Regulation 43AC (2)(c)

n/a: not applicable

Other fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Registered OTC medicine request Fee Item in Schedule 9 Part 3
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data $1,560 Item 7(a)
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed $7,990 Item 7(b)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A

The 'Act' refers to the Therapeutic Goods Act 1989.

Manufacturing medicines and OTGs

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The section applies to the manufacture of:

  • all medicines
  • other listed and registered therapeutic goods (OTGs).

Annual charges: manufacturing licences

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Annual charges for manufacturing licences Charge Therapeutic Goods (Charges) Regulations 1990
Low level manufacturing licence charge $6,260 Regulation 3(2)(c-h)
High level manufacturing licence charge $12,200 Regulation 3(2)(a)(b)

Only one charge applies and that is the greatest applicable charge [regulation 3(3) Therapeutic Goods (Charges) Regulations 1990].

Manufacturing inspections

Australian manufacturing licences

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Fees related to Australian manufacturing licences Fee Item in Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,000 Item 8
Australian manufacturing sites - inspection fee $660/hour/inspector Item 9(a)

Overseas manufacturing site inspections

There is no application fee for GMP certification of overseas manufacturing sites.

Overseas manufacturing site inspections Fee
Overseas manufacturing sites - inspection fee $1,330/hour/inspector
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia costs and reasonable expenses

GMP clearance fees

There is no application fee for GMP clearance. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

GMP clearance of overseas manufacturers Fee Item in Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $390 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $680 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,030 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,140 Item 6AC

Issuing manufacturing certificates

Certificate Fee
Certificate of GMP compliance $170
Mutual Recognition Agreement certificate $320

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$60

Export

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The Therapeutic Goods Act 1989 applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia.

Medicine export certificates

You can apply for an export certificate for any medicine. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Certificate type Fee Item in Schedule 9 Part 2
Certificate of pharmaceutical product $170 Item 10
Certificate of listed product $170 Item 10
Certificate of exempt product $170 Item 10

Listed export-only medicines

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Export only applications Fee Item in Schedule 9 Part 2
Application fee $800 Item 3(b)
Processing fee (variation to an existing listing) $410 Item 2A(c)

Device export certificates

You can apply for an export certificate for a medical device (including IVD devices) or OTG. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Certificate type Fee Item in Schedule 9 Part 2
Certificate of free sale $170 Item 10
Export certificate $170 Item 10

Biologicals

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Below are the fees and annual charges for manufacturing and sponsoring biologicals.

The Australian Regulatory Guidelines for Biologicals (ARGB) provide information on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals').

For clinical trials supplying unapproved biologicals, go to Clinical trials.

Manufacturing biologicals: annual charges

There is no annual charge for a manufacturer who only manufactures biologicals [regulation 3(2)(m) Therapeutic Goods (Charges) Regulations 1990].

Manufacturing biologicals: fees

These fees are in Schedule 9A, Therapeutic Goods Regulations 1990.

Manufacturing biologicals Fee Item in Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,070 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,100 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,000 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $660/hour/inspector Item 14
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia costs and reasonable expenses Item 15

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

ARTG inclusion of biologicals Amount Therapeutic Goods (Charges) Regulations
Class 1 biological annual charge for ARTG inclusion $660 Regulation 3(1AA)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,500 Regulation 3(1AA)(b)

These fees are in Schedule 9A, Therapeutic Goods Regulations 1990.

Sponsoring biologicals Fee Item in Schedule 9A Part 2
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $23,000 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,070 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,070 Item 2
Variation application fee - all classes $1,070 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $70,900 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,500 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $141,700 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $230,300 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $33,600 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,100 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,500 Item 8A

Blood, blood components and HPCs

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Below are the fees and annual charges for human blood, blood components, haematopoietic progenitor cells (HPC) and human tissues not regulated as biologicals.

Manufacturing annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Therapeutic good being manufactured Charge Therapeutic Goods (Charges) Regulations 1990
Blood and blood components (not HPCs) - primary manufacturing site $157,300 Regulation 3(2)(j)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $7,740 Regulation 3(2)(j)(ii)
HPCs manufacturing site $6,770 Regulation 3(2)(ja)

Only one charge applies and that is the greatest applicable charge [regulation 3(3) Therapeutic Goods (Charges) Regulations 1990].

Manufacturing fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Manufacturing fees Fee Item in Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,000 Item 8
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $880/hour/inspector Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $660/hour/inspector Item 9AC
HPCs - Australian manufacturing site inspection fee $660/hour/inspector Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $660/hour/inspector Item 9ACA

Blood plasma and technical master files

The evaluation fee for blood plasma master files and blood technical master fees depends on the number of pages. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Pages Fee Item in Schedule 9 Part 2
1-10 $1,290 Item 9AD(a)
11-50 $11,000 Item 9AD(b)
51-100 $24,600 Item 9AD(c)
101-1000 $33,100 Item 9AD(d)
1001-3000 $51,600 Item 9AD(e)
3001-4000 $68,800 Item 9AD(f)
>4000 $83,900 Item 9AD(g)

Miscellaneous fees

This fee in Schedule 9, Therapeutic Goods Regulations 1990 applies, to human blood, blood components and HPCs and human tissues not regulated as biologicals.

Application type Fee Item in Schedule 9 Part 2
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $460 Item 1A

Medical devices

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Medical devices are included (not listed or registered) in the ARTG.

Sponsoring medical devices

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Class of medical device Charge Therapeutic Goods (Charges) Regulations 1990
AIMD $1,140 Regulation 3(1B)(d)
Class III $1,140 Regulation 3(1B)(d)
Class IIb $880 Regulation 3(1B)(c)
Class IIa $880 Regulation 3(1B)(c)
Class I - sterile $610 Regulation 3(1B)(b)
Class I - measuring function $610 Regulation3(1B)(b)
Class I - other $80 Regulation3(1B)(a)

Application fees

These fees are to apply to include a medical device in the ARTG. Application audit assessment fees are often payable as well. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class of medical device Application fee Item in Schedule 5 Part 1
AIMD $1,290 Item 1.5(a)
Class III $1,290 Item 1.5(b)
Class IIb $1,000 Item 1.5(c)
Class IIa $1,000 Item 1.5(d)
Class I - sterile $1,000 Item 1.5(e)
Class I - measuring function $1,000 Item 1.5(e)
Class I - other n/a n/a

n/a: not applicable

Application audit assessment fees

An application audit assessment fee is payable in addition to the application fee for the inclusion of some medical devices in the ARTG. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Type of application audit Assessment fee Item in Schedule 5 Part 1
Level 1 - verification of sponsor's application and evidence of conformity $3,760 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $6,900 Item 1.14

Variation fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990. For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Application type Application fee Item in Schedule 9 Part 2
Variation to an ARTG inclusion entry $440 Item 2A(g)

Miscellaneous

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.
Type of application Fee Item in Schedule 5 Part 1
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 $440 Item 1.15
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG $6,900 Item 1.6

Manufacturing medical devices

Information about conformity assessment is in Part 1, Australian regulatory guidelines for medical devices. Fees are in Therapeutic Goods (Medical Devices) Regulations 2002.

Application for conformity assessment

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $980 Item 1.1

Initial assessment of conformity assessment

In addition to the application fee, one or more of the following fees will apply to your kind of medical device. Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.
Type of conformity Fee for initial assessment Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,100 Item 1.9(a)
Design examination: Schedule 3, Clause 1.6 $57,200 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $39,900 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests): Schedule 3, Part 3 $27,900 Item 1.9(d)
Production quality management system inspection: Schedule 3, Part 4 $25,500 Item 1.9(e)
Product quality management system inspection: Schedule 3, Part 5 $21,800 Item 1.9(f)

Changes to conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002.

Type of conformity Fee for change Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $17,500 Item 1.10(a)
Design examination: Schedule 3, Clause 1.6 $34,500 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $24,000 Item 1.10(c)
Production quality management system inspection: Schedule 3, Part 4 $15,100 Item 1.10(d)
Product quality management system inspection: Schedule 3, Part 5 $13,200 Item 1.10(e)

Surveillance inspections - conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of surveillance inspection Fee Item in Schedule 5 Part 1
Full quality management system surveillance inspection: Schedule 3, Part 1 $8,460 Item 1.2(a)
Production quality management system surveillance inspection: Schedule 3, Part 4 $8,460 Item 1.2(a)
Product quality management system surveillance inspection: Schedule 3, Part 5 $8,460 Item 1.2(a)

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of certificate being reviewed Fee Item in Schedule 5 Part 1
Design examination re-assessment: Schedule 3, Clause 1.6 $51,700 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $39,900 Item 1.3(b)

Additional inspection fees

For medical devices that incorporate a medicine, application and evaluation fees apply for the medicine component as well as fees related to assessing the device.

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002.

Inspection costs Fee Paragraph in Schedule 5 Part 2
Supplementary additional assessment conducted outside Australia in addition to assessment mentioned in item 1.2, 1.3, 1.9 or 1.10, Schedule 5 $410/assessor hour Paragraph 2.1(b)
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia costs and reasonable expenses Paragraph 2.1(a)
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 Paragraph 2.2

Issuing quality systems certificates

Certificate Fee
Quality systems certificate $170
Certified copy of quality systems certificate $60

IVD medical devices

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The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Class of IVD Charge Regulation
All classes of IVD excluding Class 4 in-house IVDs $660 3(1B)(e)
Class 4 in-house IVDs n/a 3(1B)(f)

n/a: not applicable

Notification fee

Laboratories that manufacture Class 1, Class 2 or Class 3 in-house IVDs are required to provide a notification to the TGA. These in-house IVDs are not required to be included in the ARTG.

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class of IVD Notification fee Item in Schedule 5 Part 1
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,000 Item 1.17

Application fees

These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are often payable as well. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990.

For guidance on variations go to Varying entries in the ARTG - medical devices and IVDs.

Application Application fee Item in Schedule 5 Part 1
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs $1,000 Item 1.5(f), Schedule 5 Part 1 Therapeutic Goods (Medical Devices) Regulations 2002
Variation to an ARTG inclusion entry $440 Item 2A(g) Schedule 9 Part 2 Therapeutic Goods Regulations 1990

Application audit assessment fees

An application audit assessment fee is payable in addition to the application fee for the inclusion of some medical devices in the ARTG.

Go to IVD guidance documents: Application audit (technical file review) and Regulatory requirements for in-house IVDs for more details.

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Type of IVD Assessment fee Item in Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $6,720 Item 1.14A
Class 4 in-house IVDs $62,200 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,100 Item 1.14C

Manufacturing IVDs

Application for conformity assessment

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $980 Item 1.1

Initial assessment of conformity assessment

In addition to the application fee, one or more of the following fees will apply to your kind of medical device.

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of conformity Fee Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,200 Item 1.9A(a)
Design examination: Schedule 3, Clause 1.6 $62,200 Item 1.9A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,100 Item 1.9A(c)
Type examination: Schedule 3, Part 2 $40,300 Item 1.9A(e)
Production quality management system inspection: Schedule 3, Part 4 $25,700 Item 1.9A(f)

Review of certificate of conformity assessment

Conformity assessment procedures are legislated in Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002 and the fees are in Schedule 5.

Type of certificate being reviewed Fee Item in Schedule 5 Part 1
Full quality management system inspection: Schedule 3, Part 1 $29,200 Item 1.3A(a)
Design examination: Schedule 3, Clause 1.6 $62,200 Item 1.3A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,100 Item 1.3A(c)
Type examination: Schedule 3, Part 2 $40,300 Item 1.3A(e)
Production quality management system inspection: Schedule 3, Part 4 $25,700 Item 1.3A(f)

Other IVD conformity assessment fees

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002.

Other assessment for IVD conformity assessment Fee Item or paragraph in Schedule 5
Supplementary additional assessment in addition to assessment mentioned in item 1.2, 1.3A, 1.9A or 1.10A [item 2.1(b), Schedule 5] $410/assessor hour Item 1.12
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia costs and reasonable expenses Paragraph 2.1(a)
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $8,510 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD $17,500 Item 1.10A
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,720 Item 1.14A

Other listed and registered therapeutic goods (OTGs)

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Other listed and registered therapeutic goods (OTGs) include:

OTGs are the goods that meet the definition of a therapeutic good, but do not meet either a definition of a medical device or a medicine or a biological.

In this section, we have only included fees and charges that directly apply to these goods.

For a complete list, go to the relevant legislation.

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Type of OTG Charge Regulation
Listed OTG: tampons and disinfectants $820

Regulation 3(1)(c)(iii)

Regulation 3(1A)(c)(iii)

Registered OTG - disinfectants $1,610

Regulation 3(1)(a)(iii)

Regulation 3(1A)(a)(iii)

Listed OTG fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Listed OTG fees Fee Item in Schedule 9 Part 2
Application fee $440 Item 3(a)
Variation fee $440 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $17,900 Item 9C

Registered OTG fees

These fees are in Therapeutic Goods Regulations 1990.

Registered OTG fee type Fee

Item in Schedule 9 Part 2

OR, the regulation

Low level registered device - application fee $1,430 Item 2(b),(g)
Low level registered device - disinfectant initial evaluation fee $17,900 Item 5B
Low level registered device - variation processing fee $440 Item 2A(d)
Low level registered device - disinfectant variation initial evaluation fee $3,590 Item 6B
Clinical trial notification (CTN) $350 Item 14A
High level registered device - application fee $4,270 Item 2(c)
High level registered device - variation processing fee $440 Item 2A(e)
High level device - variation manufacturing and/or quality control - initial evaluation $8,910 Item 7(b)
High level registered device - variation manufacturing and/or quality control - concurrent evaluation $1,960 Regulation 45(11)(a-e)

Miscellaneous fees

This fee is in Schedule 9, Therapeutic Goods Regulations 1990.

Application type Fee Item in Schedule 9 Part 2
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $460 Item 1A

Clinical trials

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The Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes provide two avenues for conducting clinical trials involving the use of unapproved therapeutic goods.

Unapproved medicines

These fees for clinical trials of unapproved medicines are in Part 2, Schedule 9, Therapeutic Goods Regulations 1990.

Unapproved medicines Fee Item in Schedule 9 Part 2
Clinical trial notification (CTN) $350 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $350 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,690 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,100 Item 1(b)

Unapproved biologicals

These fees for clinical trials of unapproved biologicals are in Part 2, Schedule 9A, Therapeutic Goods Regulations 1990.

Biologicals Fee Item in Schedule 9A Part 2
Clinical trial notification (CTN) $350 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $350 Item 17(b)
Clinical trial exemption (CTX) $25,600 Item 16

Unapproved medical devices (including IVDs)

These fees for clinical trials of unapproved medical devices and IVDs are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Unapproved medical devices (including IVD) Fee Item in Schedule 5 Part 1
Clinical trial notification (CTN) $350 Item 1.8
Clinical trial exemption (CTX) $17,900 Item 1.7

Unapproved other therapeutic goods

These fees for clinical trials of unapproved other therapeutic goods are in Part 2, Schedule 9, Therapeutic Goods Regulations 1990.

Unapproved other therapeutic goods Fee Item in Schedule 9 Part 2
Clinical trial notification (CTN) $350 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $350 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,690 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $17,900 Item 1(c)

Advertising

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The fees for an application for pre-approval of an advertisement for therapeutic goods under Regulation 5F of the Therapeutic Goods Regulations 1990 are set out in items 17 and 17A in Schedule 9 of the regulations. Each approved advertisement is given an approval number on the date of approval. The approval number expires two years from the date it is given under regulation 5J.

The fee includes up to one hour of processing time for each application. Any additional time beyond one hour is charged at the rate of $210/hour or part of an hour for those advertisements marked (*) in the tables below.

Specified media excluding broadcast media

'Specified media' is defined in section 42B of the Therapeutic Goods Act 1989. Fees are in in Schedule 9, Therapeutic Goods Regulations 1990.

Type of advertisement in specified media Fee Item in Schedule 9 Part 2
Advertisement* intended for publication in the classified advertisements column of a newspaper or other printed publication $120 Item 17 (a)(iv)
Advertisement* of 100 words or less $240 Item 17 (a)(i)
Advertisement* of more than 100 words but of 300 words or less $290 Item 17 (a)(ii)
Advertisement* of more than 300 words (including an advertorial) $460 Item 17 (a)(iii)
Moving cinema advertisement* of 150 seconds or less in length, with up to 3 variations of the advertising concept, for the same product. $1,170 Item 17A (a)(i)
Still cinema advertisement* (including outdoor media) of 100 words or less $240 Item 17A(a)(vi)(A)
Still cinema advertisement* (including outdoor media) of more than100 words but of 300 words or less $290 Item 17A(a)(vi)(B)
Still cinema advertisement* (including outdoor media) of more than 300 words. $460 Item 17A(a)(vi)(C)
Cinema advertisement* (including outdoor media) for a minor change to an approved advertisement sought more than 3 months after the date the approval number was given. (There is no charge when sought 3 months or less.) 50% of applicable fee, including any fee for additional hours Item 17A(c)
Advertisement (other than cinema advertisement) that is a minor change to an approved advertisement sought more than 3 months after the date the approval number was given. (There is no charge when sought 3 months or less) $120 Item 17(c)
Advertisement* for re-approval of an identical advertisement whose approval number has expired 50% of applicable fee, including any fee for additional hours Items 17(d) and 17A(d)(cinema)
Advertisement* for approval of a variation to an advertisement whose approval number has not expired. 50% of applicable fee, including any fee for additional hours Items 17(e) and 17A(e)(cinema)
Each additional hour or part thereof after the first processing hour, in addition to the specified fee for the advertisements marked with an asterisk (*) in this table. $210 Items 17(b) and 17A(b)(cinema)

* Any additional time beyond one hour is charged at the rate of $210/hour

Broadcast media

'Broadcast media' is defined in section 42B of the Therapeutic Goods Act 1989.

Certain broadcast media, for example the internet and certain mobile communications, are excluded from this definition for pre-approval of advertisements for therapeutic goods, by Regulation 5BA, Therapeutic Goods Regulations 1990. Fees are in Schedule 9 to the Therapeutic Goods Regulations 1990.

The term "commercial" and "advertorial" can be used in place of "advertisement" in relation to broadcast media.

Type of advertisement in broadcast media Fee Item in Schedule 9 Part 2
Television advertisement* of 150 seconds or less in length with up to 3 variations of the advertising concept for the same product $1,170 Item 17A (a)(i)
Television advertisement* for a retail outlet that is intended to be broadcast on 1 regional station only in that station's regional area $620 Item 17A (a)(ii)
Television advertorial* greater than 150 seconds in length

$880 for first minute of script

$250 for each additional minute or part minute

Item 17A (a)(iii) (A)(B)
Radio Advertisement* including up to 6 variations of the advertising concept for the same product $430 Item 17A (a)(iv)
Radio Advertisement* that is intended to be broadcast in a regional area only including up to six variations of the advertising concept for the same product $300 Item 17A (a)(v)
Advertisement* that is a minor change to an approved advertisement sought more than 3 months after the date of approval. (There is no charge when sought 3 months or less.) 50% of applicable fee, including any fee for additional hours Item 17A (c)
Advertisement* requiring re-approval of an identical advertisement whose approval number has expired. 50% of applicable fee, including any fee for additional hours Item 17A (d)
Advertisement* requiring approval of a variation to an advertisement whose approval number has not expired 50% of applicable fee, including any fee for additional hours Item 17A (e)
Each additional hour or part thereof after the first processing hour, in addition to the specified fee for the advertisements marked with an asterisk (*) in this table. $210 Item 17A (b)

* Any additional time beyond one hour is charged at the rate of $210/hour

General fees

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Transfer of sponsorship

There are no fees for the transfer of sponsorship. However, there are fees associated with some changes to therapeutic goods that need to occur as a result of sponsor transfer, such as changes to registered medicine labels or variation of ARTG entry following acceptance of a new Manufacturer Evidence.

Fees related to annual charges exemption (ACE) scheme

To maintain an annual charge exemption, sponsors are able to self-declare that their product had no turnover. Self-declarations must be submitted to the TGA between 1 July and 22 July each year or it will be assumed that the product generated greater than $0 turnover. Late declarations made before 15 September under regulation 43AAE(2) of the Therapeutic Goods Regulations 1990 attract a late declaration fee.

Number of ARTG entries Late declaration fee Item in schedule of Therapeutic Goods Regulations 1990
If the declaration relates to not more than 5 entries in the ARTG $410

Schedule 9 Part 2 Item 3AB (a)

Schedule 9A Part 2 Item 3A (a)

If the declaration relates to 6 or more entries in the ARTG

$410 for first 5 entries +

$50 for each additional entry

Schedule 9 Part 2 Item 3AB (b)

Schedule 9A Part 2 Item 3A (b)

Fees related to a request to revoke an ARTG entry cancellation

There are fees for the requests for revocation of:

  • the voluntary cancellation of an ARTG entry by the sponsor
  • the cancellation of an ARTG entry that was cancelled due to non-payment of the annual charge
Number of ARTG entries Fee for revocation of cancellation Legislation
If the request relates to one entry in the ARTG $150

Schedule 5 Part 1 Item 1.6A(a) and 1.6B(a) Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 9 Part 2 Item 6BA(a) and 6(BB)(a) Therapeutic Goods Regulations 1990

Schedule 9A Part 2 Item 16A(a) and 16B(a) Therapeutic Goods Regulations 1990

If the request relates to more than one entry in the ARTG

$150 for first entry +

$50 for each additional entry

Schedule 5 Part 1 Item 1.6A(b) and 1.6B(b) Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 9 Part 2 Item 6BA(b) and 6BB(b) Therapeutic Goods Regulations 1990

Schedule 9A Part 2 Item 16A(b) and 16B(b) Therapeutic Goods Regulations 1990

Version history

Version 2.2, December 2017

4 December 2017
Version Description of change Author Effective date
V1.0 Original publication for the financial year July 2017 to June 2018 Regulatory Services and Improvement Branch 01/07/2017
V2.0

Update with additional fees as a result of the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017

Minor editorial changes to advertising section

Regulatory Services and Improvement Branch 01/07/2017
V2.1 Minor clarifications Regulatory Services and Improvement Branch September 2017
V2.2

Update with additional fee for notification request for a prescription medicine

Minor editorial changes

Regulatory Services and Improvement Branch December 2017