Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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.

Go to:

This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.

For a complete list of all fees and charges and the exact legislative wording, please refer directly to the legislation.

Prescription medicines

Version 1.1, July 2019

25 July 2019

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 for prescription medicines

Table 1: Annual charges for prescription medicines
Type of prescription medicine Charge Regulation
Biological medicine $7,270

Item 7(1)(b)(i)(ii)(iii)

Item 7(2)(b)(i)(ii)(iii)

Non-biological medicine (chemical entity) - subsection 3-10 of regulation 8 $4,140 8(2)(a)
Non-biological medicine (chemical entity) - otherwise $3,360 8(2)(b)
Provisionally registered biological medicine $16,400 9(1)(a)
Provisionally registered non-biological medicine $13,400 9(1)(b)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

More about chemical entities annual charges

Higher annual charges

Regulation 8 of the Therapeutic Goods (Charges) Regulations 2018 states when the higher annual charge applies for prescription medicine chemical entities.

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

  • whatever the duration of registration, for medicines containing at least one specified active ingredient:
    • 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.

Application and evaluation fees for prescription medicines

Standard prescription medicine processes

These applications have both an application fee and an evaluation fee.

Table 2: Standard prescription medicine processes
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
New chemical entity* $48,800 $195,700 Item 2(ba) and Item 4(a)
Extension of indications* $29,100 $116,100 Item 2(bd) and Item 4(b)
Major variations*^ $19,000 $75,700 Item 2(bi) and Item 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)^ $1,120 $4,450 Item 2(bj) and Item 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*^ $1,120 $4,450 Item 2AC and Item 2C
Additional trade name^ $3,080 $12,300 Item 2(bh) and Item 4(d)
New generic product* $18,800 $74,700 Item 2(bg) and Item 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 $1,120 $4,450 Item 2(bk) and Item 4(bc)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989
n/a: not applicable;
* the fees are the same for the standard process and the comparable overseas regulator report-based process
^the fees are the same for registered and provisionally registered medicines

Priority review pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 3: Priority review pathway for prescription medicines
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
Priority determination of a prescription medicine $12,800 n/a Item 1B
New prescription medicine in the priority pathway $51,700 $207,000 Items 2(bca) and 4(ab)
New indications medicine in the priority pathway $30,800 $123,100 Items 2(bfa) and 4(bd)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Provisional approval pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 4: Provisional approval pathway for prescription medicines
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
Provisional determination of a prescription medicine $12,800 n/a Item 1AA
Extension of provisional determination $ 4,610 n/a Item 1AB
Provisional registration of a new prescription medicine $48,900 $255,300 Items 1AC(a) and 1AD(a)
Provisional registration of a new indications medicine $29,200 $168,400 Items 1AC(b) and 1AD(b)
Extension of provisional registration $17,600 n/a Item 1AG
Transition from provisional registration to full registration* $29,100 $122,800 Items 1AE and 1AF

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable;
*: Fees for an application under Section 23 for registration of a medicine that is included in the part of part of the ARTG for goods known as provisionally registered goods to be included in the part of the ARTG for goods known as registered goods

Requests with single fee

These requests have a single fee, instead of an application fee and an evaluation fee.

Table 5: Requests with single fee
Prescription medicine request Fee 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. $5,570 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,710 Item 2A(a)
Correction to an ARTG entry $1,710 Item 2A(a)
Notification request $810 Item 2CB
Self-assessable request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with evaluation of data $5,570 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,260 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. $480 Item 1A

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

Table 6: Medicines as components of devices
Application type Application fee Evaluation fee Schedule 9, Part 2
New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $16,200 $65,300

Item 2(bb)

Item 4(aa)(i)

Item 4(aa)(ii)

New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $32,600 $130,200

Item 2(bc)

Item 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 $9,680

$38,700

Item 2(be)(i)

Item 4(bb)(i)(a)

Item 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 $19,500 $77,400

Item 2(bf)(i)

Item 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 $6,320 $25,100

Item 2(be)(ii)

Item 4(bb)(i)(b),

Item 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 $12,700 $50,600

Item 2(bf)(ii)

Item 4(bb)(iii)(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Non-prescription medicines

Version 1.1, July 2019

25 July 2019

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.

Listing applications

The following fees and charges apply to medicines listed under section 26A of the Act.

Table 7: Listing applications
Listed medicine fee or charge Amount Legislation
Annual charge $1,140

Therapeutic Goods (Charges) Regulations 2018

Item 7(1)(c)(i) and Item 7(2)(c)(i)

Application fee $840

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 3(b)

Processing fee (variation to an existing listing) $430

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 $480

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 1A

These fees are in the Therapeutic Goods (Charges) Regulations 2018 and the Therapeutic Goods Regulations 1990
"The Act" refers to the Therapeutic Goods Act 1989.

Permitted indication list

Applications for a new permitted indication have an application fee.

Table 8: Permitted indication list
Listed medicine fee or charge Amount Schedule 9, Part 2
Application fee for a new indication to be added to the permitted indication list $1,060 Item 7C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Permitted ingredients for listed complementary medicines

The ingredient application pathway is available for applications related to ingredients (new or variations) in:

  • listed complementary medicines (under section 26A of the Act)
  • assessed listed medicines (under section 26AE of the Act)

The ingredient application pathway is not available for ingredients in:

  • listed medicines that are not complementary medicines, such as sunscreens
  • registered medicines

An application to vary the permitted ingredients list has both an application fee and an evaluation fee.

Table 9: Permitted ingredients for listed complementary medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
IN1 $1,090 $14,600 Item 28 and Item 29
IN2 $1,090 $14,600 Item 30 and Item 31
IN3 $2,880 $23,800 Item 32 and Item 33
IN4 $2,880 $23,800 Item 34 and Item 35

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Assessed listed complementary medicines

Annual charge for assessed listed medicines

Assessed listed complementary medicines have an annual charge.

Table 10: Annual charge for assessed listed medicines
Annual charge Amount Legislation
Annual charge $1,140 Part 2 Item 7(1)(c)(i) and Part 2 Item 7(2)(c)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Assessed listed applications

Applications for assessed listed complementary medicines (under section 26AE of the Act) have both an application fee and an evaluation fee.

Table 11: Assessed listed applications
Application Category Application fee Evaluation fee Schedule 9, Part 4
L(A)1 $450 $1,700 Item 22 and Item 23
L(A)2 $1,830 $14,000 Item 24 and Item 25
L(A)3 $1,830 $14,000 Item 26 and Item 27

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to assessed listed medicines

Table 12: Section 23 applications
Application type Application fee Evaluation fee Schedule 9 Part 4
L(A)CN (section 23) application $790 n/a Item 1F
L(A)C1 (section 23) application $920 $1,070 Item 1D and 1G
L(A)C2 (section 23) application $920 $7,770 Item 1E and 1H

These fees are in the Therapeutic Goods Regulations 1990

Table 13: Section 9D applications
Application type Upfront fee Refund if no evaluation Schedule 9 Part 4
L(A)CN (section 9D) notification request $790 n/a Item 1C
L(A)C1 (section 9D) application $1,990 $1,070 Item 1A
L(A)C2 (section 9D) application $8,690 $7,770 Item 1B

These fees are in the Therapeutic Goods Regulations 1990

New substances

The new substances application pathway is available for applications for:

  • a new substance in a listed medicine that is not a complementary medicine, such as a sunscreen
  • a new substance for registered non-prescription medicines
  • multiple new excipients in listed or registered non-prescription medicines for dermal use

The new substance application pathway is not available for applications for ingredients in:

  • listed complementary medicines
  • assessed listed complementary medicines

There are evaluation fees, but no application fees for new substance applications.

Table 14: New substances
Pages of nonclinical and clinical data Evaluation fee Schedule 9, Part 2
0-50 $10,700 Item 7A(a), Item 7A(b)(i), Item 7B(a) and Item7B(b)(i)
51-250 $13,800 Item 7A(b)(ii) and Item 7B(b)(ii)
251-500 $18,800 Item 7A(b)(iii) and Item 7B(b)(iii)
501-1000 $24,900 Item 7A(b)(iv) and Item 7B(b)(iv)
1001-2000 $37,400 Item 7A(b)(v) and Item 7B(b)(v)
2001-3000 $49,800 Item 7A(b)(vi) and Item 7B(b)(vi)
>3000 $74,700 Item 7A(b)(vii) and Item 7B(b)(vii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Registered complementary medicines

Annual charges for registered complementary medicines

Registered complementary medicines have an annual charge.

These charges are in the Therapeutic Goods (Charges) Regulations 2018.

Table 15: Annual charges for registered complementary medicines
Charge Amount Regulation
Annual charge $1,490 Item 7(1)(a)(i) and Item7(2)(a)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Application and evaluation fees for registered complementary medicines

Applications for registered complementary medicines have both an application fee and an evaluation fee.

Table 16: Application and evaluation fees for registered complementary medicines
Application Category Application fee Evaluation fee Item in Schedule 9, Part 4
RCM1 $550 $3,180 Item 12 and Item 13
RCM2 $1,990 $21,300 Item 14 and Item 15
RCM3 $1,990 $21,300 Items 16 and Item 17
RCM4 $2,630 $28,900 Item 18 and Item 19
RCM5 $2,880 $36,900 Item 20 and Item 21

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Section 23 application to change registered complementary medicines

For applications to change registered complementary medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

Table 17: Section 23 application to change registered complementary medicines
RCM change application category Application fee Evaluation fee Schedule 9, Part 4
RCMC1 $1,410 n/a Item 5
RCMC2 $760 $4,120 Item 6 and Item 7
RCMC3 $810 $6,440 Item 8 and Item 9
RCMC4 $830 $9,520 Item 10 and Item 11

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D application to change registered complementary medicines

For applications to change registered complementary medicines made under section 9D of the Therapeutic Goods Act 1989, there is an application fee and a refund if no evaluation occurs for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

Table 18: Section 9D application to change registered complementary medicines
RCM change application category Upfront fee Refund if no evaluation Item and Part in Schedule 9
Notification requests $810 n/a Part 2, items 2CC and Part 2 Item 2CB
RCMC1 $1,440 n/a Part 4, Item 1
RCMC2 $4,880 $4,120

Part 4 Item 2 and Paragraph 43ACA(2)(a)*

RCMC3 $7,250 $6,440

Part 4 Item 3 and Paragraph 43ACA(2)(b)*

RCMC4 $10,300 $9,520

Part 4 Item 4, and Paragraph 43ACA(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990

Other fees for registered complementary medicines

Table 19: Other fees for registered complementary medicines
Type of fee or charge Amount 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 $480 Item 1A

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
The "Act" refers to the Therapeutic Goods Act 1989.

Registered OTC medicines

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

Annual charges for registered OTC medicines

Registered OTC medicines have an annual charge.

Table 20: Annual charges for registered OTC medicines
Medicine type Charge Regulation
Registered OTC medicine $1,490 Item 7(1)(a)(i) and Item 7(2)(a)(i)

These charges are in Part 2 of the Therapeutic Goods (Charges) Regulations 2018

New registered OTC medicine applications

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

Table 21: New registered OTC medicine applications
Application type Application fee Evaluation fee Schedule 9 Part 3
N1 application $1,650 $4,080 Item 1(a) and Item 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $830 $4,080 Item 3(d) and Item 2(a)
N2 application $1,650 $5,800 Item 1(b) and Item 2(b)
N2 concurrent application per additional application (as described in item 3 of Part 3 Schedule 9 of the Regulations) $830 $5,800 Item 3(e) and Item 2(b)
N3 application $2,650 $8,930 Item 1(c) and Item 2(c)
N3 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,330 $4,520 Item 3(f) and Item 4(d)
N4 application $3,870 $14,800 Item 1(d)and Item 2(d)
N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,330 $4,520 Item 3(g)and Item 4(e)
N5 application $5,740 $21,900 Item 1(e) and Item 2(e)
N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,330 $4,520 Item 3(h) and Item 4(f)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Section 23 application to change registered OTC medicines

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.

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

Table 22: Section 23 application to change registered OTC medicines
Application type Application fee Evaluation fee Schedule 9 Part 3
C1 (section 23) application $1,650 n/a Item 1(f)
C2 (section 23) application $1,650 $4,080 Item 1(g) and Item 2(f)
C3 (section 23) application $1,650 $6,850 Item 1(h) and Item 2(g)
C4 (section 23) application $2,650 $8,930 Item 1(i) and Item 2(h)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D application to change registered OTC medicines

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.

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

Table 23: Section 9D application to change registered OTC medicines
Application type Upfront fee Refund if no evaluation Regulation
CN (section 9D) notification request $810 n/a Part 2 Item 2CB and Part 2 Item 2CD
C1 (section 9D) application $1,650 n/a Part 3 Item 5(a)
C2 (section 9D) application $5,740 $4,080

Part 3 Item 5(b) and Paragraph 43AC(2)(a)*

C3 (section 9D) application $8,500 $6,850

Part 3 Item 5(c) and Paragraph 43AC(2)(b)*

C4 (section 9D) application $11,600 $8,930

Part 3 Item 5(d) and Paragraph 43AC(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990
n/a: not applicable

for registered OTC medicines

Table 24: Other fees for registered OTC medicines
Registered OTC medicine request Fee 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 $1,620 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 $8,310 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. $480 Item 1A

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
The "Act" refers to the Therapeutic Goods Act 1989.

Manufacturing medicines and OTGs

Version 1.1, July 2019

25 July 2019

The section applies to the manufacture of:

Annual charges for manufacturing licences

Manufacturing licences have an annual charge.

Table 25: Annual charges for manufacturing licences
Annual charges for manufacturing licences Charge Regulations
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,680 Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e)
Manufacturing licence charge for therapeutic device (other therapeutic good) $6,510 Item 7(5)(d)

These charges are in the Therapeutic Goods (Charges) Regulations 2018
Only highest applicable charge is payable

Manufacturing inspections

Australian manufacturing licences

Applications for Australian manufacturing licences have application, variation and inspection fees.

Table 26: Australian manufacturing licences
Fees related to Australian manufacturing licences Fee Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $790 Item 8(a)
Application for variation of a manufacturing licence $790 Item 8A
Australian manufacturing sites - inspection fee $990/hour/inspector Item 9(a)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Overseas manufacturing site inspections

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

Table 27: Overseas manufacturing site inspections
Overseas manufacturing site inspections Fee Schedule 9 Part 2
Overseas manufacturing sites - inspection fee $1,390/hour/inspector Item 9(b)
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia costs and reasonable expenses

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

GMP clearance fees

There is no application fee for GMP clearance.

GMP clearance of overseas manufacturers Fee Schedule 9 Part 2
GMP clearance application processing fee (per manufacturer, per site, per sponsor) $650 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $700 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,480 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,180 Item 6AC

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Issuing manufacturing certificates

There are fees for issuing manufacturing certificates.

Table 29: Issuing manufacturing certificates
Certificate Fee
Certificate of GMP compliance $180
Mutual Recognition Agreement certificate $340

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

Export of therapeutic goods

Version 1.1, July 2019

25 July 2019

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.

Table 30: Medicine export certificates
Certificate type Fee Item in Schedule 9 Part 2
Certificate of pharmaceutical product $180 Item 10
Certificate of listed product $180 Item 10
Certificate of exempt product $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Listed export-only medicines

There is an application fee and a processing fee for listed export-only medicines.

Table 31: Listed export-only medicines
Export only applications Fee Item in Schedule 9 Part 2
Application fee $840 Item 3(b)
Processing fee (variation to an existing listing) $430 Item 2A(c)

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

Device export certificates

You can apply for an export certificate for a medical device (including IVD devices) or OTG.

Table 32: Device export certificates
Certificate type Fee Schedule 9 Part 2
Certificate of free sale $180 Item 10
Export certificate $180 Item 10

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Export-only devices

These fees apply to include a medical device, including IVD device, in the ARTG that is for export only.

Table 33: Export-only devices
Export only applications Fee Schedule 5 Part 1
Application for inclusion into the ARTG of export only devices $90 Item 1.5(f)
Application for inclusion into the ARTG of export only IVD devices $90 Item 1.5(i)

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Biologicals

Version 1.1, July 2019

25 July 2019

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.

Annual charges for manufacturing biologicals

There is no annual charge for a manufacturer who only manufactures biologicals [regulation 7(5)(j) Therapeutic Goods (Charges) Regulations 2018].

Manufacturing biologicals fees

There is an application fee and various inspection fees for manufacturing biologicals.

Table 34: Manufacturing biologicals fees
Manufacturing biologicals Fee Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,110 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,900 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,600 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $680/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 fees are in Schedule 9A, Therapeutic Goods Regulations 1990.

There are annual charges for including a biological in the ARTG.

Table 35: Annual charges for sponsoring biological
ARTG inclusion of biologicals Amount Regulation
Class 1 biological annual charge for ARTG inclusion $680 Regulation 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,760 Regulation 7(3)(b)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Table 36: Fees for sponsoring biologicals
Sponsoring biologicals Fee Schedule 9A Part 2
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $23,900 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,110 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,110 Item 2
Variation application fee - all classes $1,110 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $73,700 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,760 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $147,400 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $239,500 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $34,900 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,800 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,760 Item 8A

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

Blood, blood components and HPCs

Version 1.1, July 2019

25 July 2019

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

Table 37: Manufacturing annual charges
Therapeutic good being manufactured Charge Regulation
Blood and blood components (not HPCs) - primary manufacturing site $163,600 Item 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $8,050 Item 7(5)(f)(ii)
HPCs manufacturing site $7,040 Item 7(5)(g)

These charges are in the Therapeutic Goods (Charges) Regulations 2018
Only highest applicable charge is payable

Manufacturing fees

Table 38: Manufacturing fees
Manufacturing fees Fee Schedule 9 Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,040 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $920/inspector/hour Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $680/inspector/hour Item 9AC
HPCs - Australian manufacturing site inspection fee $680/inspector/hour Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $680/inspector/hour Item 9ACA

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

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.

Table 39: Blood plasma and technical master files
Pages Fee Schedule 9 Part 2
1-10 $1,340 Item 9AD(a)
11-50 $11,400 Item 9AD(b)
51-100 $25,600 Item 9AD(c)
101-1000 $34,400 Item 9AD(d)
1001-3000 $53,700 Item 9AD(e)
3001-4000 $71,500 Item 9AD(f)
>4000 $87,300 Item 9AD(g)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Miscellaneous fees

This fee applies to human blood, blood components and HPCs and human tissues not regulated as biologicals.

Application type Fee 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. $480 Item 1A

This fee in Schedule 9, Therapeutic Goods Regulations 1990

Medical devices

Version 1.1, July 2019

25 July 2019

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

Sponsoring medical devices

Table 41: Annual charges
Class of medical device Charge Regulation
AIMD $1,180 Item 7(4) (d)
Class III $1,180 Item 7(4) (d)
Class IIb $920 Item 7(4)(c)
Class IIa $920 Item 7(4)(c)
Class I - sterile $630 Item 7(4)(b)
Class I - measuring function $630 Item 7(4)(b)
Class I - other $90 Item 7(4)(a)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

These fees are to apply to include a medical device in the ARTG. Application audit assessment fees are often payable as well. Application fees for export only devices are not included in this section.

Table 42: Application fees
Class of medical device Application fee Schedule 5 Part 1
AIMD $1,340 Item 1.5(a)
Class III $1,340 Item 1.5(b)
Class IIb $1,040 Item 1.5(c)
Class IIa $1,040 Item 1.5(d)
Class I - sterile $1,040 Item 1.5(e)
Class I - measuring function $1,040 Item 1.5(e)
Class I - other (excluding export only devices) $540 Item 1.5(g)

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002
Note: Refer to export only device application fees

This fee is for applicants seeking Priority review designation for an application to include a medical device in the ARTG.

For guidance on how to seek Priority Review go to Priority review designations medical devices (including IVDs).

Table 43: Application for medical devices (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device $10,000 Item 1.5A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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

Table 44: Application audit assessment fees
Type of application audit Assessment fee Schedule 5 Part 1
Level 1 - verification of sponsor's application and evidence of conformity $3,910 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $7,170 Item 1.14

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

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

Table 45: Variation fees
Application type Application fee Schedule 9 Part 2
Variation to an ARTG inclusion entry $460 Item 2A(g)

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

Table 46: Miscellaneous
Type of application Fee 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 $460 Item 1.15
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG (as described in item 1.6) $7,170 Item 1.14

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

Conformity assessment bodies designation determination

These applications have both an application fee and an assessment fee.

Table 47: Conformity assessment bodies designation determination
Application type Application fee Assessment fee Regulation
Full designation conformity assessment body determination $4,570 $74,600 Item 1.4A and Item 1.4D
Partial designation conformity assessment body determination (full QMS) $2,510 $53,600 Item 1.4B and Item 1.4E
Partial designation conformity assessment body determination (partial QMS or partial devices) $2,510 $53,600 Item 1.4C and Item 1.4F

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

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

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

Table 48: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,020 Item 1.1

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

Application for conformity assessment (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application for TGA conformity assessment of a medical device.

Table 49: Application for conformity assessment (priority applicant) determination
Application type Application fee Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device $10,000 Item 1.1A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

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.

Table 50: Initial assessment of conformity assessment
Type of conformity Fee for initial assessment Schedule 5 Part 1
Full quality management system inspection (described in Schedule 3, Part 1) $30,300 Item 1.9(a)
Design examination (described in Schedule 3, Clause 1.6) $59,500 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $41,500 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests) (described in Schedule 3, Part 3) $29,000 Item 1.9(d)
Production quality management system inspection (described in Schedule 3, Part 4) $26,500 Item 1.9(e)
Product quality management system inspection (described in Schedule 3, Part 5) $22,700 Item 1.9(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Changes to conformity assessment

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

Table 51: Changes to conformity assessment
Type of conformity Fee for change Schedule 5 Part 1
Full quality management system inspection (described in Schedule 3, Part 1) $18,200 Item 1.10(a)
Design examination (described in Schedule 3, Clause 1.6) $35,900 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $25,000 Item 1.10(c)
Production quality management system inspection (described in Schedule 3, Part 4) $15,700 Item 1.10(d)
Product quality management system inspection (described in Schedule 3, Part 5) $13,800 Item 1.10(e)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Surveillance inspections - conformity assessment

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

Table 52: Surveillance inspections - conformity assessment
Type of surveillance inspection Fee Schedule 5 Part 1
Full quality management system surveillance inspection (described in Schedule 3, Part 1) $8,800 Item 1.2(a)
Production quality management system surveillance inspection (described in Schedule 3, Part 4) $8,800 Item 1.2(a)
Product quality management system surveillance inspection (described in Schedule 3, Part 5) $8,800 Item 1.2(a)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Review of certificate of conformity assessment

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

Table 53: Review of certificate of conformity assessment
Type of certificate being reviewed Fee Schedule 5 Part 1
Design examination re-assessment (described in Schedule 3, Clause 1.6) $53,800 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type) (described in Schedule 3, Part 2) $41,500 Item 1.3(b)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

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.

Table 54: Additional inspection fees
Inspection costs Fee 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 $430/hour/assessor Item 2.1(b)
Costs and reasonable expenses of travel by each assessor involved, including travel both in and outside Australia costs and reasonable expenses Item 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 Item 2.2

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

Issuing quality systems certificates

Table 55: Issuing quality systems certificates
Certificate Fee
Quality systems certificate $180
Certified copy of quality systems certificate $70

IVD medical devices

Version 1.1, July 2019

25 July 2019

The TGA website has information about IVD regulation basics.

Sponsoring IVDs

Annual charges

Table 56: Annual charges
Class of IVD Charge Regulation
All classes of IVD (excluding Class 4 in-house IVDs) $680 7(4)(e)
Class 4 in-house IVDs n/a 7(4)(f)

These charges are in the Therapeutic Goods (Charges) Regulations 2018
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.

Table 57: Notification fee
Class of IVD Notification fee Schedule 5 Part 1
Notification by a laboratory of its Class 1, Class 2 or Class 3 in-house IVDs $1,040 Item 1.17

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

Application fees

These fees are to apply to include an IVD in the ARTG. Application audit assessment fees are often payable as well.

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

Table 58: Application fees
Application Application fee Regulation
Application for inclusion into the ARTG of all classes of IVD, including Class 4 in-house IVDs (excluding export only IVD devices) $1,040 Therapeutic Goods (Medical Devices) Regulations 2002,
Schedule 5 Part 1,
Item 1.5(h)
Variation to an ARTG inclusion entry $460 Therapeutic Goods Regulations 1990,
Schedule 9 Part 2 Item 2A(g)

These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990

Application for medical devices (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application to include an IVD in the ARTG.

Table 59: Application for medical devices (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $10,000 Item 1.5A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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.

Table 60: Application audit assessment fees
Type of IVD Assessment fee Schedule 5 Part 1
Class 1, Class 2 and Class 3 IVDs $6,990 Item 1.14A
Class 4 in-house IVDs $64,700 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,700 Item 1.14C

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

Manufacturing IVDs

Application for conformity assessment

Table 61: Application for conformity assessment
All conformity assessment procedures Fee Schedule 5 Part 1
Application fee $1,020 Item 1.1

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

Application for conformity assessment (priority applicant) determination

This fee is for applicants seeking Priority Review designation for an application for TGA conformity assessment of an IVD.

Table 62: Application for conformity assessment (priority applicant) determination
Application type Application fee Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $10,000 Item 1.1A

This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002

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.

Table 63: Initial assessment of conformity assessment
Type of conformity Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.9A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.9A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.9A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.9A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 Item 1.9A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Review of certificate of conformity assessment

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

Type of certificate being reviewed Fee Schedule 5 Part 1
Full quality management system inspection: described in Schedule 3, Part 1 $30,400 Item 1.3A(a)
Design examination: described in Schedule 3, Clause 1.6 $64,700 Item 1.3A(b)
Design examination - immunohaematology reagent: described in Schedule 3, Clause 1.6 $15,700 Item 1.3A(c)
Type examination: described in Schedule 3, Part 2 $41,900 Item 1.3A(e)
Production quality management system inspection: described in Schedule 3, Part 4 $26,700 Item 1.3A(f)

These fees are in Schedule 5 Therapeutic Goods (Medical Devices) Regulations 2002

Other IVD conformity assessment fees

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

Table 65: Other IVD conformity assessment fees
Other assessment for IVD conformity assessment Fee 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] $430/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 Item 2.1(a)
Surveillance assessment for conformity assessment certificate under Schedule 3, Part 1 or 4 $8,850 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD 60% of the relevant 'initial assessment' fee* under item 1.9A Item 1.10A(a)
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,990 Item 1.14A

Conformity assessment fees are in Schedule 5, Therapeutic Goods (Medical Devices) Regulations 2002
*: for relevant 'initial assessment' fees

Other listed and registered therapeutic goods (OTGs)

Version 1.1, July 2019

25 July 2019

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

Table 66: Annual charges
Type of OTG Charge Regulation
Listed OTG: tampons and disinfectants $860

Item 7(1)(c)(iii) and Item 7(2)(c)(iii)

Registered OTG - disinfectants $1,670

Item 7(1)(a)(iii) and Item 7(2)(a)(iii)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Listed OTG fees

Table 67: Listed OTG fees
Listed OTG fees Fee Schedule 9 Part 2
Application fee $460 Item 3(a)
Variation fee $460 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $18,600 Item 9C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Registered OTG fees

Table 68: Registered OTG fees
Registered OTG fee type Fee Schedule 9 Part 2
Low level registered device – disinfectant variation initial evaluation fee $3,740 Item 6B
Clinical trial notification (CTN) $370 Item 14A(a)
High level registered device - application fee $4,440 Item 2(c)
High level registered device - variation processing fee $460 Item 2A(e)
High level device – variation manufacturing and/or quality control – initial evaluation $9,270 Item 7(b)

These fees are in Therapeutic Goods Regulations 1990

Miscellaneous fees

Table 69: Miscellaneous fees
Application type Fee 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. $480 Item 1A

This fee is in Schedule 9, Therapeutic Goods Regulations 1990

Clinical trials

Version 1.1, July 2019

25 July 2019

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.

Table 70: Unapproved medicines
Unapproved medicines Fee Schedule 9 Part 2
Clinical trial notification (CTN) $370 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,760 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,900 Item 1(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Unapproved biologicals

These fees for clinical trials of unapproved biologicals.

Table 71: Unapproved biologicals
Biologicals Fee Schedule 9A Part 2
Clinical trial notification (CTN) $370 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 17(b)
Clinical trial exemption (CTX) $26,600 Item 16

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

Unapproved medical devices (including IVDs)

These fees for clinical trials of unapproved medical devices and IVDs.

Table 72: Unapproved medical devices (including IVDs)
Unapproved medical devices (including IVD) Fee Schedule 5 Part 1
Clinical trial notification (CTN) $370 Item 1.8
Clinical trial exemption (CTX) $18,600 Item 1.7

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

Unapproved other therapeutic goods

These fees for clinical trials of unapproved other therapeutic goods.

Table 73: Unapproved other therapeutic goods
Unapproved other therapeutic goods Fee Schedule 9 Part 2
Clinical trial notification (CTN) $370 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $370 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,800 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $18,600 Item 1(c)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Advertising

Version 1.1, July 2019

25 July 2019

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.

Table 74: Specified media excluding broadcast media
Type of advertisement in specified media Fee Schedule 9 Part 2
Advertisement* intended for publication in the classified advertisements column of a newspaper or other printed publication $130 Item 17(a)(iv)
Advertisement* of 100 words or less $260 Item 17(a)(i)
Advertisement* of more than 100 words but of 300 words or less $310 Item 17(a)(ii)
Advertisement* of more than 300 words (including an advertorial) $480 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. $1,210 Item 17A(a)(i)
Still cinema advertisement* (including outdoor media) of 100 words or less $260 Item 17A(a)(vi)(A)
Still cinema advertisement* (including outdoor media) of more than100 words but of 300 words or less $310 Item 17A(a)(vi)(B)
Still cinema advertisement* (including outdoor media) of more than 300 words. $480 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) $130 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 Item 17(d) and Item 17A(d)
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 Item 17(e) and 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 17(b) and Item 17A(b)

Fees are in in Schedule 9, Therapeutic Goods Regulations 1990
* 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.

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

Table 75: Broadcast media
Type of advertisement in broadcast media Fee 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 $1,210 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 $640 Item 17A(a)(ii)
Television advertorial* greater than 150 seconds in length

$920 for first minute of script and $260 for each additional minute or part minute

Item 17A(a)(iii) (A) and Item 17(A)(a)(iii)(B)
Radio Advertisement* including up to 6 variations of the advertising concept for the same product $450 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 $320 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)

Fees are in Schedule 9 to the Therapeutic Goods Regulations 1990.
* Any additional time beyond one hour is charged at the rate of $210/hour

General fees

Version 1.1, July 2019

25 July 2019

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 notice declarations made before 15 September under regulation 43AAE(2) of the Therapeutic Goods Regulations 1990 attract a late declaration fee.

Table 76: Fees related to annual charge exemption (ACE) scheme
Number of ARTG entries Late declaration fee Regulation
If the declaration relates to not more than 5 entries in the ARTG $430

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

$430 for first 5 entries + $50 for each additional entry

Schedule 9 Part 2 Item 3AB(b)

Schedule 9A Part 2 Item 3A(b)

Fees are in the Therapeutic Goods Regulations 1990

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
Table 77: Fees related to a request to revoke an ARTG entry cancellation
Number of ARTG entries Fee for revocation of cancellation Regulation
If the request relates to one entry in the ARTG $160

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

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

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

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

$160 for first entry +

$50 for each additional entry

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

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

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

Fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990

Version history

Version 1.1, July 2019

25 July 2019
Version Description of change Author Effective date
V1.0 Original publication for the financial year July 2019 to June 2020 Regulatory Services and Drug Control Branch 01/07/2019
V1.1 Inclusion of export only IVD device application fee (table 33) and minor editorial changes Regulatory Services and Drug Control Branch July 2019