Fees and charges: summary - from 1 July 2018

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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 2018.

Type of prescription medicine Charge Regulation
Biological medicine $7,120 7(1)(b) and 7(2)(b)
Non-biological medicine (chemical entity) - subsection 3-10 of regulation 8 $4,060 8(2)(a)
Non-biological medicine (chemical entity) - otherwise $3,290 8(2)(b)
Provisionally registered biological medicine $16,100 9(1)(a)
Provisionally registered non-biological medicine $13,100 9(1)(b)

More about annual charges for chemical entities

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:

  • 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

Standard prescription medicine processes

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
New chemical entity* $47,800 $191,800 Items 2(ba) and 4(a)
Extension of indications* $28,500 $113,800 Items 2(bd) and 4(b)
Major variations*^ $18,600 $74,200 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)^ $1,100 $4,360 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*^ $1,100 $4,360 Items 2AC and 2C
Additional trade name^ $3,020 $12,100 Items 2(bh) and 4(d)
New generic product* $18,400 $73,200 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 $1,100 $4,350 Items 2(bk) and 4(bc)

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

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 determination of a prescription medicine $12,500 n/a Item 1B
New prescription medicine in the priority pathway $50,700 $202,800 Items 2(bca) and 4(ab)
New indications medicine in the priority pathway $30,200 $120,600 Items 2(bfa) and 4(bd)

n/a: not applicable

Provisional approval pathway

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
Provisional determination of a prescription medicine $12,500 n/a Item 1AA
Extension of provisional determination $4,520 n/a Item 1AB
Provisional registration of a new prescription medicine $47,900 $250,200 Items 1AC(a) and 1AD(a)
Provisional registration of a new indications medicine $28,600 $165,000 Items 1AC(b) and 1AD(b)
Extension of provisional registration $17,200 n/a Item 1AG
Transition from provisional registration to full registration* $28,500 $120,300 Items 1AE and 1AF

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. 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. $5,460 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,680 Item 2A(a)
Correction to an ARTG entry $1,680 Item 2A(a)
Notification request $790 Item 2CB
Self-assessable request with no evaluation of data $1,680 Item 2A(a)
Safety-related request with no evaluation of data $1,680 Item 2A(a)
Safety-related request with evaluation of data $5,460 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,210 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. $470 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 $15,900 $64,000 Items 2(bb), 4(aa)(i), 4(aa)(ii)
New chemical entity of a medicine used as an ancillary medical component of a device $31,900 $127,600 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 $9,490 $37,900 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 $19,100 $75,800 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 $6,190 $24,600 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 $12,400 $49,600 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.

Listing applications

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

Listed medicine fee or charge Amount Legislation
Annual charge $1,120 Therapeutic Goods (Charges) Regulations 2018, regulations 7(1)(c)(i) and 7(2)(c)(i)
Application fee $820 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 3(b)
Processing fee (variation to an existing listing) $420 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 $470 Item 1A

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

Permitted indication list

Applications for a new permitted indication have an application fee, which is in Schedule 9, Therapeutic Goods Regulations 1990.

Listed medicine fee or charge Amount Item in Schedule 9, Part 2
Application fee for a new indication to be added to the permitted indication list $1,040 Item 7C

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

Application Category Application fee Evaluation fee Item in Schedule 9, Part 4
IN1 $1,070 $14,300 Items 28 and 29
IN2 $1,070 $14,300 Items 30 and 31
IN3 $2,820 $23,300 Items 32 and 33
IN4 $2,820 $23,300 Items 34 and 35

Assessed listed complementary medicines

Annual charge for assessed listed medicines

Annual charge Amount Legislation
Annual charge $1,120 Therapeutic Goods (Charges) Regulations 2018, regulations 7(1)(c)(i) and 7(2)(c)(i)

Assessed listed applications

Applications for assessed listed complementary medicines (under section 26AE of the Act) have both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Application Category Application fee Evaluation fee Item in Schedule 9, Part 4
L(A)1 $440 $1,670 Items 22 and 23
L(A)2 $1,790 $13,700 Items 24 and 25
L(A)3 $1,790 $13,700 Items 26 and 27

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. 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 $10,500 Items 7A(a), 7A(b)(i), 7B(a), 7B(b)(i)
51-250 $13,500 Items 7A(b)(ii), 7B(b)(ii)
251-500 $18,400 Items 7A(b)(iii), 7B(b)(iii)
501-1000 $24,400 Items 7A(b)(iv), 7B(b)(iv)
1001-2000 $36,600 Items 7A(b)(v), 7B(b)(v)
2001-3000 $48,800 Items 7A(b)(vi), 7B(b)(vi)
>3000 $73,200 Items 7A(b)(vii), 7B(b)(vii)

Registered complementary medicines

Annual charges

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

Charge Amount Regulation
Annual charge $1,460 Regulation 7(1)(a)(i) and 7(2)(a)(i)

Application and evaluation fees for registered complementary medicines

Applications for registered complementary medicines have both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Application Category Application fee Evaluation fee Item in Schedule 9, Part 4
RCM1 $540 $3,120 Items 12 and 13
RCM2 $1,950 $20,900 Items 14 and 15
RCM3 $1,950 $20,900 Items 16 and 17
RCM4 $2,580 $28,300 Items 18 and 19
RCM5 $2,820 $36,200 Items 20 and 21

Changes: applications under section 23

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).

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

RCM change application category Application fee Evaluation fee Item in Schedule 9, Part 4
RCMC1 $1,410 N/A Item 5
RCMC2 $740 $4,040 Items 6 and 7
RCMC3 $790 $6,310 Items 8 and 9
RCMC4 $810 $9,330 Items 10 and 11

Changes: applications under section 9D

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 Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

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

RCM change application category Upfront fee Refund if no evaluation Item and Part in Schedule 9
Notification requests $790 N/A Part 2, items 2CC and 2CB
RCMC1 $1,410 N/A Part 4, item 1
RCMC2 $4,780 $4,040

Part 4, item 2

Regulation 43ACA(2)(a)

RCMC3 $7,100 $6,310

Part 4, item 3

Regulation 43ACA(2)(b)

RCMC4 $10,100 $9,330

Part 4, item 4

Regulation 43ACA(2)(c)

Other fees

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

Type of fee or charge Amount Legislation
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 $470 Item 1A, Part 2, 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

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

Medicine type Charge Regulation
Registered OTC medicine $1,460 Regulations 7(1)(a)(i) and 7(2)(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 $1,620 $4,000 Items 1(a) and 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $810 $4,000 Items 3(d) and 2(a)
N2 application $1,620 $5,680 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) $810 $5,680 Items 3(e) and 2(b)
N3 application $2,600 $8,750 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) $1,300 $4,430 Item 3(f) and 4(d)
N4 application $3,790 $14,500 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) $1,300 $4,430 Items 3(g)and 4(e)
N5 application $5,620 $21,500 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) $1,300 $4,430 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 $1,620 n/a Item 1(f)
C2 (section 23) application $1,620 $4,000 Items 1(g) and 2(f)
C3 (section 23) application $1,620 $6,710 Items 1(h) and 2(g)
C4 (section 23) application $2,600 $8,750 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. For information on application types, go to OTC application categorisation framework.

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

Application type Upfront fee Refund if no evaluation Therapeutic Goods Regulations 1990
CN (section 9D) notification request $790 n/a Schedule 9 Part 2 items 2CD and 2CB
C1 (section 9D) application $1,620 n/a Schedule 9 Part 3 Item 5
C2 (section 9D) application $5,620 $4,000

Schedule 9 Part 3 Item 6(a)

Regulation 43AC (2)(a)

C3 (section 9D) application $8,330 $6,710

Schedule 9 Part 3 Item 6(b)

Regulation 43AC (2)(b)

C4 (section 9D) application $11,400 $8,750

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 $1,590 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 $8,140 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. $470 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 2018.

Annual charges for manufacturing licences Charge Therapeutic Goods (Charges) Regulations 1990
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers $4,590 Regulation 7(5)(a-c, e)
Manufacturing licence charge for therapeutic device (other therapeutic good) $6,380 Regulation 7(5)(d)

Only highest applicable charge is payable.

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 $770 Item 8(a)
Application for variation of a manufacturing licence $770 Item 8A
Australian manufacturing sites - inspection fee $970/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 $1,360/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) $400 Item 6AA
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) $690 Item 6AB
Compliance verification (in lieu of an overseas GMP inspection) $2,070 Item 6ABA
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above $1,160 Item 6AC

Issuing manufacturing certificates

Certificate Fee
Certificate of GMP compliance $180
Mutual Recognition Agreement certificate $330

Certified copy of:

  • original GMP certificate
  • certificate of GMP compliance
$70

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 $180 Item 10
Certificate of listed product $180 Item 10
Certificate of exempt product $180 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 $820 Item 3(b)
Processing fee (variation to an existing listing) $420 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 $180 Item 10
Export certificate $180 Item 10

Export-only devices

This fee applies to include a medical device in the ARTG that is for export only. This fee does not apply to IVD devices. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Export only applications Fee Item in Schedule 5 Part 1
Application for inclusion into the ARTG of export only devices (excluding IVDs) $90 Item 1.5(f)

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 7(5)(j) Therapeutic Goods (Charges) Regulations 2018].

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 $1,090 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,500 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,300 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $670/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 2018.

ARTG inclusion of biologicals Amount Therapeutic Goods (Charges) Regulations
Class 1 biological annual charge for ARTG inclusion $670 Regulation 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,620 Regulation 7(3)(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 $23,400 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,090 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,090 Item 2
Variation application fee - all classes $1,090 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $72,200 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,620 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $144,400 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $234,700 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $34,200 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,400 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,620 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 2018.

Therapeutic good being manufactured Charge Therapeutic Goods (Charges) Regulations 2018
Blood and blood components (not HPCs) - primary manufacturing site $160,300 Regulation 7(5)(f)(i)
Blood and blood components (not HPCs) - a fixed (non-mobile) manufacturing site $7,890 Regulation 7(5)(f)(ii)
HPCs manufacturing site $6,900 Regulation 7(5)(g)

Only highest applicable charge is payable.

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 $1,020 Item 8(b)
Blood and blood components (not HPCs) - Australian primary manufacturing site - inspection fee $900/hour/inspector Item 9AB
Blood and blood components (not HPCs) - Australian manufacturing site other than the primary site - inspection fee $670/hour/inspector Item 9AC
HPCs - Australian manufacturing site inspection fee $670/hour/inspector Item 9AA
Human tissues that are not biologicals - Australian manufacturing site - inspection fee $670/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 $1,310 Item 9AD(a)
11-50 $11,200 Item 9AD(b)
51-100 $25,100 Item 9AD(c)
101-1000 $33,700 Item 9AD(d)
1001-3000 $52,600 Item 9AD(e)
3001-4000 $70,100 Item 9AD(f)
>4000 $85,500 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. $470 Item 1A

Medical devices

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

Sponsoring medical devices

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

Class of medical device Charge Therapeutic Goods (Charges) Regulations 1990
AIMD $1,160 Regulation 7(4) (d)
Class III $1,160 Regulation 7(4) (d)
Class IIb $900 Regulation 7(4)(c)
Class IIa $900 Regulation 7(4)(c)
Class I - sterile $620 Regulation 7(4)(b)
Class I - measuring function $620 Regulation7(4)(b)
Class I - other $90 Regulation7(4)(a)

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. Application fees for export only devices are not included in this section.

Class of medical device Application fee Item in Schedule 5 Part 1
AIMD $1,310 Item 1.5(a)
Class III $1,310 Item 1.5(b)
Class IIb $1,020 Item 1.5(c)
Class IIa $1,020 Item 1.5(d)
Class I - sterile $1,020 Item 1.5(e)
Class I - measuring function $1,020 Item 1.5(e)
Class I - other (excluding export only devices) $530 Item 1.5(g)

Note: Refer to page 23 for 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. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

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

Application type Application fee Item in Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device $9,840 Item 1.5A

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 $3,830 Item 1.13
Level 2 - Level 1 activities plus review of evidence of conformity $7,030 Item 1.14

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 $450 Item 2A(g)

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 $450 Item 1.15
Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device from the ARTG $7,030 Item 1.6

Conformity Assessment Bodies designation determination

These applications have both an application fee and an assessment fee. These fees are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Assessment fee Item in Schedule 5 Part 1
Full designation conformity assessment body determination $4,480 $73,100 Items 1.4A and 1.4D
Partial designation conformity assessment body determination (full QMS) $2,460 $52,500 Items 1.4B and 1.4E
Partial designation conformity assessment body determination (partial QMS or partial devices) $2,460 $52,500 Items 1.4C and 1.4F

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.

All conformity assessment procedures Fee Item in Schedule 5 Part 1
Application fee $1,000 Item 1.1

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

Application type Application fee Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device $9,840 Item 1.1A

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 $29,700 Item 1.9(a)
Design examination: Schedule 3, Clause 1.6 $58,300 Item 1.9(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $40,700 Item 1.9(c)
Verification (including management of testing, analysis, and reporting on verification tests): Schedule 3, Part 3 $28,400 Item 1.9(d)
Production quality management system inspection: Schedule 3, Part 4 $26,000 Item 1.9(e)
Product quality management system inspection: Schedule 3, Part 5 $22,200 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 $17,800 Item 1.10(a)
Design examination: Schedule 3, Clause 1.6 $35,200 Item 1.10(b)
Type examination (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $24,500 Item 1.10(c)
Production quality management system inspection: Schedule 3, Part 4 $15,400 Item 1.10(d)
Product quality management system inspection: Schedule 3, Part 5 $13,500 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 $8,620 Item 1.2(a)
Production quality management system surveillance inspection: Schedule 3, Part 4 $8,620 Item 1.2(a)
Product quality management system surveillance inspection: Schedule 3, Part 5 $8,620 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 $52,700 Item 1.3(a)
Type examination re-assessment (including management of testing, analysis, and reporting on examination of the type): Schedule 3, Part 2 $40,700 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 $420/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 $180
Certified copy of quality systems certificate $70

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 2018.

Class of IVD Charge Regulation
All classes of IVD excluding Class 4 in-house IVDs $670 7(4) (e)
Class 4 in-house IVDs n/a 7(4) (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 $1,020 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 and export-only IVDs $1,020 Item 1.5(h), Schedule 5 Part 1 Therapeutic Goods (Medical Devices) Regulations 2002
Variation to an ARTG inclusion entry $450 Item 2A(g) Schedule 9 Part 2 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. This fee is in the Therapeutic Goods (Medical Devices) Regulations 2002.

Application type Application fee Item in Schedule 5 Part 1
Medical devices (priority applicant) determination in relation to a medical device (including an IVD) $9,840 Item 1.5A

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 $6,850 Item 1.14A
Class 4 in-house IVDs $63,400 Item 1.14B
Class 4 in-house immunohaematology reagent IVD $15,400 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 $1,000 Item 1.1

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

Application type Application fee Item in Schedule 5 Part 1
Conformity assessment (priority applicant) determination in relation to a medical device (including an IVD) $9,840 Item 1.1A

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 $29,800 Item 1.9A(a)
Design examination: Schedule 3, Clause 1.6 $63,400 Item 1.9A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,400 Item 1.9A(c)
Type examination: Schedule 3, Part 2 $41,100 Item 1.9A(e)
Production quality management system inspection: Schedule 3, Part 4 $26,200 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 $29,800 Item 1.3A(a)
Design examination: Schedule 3, Clause 1.6 $63,400 Item 1.3A(b)
Design examination - immunohaematology reagent: Schedule 3, Clause 1.6 $15,400 Item 1.3A(c)
Type examination: Schedule 3, Part 2 $41,100 Item 1.3A(e)
Production quality management system inspection: Schedule 3, Part 4 $26,200 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] $420/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 $8,670 Item 1.2(b)
Assessment of changes to IVD or QMS for applicable IVD $17,800 Item 1.10A(a)
Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate $6,850 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 2018.

Type of OTG Charge Regulation
Listed OTG: tampons and disinfectants $840

Regulation 7(1)(c)(iii)

Regulation 7(2)(c)(iii)

Registered OTG - disinfectants $1,640

Regulation 7(1)(a)(iii)

Regulation 7(2)(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 $450 Item 3(a)
Variation fee $450 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $18,200 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 $1,460 Item 2(b),(g)
Low level registered device - disinfectant initial evaluation fee $18,200 Item 5B
Low level registered device - variation processing fee $450 Item 2A(d)
Low level registered device - disinfectant variation initial evaluation fee $3,660 Item 6B
Clinical trial notification (CTN) $360 Item 14A
High level registered device - application fee $4,350 Item 2(c)
High level registered device - variation processing fee $450 Item 2A(e)
High level device - variation manufacturing and/or quality control - initial evaluation $9,080 Item 7(b)
High level registered device - variation manufacturing and/or quality control - concurrent evaluation $2,000 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. $470 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) $360 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,720 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,500 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) $360 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 17(b)
Clinical trial exemption (CTX) $26,100 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) $360 Item 1.8
Clinical trial exemption (CTX) $18,200 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) $360 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,740 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $18,200 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 $130 Item 17 (a)(iv)
Advertisement* of 100 words or less $250 Item 17 (a)(i)
Advertisement* of more than 100 words but of 300 words or less $300 Item 17 (a)(ii)
Advertisement* of more than 300 words (including an advertorial) $470 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. $1,190 Item 17A (a)(i)
Still cinema advertisement* (including outdoor media) of 100 words or less $250 Item 17A(a)(vi)(A)
Still cinema advertisement* (including outdoor media) of more than100 words but of 300 words or less $300 Item 17A(a)(vi)(B)
Still cinema advertisement* (including outdoor media) of more than 300 words. $470 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 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 $1,190 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 $630 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 $440 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 $310 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 $420

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

$420 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 $160

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

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

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

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

$160 for first entry +

$50 for each additional entry

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

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

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

Version history

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Version Description of change Author Effective date
V1.0 Original publication for the financial year July 2018 to June 2019 Regulatory Services and Improvement Branch 01/07/2018
V1.1 Update to the application fee for export only devices (excluding IVDs) to be included on the ARTG, in accordance with Therapeutic Goods Legislation Amendment (2018 Measures No.3) Regulations 2018 Regulatory Services & Drug Control Branch 12/10/2018