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Fees and charges: summary from 28 October 2021

Version 1.1, October 2021

18 November 2021

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Prescription medicines

These fees apply to prescription medicines and other medicines 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

$7,490

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

$4,260

Item 8(2)(a)

Non-biological medicine (chemical entity) - otherwise

$3,470

Item 8(2)(b)

Provisionally registered biological medicine

$16,900

Item 9(1)(a)

Provisionally registered non-biological medicine

$13,800

Item 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 or 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*

$50,300

$201,600

Item 2(ba) and Item 4(a)

Extension of indications*

$30,000

$119,600

Item 2(bd) and Item 4(b)

Major variations*^

$19,600

$78,000

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)^

$1,150

$4,590

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*^

$1,150

$4,590

Item 2AC and Item 2C

Additional trade name^

$3,170

$12,600

Item 2(bh) and Item 4(d)

New generic product*

$19,400

$77,000

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

$1,150

$4,590

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

$13,100

n/a

Item 1B

New prescription medicine in the priority pathway

$53,300

$213,200

Item 2(bca) and Item 4(ab)

New indications medicine in the priority pathway

$31,700

$126,800

Item 2(bfa) and Item 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

$13,100

n/a

Item 1AA

Extension of provisional determination

$4,750

n/a

Item 1AB

Provisional registration of a new prescription medicine

$50,400

$263,000

Item 1AC(a) and Item 1AD(a)

Provisional registration of a new indications medicine

$30,100

$173,500

Item 1AC(b) and Item 1AD(b)

Extension of provisional registration

$18,100

n/a

Item 1AG

Transition from provisional registration to full registration*

$30,000

$126,500

Item 1AE and Item 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 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.

$5,740

Item 2B

Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data

$1,760

Item 2A(a)

Correction to an ARTG entry

$1,760

Item 2A(a)

Notification request

$840

Item 2CB

Self-assessable request with no evaluation of data

$1,760

Item 2A(a)

Safety-related request with no evaluation of data

$1,760

Item 2A(a)

Safety-related request with evaluation of data

$5,740

Item 2CA

Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit

$2,320

Item 18

Request for early scientific advice on a biowaiver justification

$8,660

Item 1ABA

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 where the application relates to a single entry in the register.

$500

Item 1A(a)

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 where the application relates to two or more entries in the register.

$500 for the first entry,

plus $100 for each additional entry

Item 1A(b)

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

$16,700

$67,300

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

$33,500

$134,100

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

$9,970

$39,900

Item 2(be)(i)

Item 4(bb)(i)

Item 4(bb)(ii)

Extension of indications of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies

$20,100

$79,700

Item 2(bf)(i)

Item 4(bb)(iii)

Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies

$6,510

$25,900

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

$13,000

$52,100

Item 2(bf)(ii)

Item 4(bb)(iii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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