Fees and charges: summary - from 1 July 2017

Version 2.1, September 2017

Book pagination

6 September 2017

Prescription medicines

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

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

Annual charges

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

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

More about annual charges for chemical entities

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.

Higher annual charges

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

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

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

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

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

Prescription medicine application and evaluation fees

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

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

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

Requests with single fee

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

Prescription medicine request Fee Item in Schedule 9, Part 2
Variations to an ARTG entry, applied for under section 9D(3) of the Act, involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. $5,360 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,650 Item 2A(a)
Correction to an ARTG entry $1,650 Item 2A(a)
Self-assessable request with no evaluation of data $1,650 Item 2A(a)
Safety-related request with no evaluation of data $1,650 Item 2A(a)
Safety-related request with evaluation of data $5,360 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,170 Item 18
Application fee for registration applications under paragraph 23(2)(a) of the Act made within 30 days of cancellation from the ARTG, when cancellation of registration was due to failure to pay the annual charge $660 Item 2AA
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $460 Item 1A

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

Medicines as components of devices

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

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

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