Fees and charges: summary - from 1 July 2018

Version 1.1, October 2018

12 October 2018

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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 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)

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