You are here
Fees and charges: summary - from 1 July 2018
Print version
Version 1.2, January 2019
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) |