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Fees and charges: summary from 1 July 2020
Version 1.3, November 2020
Other listed and registered therapeutic goods (OTGs)
Other listed and registered therapeutic goods (OTGs) include:
OTGs are the goods that meet the definition of a therapeutic good, but do not meet the definition of a medical device, 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.
- For information about manufacturing OTGs, go to Manufacturing medicines and OTGs
- For export information, go to Device export certificates
- For clinical trials involving unapproved OTGs, go to Clinical trials.
Annual charges
| Type of OTG | Charge | Regulation |
|---|---|---|
| Listed OTG: disinfectants | $880 | Item 7(1)(c)(iii) and Item 7(2)(c)(iii) |
| Registered OTG: disinfectants | $1,700 | Item 7(1)(a)(iii) and Item 7(2)(a)(iii) |
These charges are in the Therapeutic Goods (Charges) Regulations 2018
Listed OTG fees
| Listed OTG fee type | Fee | Schedule 9 Part 2 |
|---|---|---|
| Application fee | $470 | Item 3(a) |
| Variation fee | $470 | Item 2A(ba) |
These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* Fee for evaluating documents and information relating to the safety of a listed OTG will be in Schedule 9, Therapeutic Goods Regulations 1990 - regulatory changes pending
Miscellaneous fees
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
| Application type | Fee | Schedule 9 Part 2 |
|---|---|---|
| Where the application relates to a single entry in the register. | $490 | Item 1A(a) |
| Where the application relates to two or more entries in the register. |
$490 for the first entry plus $100 for each additional entry |
Item 1A(b) |
This fee is in Schedule 9, Therapeutic Goods Regulations 1990