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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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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.

Annual charges

Table 67: 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

Table 68: 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

Table 69: Miscellaneous fees
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

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