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Fees and charges: summary from 28 October 2021

Version 1.1, October 2021

18 November 2021

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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 66: Annual charges
Type of OTG Charge Regulation

Listed OTG: disinfectants

$890

Item 7(1)(c)(iii) and Item 7(2)(c)(iii)

Registered OTG: disinfectants

$1,720

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 67: Listed OTG fees
Listed OTG fee type Fee Schedule 9 Part 2

Application fee

$470

Item 3(a)

Variation fee

$470

Item 2A(ba)

Evaluation fee (if an evaluation is necessary) for assessing, whether a disinfectant is not safe for the purposes for which it is to be used

$19,200

Item 9B

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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 68: Miscellaneous fees
Application type Fee Schedule 9 Part 2

Where the application relates to a single entry in the register.

$500

Item 1A(a)

Where the application relates to two or more entries in the register.

$500 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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