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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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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 either a definition of a medical device or 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: tampons and disinfectants $860

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

Registered OTG - disinfectants $1,670

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 fees Fee Schedule 9 Part 2
Application fee $460 Item 3(a)
Variation fee $460 Item 2A(f)
Fee for evaluating documents and information relating to the safety of a listed therapeutic device $18,600 Item 9C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Registered OTG fees

Table 68: Registered OTG fees
Registered OTG fee type Fee Schedule 9 Part 2
Low level registered device – disinfectant variation initial evaluation fee $3,740 Item 6B
Clinical trial notification (CTN) $370 Item 14A(a)
High level registered device - application fee $4,440 Item 2(c)
High level registered device - variation processing fee $460 Item 2A(e)
High level device – variation manufacturing and/or quality control – initial evaluation $9,270 Item 7(b)

These fees are in Therapeutic Goods Regulations 1990

Miscellaneous fees

Table 69: Miscellaneous fees
Application type Fee Schedule 9 Part 2
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. $480 Item 1A

This fee is in Schedule 9, Therapeutic Goods Regulations 1990

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