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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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General fees

Transfer of sponsorship

There are no fees for the transfer of sponsorship. However, there are fees associated with some changes to therapeutic goods that need to occur as a result of sponsor transfer, such as changes to registered medicine labels or variation of ARTG entry following acceptance of a new Manufacturer Evidence.

Fees related to annual charges exemption (ACE) scheme

To maintain an annual charge exemption, sponsors are able to self-declare that their product had no turnover. Self-declarations must be submitted to the TGA between 1 July and 22 July each year or it will be assumed that the product generated greater than $0 turnover.

Late notice declarations made before 15 September under regulation 43AAE(2) of the Therapeutic Goods Regulations 1990 attract a late declaration fee.

Table 76: Fees related to annual charge exemption (ACE) scheme
Number of ARTG entries Late declaration fee Regulation
If the declaration relates to not more than 5 entries in the ARTG $430

Schedule 9 Part 2 Item 3AB(a)

Schedule 9A Part 2 Item 3A(a)

If the declaration relates to 6 or more entries in the ARTG

$430 for first 5 entries + $50 for each additional entry

Schedule 9 Part 2 Item 3AB(b)

Schedule 9A Part 2 Item 3A(b)

Fees are in the Therapeutic Goods Regulations 1990

Fees related to a request to revoke an ARTG entry cancellation

There are fees for the requests for revocation of:

  • the voluntary cancellation of an ARTG entry by the sponsor
  • the cancellation of an ARTG entry that was cancelled due to non-payment of the annual charge
Table 77: Fees related to a request to revoke an ARTG entry cancellation
Number of ARTG entries Fee for revocation of cancellation Regulation
If the request relates to one entry in the ARTG $160

Therapeutic Goods (Medical Devices) Regulations 2002: Schedule 5, Part 1 Item 1.6A(a) and Item 1.6B(a)

Therapeutic Goods Regulations 1990: Schedule 9, Part 2 Item 6BA(a) and Item 6BB(a)

Therapeutic Goods Regulations 1990: Schedule 9A, Part 2 Item 16A(a) and Item 16B(a)

If the request relates to more than one entry in the ARTG

$160 for first entry +

$50 for each additional entry

Therapeutic Goods (Medical Devices) Regulations 2002: Schedule 5, Part 1 Item 1.6A(b) and Item 1.6B(b)

Therapeutic Goods Regulations 1990: Schedule 9, Part 2 Item 6BA(b) and Item 6BB(b)

Therapeutic Goods Regulations 1990: Schedule 9A, Part 2 Item 16A(b) and Item 16B(b)

Fees are in the Therapeutic Goods (Medical Devices) Regulations 2002 and Therapeutic Goods Regulations 1990

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