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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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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 occur because 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 charge 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 notice declaration fee.

Table 74: Fees related to annual charge exemption (ACE) scheme
Number of ARTG entries Late notice declaration fee Schedule 9 Part 2
If the declaration relates to not more than 5 entries in the ARTG $440 Item 3AB(a)
If the declaration relates to 6 or more entries in the ARTG $440 for first 5 entries + $50 for each additional entry Item 3AB(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 75: 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 and

$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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