Fees and charges: summary - from 4 December 2017

Version 2.2, December 2017

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4 December 2017

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

Number of ARTG entries Late declaration fee Item in schedule of Therapeutic Goods Regulations 1990
If the declaration relates to not more than 5 entries in the ARTG $410

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

$410 for first 5 entries +

$50 for each additional entry

Schedule 9 Part 2 Item 3AB (b)

Schedule 9A Part 2 Item 3A (b)

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
Number of ARTG entries Fee for revocation of cancellation Legislation
If the request relates to one entry in the ARTG $150

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

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

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

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

$150 for first entry +

$50 for each additional entry

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

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

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

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