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Annual charges for therapeutic goods

April 2007

Annual charges are payable in relation to all product entries on the Australian Register of Therapeutic Goods (ARTG).

Key points

  • Annual charges are levied as a tax for cost recovery purposes.
  • Annual charges relate to all therapeutic goods entered on the ARTG at any time in respect of a financial year.
  • A new product entry approved during a financial year will be liable for a full annual charge for that financial year in addition to the application or evaluation fee paid.
  • A company remains liable for annual charges for cancelled goods.
  • Other than low turnover exemptions, the TGA has no discretion to waive or reduce annual charges.
  • Non payment of annual charges for therapeutic goods and devices will result in the cancellation of the relevant entries from the ARTG. Once cancelled, a new application would be required to continue supply.
  • Sponsor transfers of therapeutic products cannot be completed whilst annual charges (including instalments) remain outstanding.

Procedure

An annual charge invoice will be issued following the approval of a new product entry on the ARTG in respect of the current financial year.

Prior to the commencement of each subsequent financial year, the TGA will invite sponsors to review their entries on the ARTG and make arrangements to cancel products no longer supplied and/or seek exemptions for low turnover products.

In September each year, invoices will be issued for all product entries (other than exempted low turnover products) on the ARTG.

Invoices may be provided electronically. Sponsors may register their email addresses by submitting the appropriate form.

Sponsors may elect to pay annual charges in full by the due date, or by instalment. Instalment due dates are set out on the invoice. An instalment notice will be issued prior to the due date for payment.

Annual charges (including instalments) for therapeutic goods entries that remain outstanding by more than 28 days (20 working days for medical devices) may be cancelled. The TGA is not obligated to provide reminder notices or statements.

  • The TGA will write to a Sponsor notifying its intention to cancel the relevant therapeutic goods or devices thirty (30) days after the date of the notice.
  • A sponsor may request a review of the decision to cancel a registration, listing or inclusion from the ARTG within 90 days of publication of the decision.
  • Otherwise, once an entry of a therapeutic good has been cancelled, a fresh application is required for the continued supply. The application will result in a new entry on the ARTG, and full application and/or evaluation fees are payable.

Details of cancellations of therapeutic goods (including medical devices) will be published in the Commonwealth Gazette.

Following receipt of a request to transfer one or more therapeutic products to another sponsor, the TGA will check the status of annual charges invoices.

  • The existing sponsor remains liable for any amount outstanding for annual charges.
  • Transfers cannot be completed where a balance remains owing for annual charges.

Forms

Assistance

TGA Revenue Manager: Facsimile 02 6232 8222 or by email to .

References

Therapeutic Goods (Charges) Act 1990

  • Section 4 establishes annual charges.
  • Paragraphs 30(2)(f) and 41GL(f) provide for the cancellation of a good for non-payment of an annual charge.

Therapeutic Goods (Charges) Regulations 1990

  • Rates of annual charges.
  • Sub-Regulation 4B(1) provides an exemption where the turnover of a good is declared to be of low-value and low-volume.

Therapeutic Goods Act 1989

  • Section 44 prescribes when annual charges are due.

Summary of fees and charges <http://www.tga.gov.au/docs/html/feesach.htm#fees>

  • Includes the annual charge payable for different classes of therapeutic goods for the current year.

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