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Annual charges for therapeutic goods

24 July 2012

Annual charges apply to all product entries on the Australian Register of Therapeutic Goods (the Register).

Key points

• Annual charges are levied as a tax for cost recovery purposes.
• Annual charges relate to all therapeutic goods which are registered, listed or included on the Register at any time during the financial year to which the charge relates.
• 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 in the year of cancellation.
• Other than reductions for low value turnover (LVT), the TGA has no discretion to waive or reduce annual charges.
• Non-payment of annual charges for therapeutic goods will result in the cancellation of the entries on the Register. Once cancelled, a new application will be required to continue supply.
• Sponsor transfers of therapeutic products cannot be completed while annual charges remain outstanding.

Procedure

The TGA will issue an annual charge invoice following the approval of a new product entry on the Register for that financial year.

Before the start of each subsequent financial year, the TGA will invite sponsors to review their entries on the Register and make arrangements to cancel products no longer supplied and/or seek exemptions for LVT products.

In July each year, the TGA will issue invoices for all entries on the Register.

Sponsors are required to pay all annual charges in full by the due date.

Cancellations

The registration or listing of therapeutic goods in the Register may be cancelled under paragraph 30(2)(f) of the Act, (or suspended, under paragraph 29D(1)(b) of the Act) if the annual registration or listing charge is not paid within 28 days after it becomes payable.

The inclusion of a kind of medical device in the Register may be cancelled under subsection 41GL(f) of the Act, (or suspended under paragraph 41GA(1)(b) of the Act) if the annual charge payable in relation to the kind of medical device is not paid within 20 working days of the charge becoming payable.

Requests by sponsors for the Secretary to cancel entries for the registration, listing or inclusion of therapeutic goods off the Register can be made in writing using the relevant forms on the TGA website.

Transferring sponsors

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

• Sponsor cancellations - Authorisation to cancel a product from the Australian Register of Therapeutic Goods
• Application for declaration that turnover is of low value

Assistance

TGA Revenue Manager: Fax +61 2 6232 8222 or email accountsrec@tga.gov.au.

References

Therapeutic Goods (Charges) Act 1990

• Section 4 establishes annual charges.

Therapeutic Goods (Charges) Regulations 1990

• Rates of annual charges.
• Part 7 provides information on exemptions for annual charges for goods with low value turnover.

Therapeutic Goods Act 1989

• Section 44 prescribes when annual charges are due.
• Paragraphs 30(2)(f) and 41GL(f) provide for the cancellation of goods from the Register for non-payment of an annual charge.

Summary of fees and charges

• Summary of fees & charges- includes the annual charge payable for different classes of therapeutic goods for the current year.

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