Annual charges for therapeutic goods

Key points

• Annual charges are levied as a cost recovery tax.
• Annual charges relate to therapeutic goods which are registered, listed or included on the Register at any time during the financial year to which the charge relates (except export only entries)
• A new product entry approved during a financial year will automatically qualify for an ACE until the product generates turnover at which time the product becomes liable for the financial year’s annual charge.
• A company remains liable for annual charges for cancelled goods in the year of cancellation.
• TGA has the power to waive an annual charge under exceptional circumstances.
• Non-payment of annual charges will result in the cancellation of the entries from 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 a sponsors notification that turnover has commenced for a product.

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

Before the end of each 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 notify commencement of turnover.

Sponsors are required to pay the annual charges 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

Assistance

TGA Accounts Receivable Manager: Fax +61 2 6232 8222 or email accountsrec@health.gov.au.

References

Therapeutic Goods (Charges) Act 1989

• Section 4 establishes annual charges.

Therapeutic Goods (Charges) Regulations 1990

• Rates of annual charges.

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.

Therapeutic Goods Regulations 1990

• Part 7 provides information on annual charge exemptions and waivers.

Summary of fees and charges

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