Annual charges for manufacturing licences
April 2007
Annual charges are payable by holders of a licence to manufacture therapeutic goods.
Key points
- Annual charges are levied as a tax for cost recovery purposes.
- Annual charges for manufacturing licences apply in relation to a licence held at any time in respect of a financial year.
- A new licence approved during a financial year will be liable for a full annual charge in addition to the application and inspection fees paid.
- A company remains liable for annual charges in a financial year in which a manufacturing licence is returned, suspended or revoked.
- Other than reductions for low turnover manufacturers (discussed in the guideline "Low Turnover Manufacturers"), the TGA has no discretion to waive or reduce annual charges.
- Non payment of an annual charge will result in the revocation or suspension of a manufacturing licence. Once revoked, a new licence must be sought to continue to manufacture therapeutic goods.
Procedure
An annual charge invoice will be issued following the approval of a new manufacturing licence in respect of the current financial year.
Thereafter, invoices for annual charges will be issued on the anniversary date of the licence for each financial year.
A manufacturer with a wholesale turnover of therapeutic goods below the level prescribed in the Regulations may seek a 50% reduction of the licence charge after receiving an invoice (see Low turnover manufacturers) <http://www.tga.gov.au/fees/ac-lowturnover.htm>.
Invoices may be provided electronically. Manufacturers may register their email addresses for receiving e-invoices by submitting the appropriate form.
Manufacturing licences must be paid in full by the due date. A licence overdue by more than 28 days may be suspended or revoked. The TGA is not obligated to provide reminder notices or statements.
Manufacturers will be provided with notice that a manufacturing licence has been revoked. Details of the revocation will be published in the Commonwealth Gazette.
A company may request a review of the decision to revoke a manufacturing licence within 90 days of the gazettal notice, enclosing reasons for the review.
Forms
- Election to receive invoices via the Internet
<http://www.tga.gov.au/fees/forms/elecbilling.htm>
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
Therapeutic Goods (Charges) Act 1990
- 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.
- Paragraph 41(1)(f) provides for the revocation of a licence for non-payment of an annual charge.
Therapeutic Goods Regulations 1990
- Sub-Regulation 45A(1) sets the turnover threshold for a reduction to a manufacturing licence charge.