Annual charges for manufacturing licences

7 March 2017

Holders of a licence to manufacture therapeutic goods are required to pay an annual licence charge.

A licence is required to manufacture a therapeutic good in Australia, irrespective of whether or not that good is listed on the Australian Register of Therapeutic Goods (the Register) for sale within Australia.

Key points

  • Annual charges are levied as a tax for cost-recovery purposes.
  • Annual charges for manufacturing licences apply to a licence that is in force at any time during the financial year to which the charge relates.
  • A new licence approved during a financial year will be charged the full annual licence charge in addition to the application and inspection fees paid.
  • A company remains liable for full annual licence charges in a financial year in which a manufacturing licence is returned, suspended or revoked.
  • Other than reductions for low turnover manufacturers (please see low turnover manufacturers), the TGA has no discretion to waive or reduce annual licence charges.
  • Non-payment of an annual licence charge will result in the revocation or suspension of a manufacturing licence.

Procedure

The TGA will issue an annual charge invoice following the approval of a new manufacturing licence for the current financial year.

Thereafter, invoices for annual charges will be issued at the commencement of each new financial year.

A manufacturer with a turnover of therapeutic goods below the level prescribed in Regulation 43AAJ can seek a 50% reduction of the annual licence charge after receiving an invoice (see low turnover manufacturers).

Revoking a licence

The TGA may suspend or revoke a licence if the annual licence charge or prescribed inspection fees have not been paid within 28 days after they become payable.

The TGA will notify a manufacturer of the intention to revoke or suspend a licence. To avoid revocation of the license the overdue amount should be paid upon receiving this notice.

Where no payment is received the TGA will provide written notification that the licence has been revoked. Details of the revocation will be published in the Commonwealth Gazette or on the TGA's website.

A manufacturer may request a review of the decision to revoke their license within 90 days of the cancellation notice being given to the manufacturer.

Once revoked, a new licence must be sought to continue to manufacture therapeutic goods.

Assistance

TGA Revenue Manager: Fax +61 2 6232 8222 or email accountsrec@health.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

  • Regulation 43AAJ sets the turnover threshold for a reduction to a manufacturing licence charge.