Low turnover manufacturers

7 March 2017

Annual charges for a licence to manufacture a therapeutic good may be reduced by 50% if the wholesale turnover of that good is below a prescribed level.

Key points

  • Applications must be made by the due date of the invoice for each financial year in which an annual charge may be payable together with evidence of the wholesale turnover of manufacture.
  • Wholesale turnover of a therapeutic good is the value of turnover of that good as supplied in Australia in a financial year, exclusive of GST.
  • Applications should be signed by a Client Representative.
  • Penalties apply under the Crimes Act 1914 and the Criminal Code Act 1995 for making false or misleading statements and providing false or misleading information or documents.
  • The TGA may require additional documentation or inspect records in relation to applications.
  • Applicants will be notified of a decision to grant a reduction in writing. The reduction does not apply to an annual charge for a licence to manufacture human blood and blood components.

Procedure - the manufacturer

Applications must be made by the due date for payment of an invoice for an annual charge. Invoices are issued at the commencement of each new financial year.

The TGA will not accept low turnover applications received after the due date for payment of an annual licence charge.

Manufacturers must advise the TGA if the actual turnover exceeds the reduction threshold. At any time during the year, the full annual charge may be payable if the actual turnover for the year exceeds the estimated turnover provided in the application.

Procedure - the TGA

The TGA will approve an application where the delegate of the Secretary is satisfied that the wholesale turnover of therapeutic goods is less than the amount prescribed in the Regulations.

The TGA will notify manufacturers, usually within 30 days, as to whether a reduction has been approved. The full annual charge is payable if an application has been declined.

The TGA undertakes a post-approval sample program to validate applications for reductions to annual licence charges. This may require manufacturers to supply details of the actual turnover of manufactured goods in respect of a financial year. The TGA may also inspect manufacturers' records of sales.

Forms

Not applicable

Assistance

TGA Revenue Manager: Fax 02 6232 8222 or email accountsrec@health.gov.au.

References

Therapeutic Goods (Charges) Act 1990

  • Subsection 4(2) establishes annual charges in respect of licenses.

Therapeutic Goods (Charges) Regulations 1990

  • Rates of annual charges.

Therapeutic Goods Regulations 1990

  • Regulation 43AAJ(1) sets the wholesale turnover threshold for a reduction to a manufacturing licence charge.
  • Regulation 43AAJ(2) provides that reductions of annual charges do not apply in relation to a licence for the manufacture of human blood and blood components.

Summary of fees and charges

  • Summary of fees and charges - includes the annual charges payable for different classes of manufacturing licences and the wholesale turnover threshold for reductions to licence charges for the current year.