Low turnover manufacturers
April 2007
Annual charges for a licence to manufacture therapeutic goods may be reduced by 50% if the wholesale turnover is below a prescribed level.
Key points
- Submissions must be submitted 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 in a financial year is the value of turnover of that good as supplied in Australia in that financial year, exclusive of GST.
- Submissions should be signed by an authorised officer. 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.
- Applicants will be notified of a decision to grant a reduction in writing.
- The TGA may require additional documentation or inspect records in relation to submissions.
- The reduction does not apply in relation to an annual charge payable in respect of a licence that for the manufacture of human blood and blood components.
Procedures
Manufacturers must write to the TGA requesting a reduction to the annual charge payable in respect of a manufacturing licence that is in force in a financial year, together with evidence of their wholesale turnover of the relevant therapeutic goods.
- Evidence may include inventory records, sales records, manufacturing batch records, standard cost information, management reports and financial statements.
Submissions should be submitted prior to or by the due date for payment of an invoice for an annual charge. Invoices are issued on the anniversary date of the licence.
Applications received after the due date for payment of an annual charge for a therapeutic good will not be considered for refund.
A submission will be approved where the delegate for the Secretary is satisfied that the wholesale turnover of therapeutic goods is less than the amount prescribed in the Regulations (see the Summary of Fees and Charges <http://www.tga.gov.au/docs/html/feesach.htm#fees> for details).
The wholesale turnover is the value of turnover of manufactured therapeutic goods supplied in Australia, excluding any GST that may be payable on the goods supplied.
Manufacturers will be notified, usually within 30 days, as to whether a reduction has been granted. The full annual charge is payable if a submission has been declined.
At any time during the year, the full annual charge may be payable if the actual turnover for the year exceeds an estimated turnover in a submission. Manufacturers must advise the TGA if the actual turnover exceeds the reduction threshold.
The TGA undertakes a post approval sample program to validate submissions 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 Manufacturer's records of sales.
Forms
Not applicable
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.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
- Subregulation 45A(1) sets the wholesale turnover threshold for a reduction to a manufacturing licence charge.
- Subregulation 45A(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 <http://www.tga.gov.au/docs/html/feesach.htm#fees>
- 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.