Revocation of a manufacturing licence
April 2007
Manufacturing licences may be suspended or revoked by the TGA for the non-payment of an annual licence charge.
Key points
- A manufacturing licence may be revoked for the non-payment of an annual licence charge.
- Revocation of a manufacturing licence will take effect on the date of the notice provided by the TGA.
- It is an offence to continue to manufacture, supply or export a therapeutic good after a licence has been revoked.
- Decisions to revoke a licence are published in the Commonwealth Gazette.
- A Manufacturer may seek a review of the decision to revoke a licence for non-payment of an annual charge.
Procedures
Annual licence charges are payable with respect to a manufacturing licence in force at any time during a financial year.
The TGA may suspend or revoke a manufacturing licence for the non payment of annual licence charges by the due date for payment.
The TGA will write to a Manufacturer notifying its intention to revoke a manufacturing licence, usually thirty (30) days from the date of the notice. Manufacturers may provide a written submission setting out the circumstances why cancellation should not proceed, together with the overdue payment.
Where no submission has been made by a Manufacturer by the required date (or where the delegate is not satisfied with the matters set out in a Manufacturer's submission), the TGA will proceed to revoke the manufacturing licence for non-payment.
A notice of the decision will be provided to the Manufacturer and details will be published in the Commonwealth Gazette.
Once revoked, the TGA cannot restore the licence and a Manufacturer must apply for a new licence. All relevant application and inspection fees are payable in full.
Revocation of a manufacturing licence for non-payment is an initial decision within the meaning of subsection 60(1) of the Therapeutic Goods Act.
Manufacturers may request a review of the decision to revoke a manufacturing licence within 90 days of the gazettal notice.
It should be noted that annual charges are debts owing to the Commonwealth. Manufacturers remain liable for the payment of any outstanding amount owing following the revocation of a licence at their own request.
Forms
Not applicable
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
Therapeutic Goods Act 1989
- Paragraph 41(1)(f) provides for the revocation of a licence for non-payment of an annual charge.
- Subsection 60(1) review of decisions.