Online payment of licence application fees by biological manufacturers

20 October 2016

We have identified a billing issue in our online systems. The issue affects Australian manufacturers who only undertake the manufacture of biologicals, and concerns the invoicing and subsequent payment of the correct application fee for a manufacturing licence under 37(1)(g) of the Therapeutic Goods Act 1989.

In order to resolve this issue we request that applicants take the following steps:

  1. Applications for a biologicals only manufacturing licence should be completed and lodged online as usual using TGA Business Services, but not paid.
  2. Contact the TGA by emailing and provide the following information from your application: client ID, applicant name, tracking number, date lodged and invoice number. The email should be marked attention Manufacturers Assessment Support Section. We will then issue a new invoice for the correct fee and delete the old one.
  3. Upon payment of the new invoice the application will be processed by the TGA.

Please note that the following are not affected by this change:

  1. Licence application fees for the manufacture of medicines, bloods and/or blood components.
  2. Invoicing of inspection fees.

Enquiries in regard to this notice may be marked attention Manufacturers Assessment Support Section and directed to the TGA as follows:

Email:

Phone: 1800 446 443 (free call within Australia) or +61 2 6221 6881