Information & notices about TGA fees & payments

General information & notices

• Australian Government funding for biologicals
  Provides guidance on applying for Australian Government funding for Australian publicly funded facilities and not-for-profit hospital supply units for biologicals
• Cancellation of a therapeutic good for non-payment of an annual charge
  Therapeutic products entered on the Australian Register of Therapeutic Goods (the Register) may be cancelled by the TGA for non-payment of an annual charge
• Refunds
  With few exceptions, the TGA's regulatory fees and charges are non-refundable and non-transferable

Annual charges

• 2013 important financial dates for all sponsors
  Information for sponsors on important financial dates for 2013
• Annual charges for therapeutic goods
  Annual charges apply to all product entries on the Australian Register of Therapeutic Goods (ARTG)
• Applying for low value turnover exemption from annual charges
  A sponsor can seek exemption from the liability to pay an annual charge for an entry on the Australian Register of Therapeutic Goods (the Register) if the therapeutic good qualifies for low value turnover (LVT)
• New register entries - Annual charges and Low Value Turnover (LVT) - Legislation change
  Regulation 43AAA of the Therapeutic Goods Regulations 1990 (the Regulations) was amended on 9 December 2011 to allow an additional one month for payment of the annual charge and lodgement of Low Value Turnover (LVT) applications for new entries on the Australian Register of Therapeutic Goods (the Register)

Manufacturers

• Annual charges for manufacturing licences
  Holders of a licence to manufacture therapeutic goods are required to pay an annual licence charge
• Low turnover manufacturers
  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
• Revocation of a manufacturing licence
  The TGA can suspend or revoke a manufacturing licence if the annual licence charge is not paid in time