Standard conditions of approval

The Therapeutic Goods Administration (TGA) grant Section 19A approvals, for a specified period, which usually coincides with the period that the medicine on the ARTG is unavailable or in short supply. However, approval may lapse early if:

  • a decision has been made about whether or not to register the medicine in Australia;
  • any of the specific criteria for approval no longer apply (for example, the registered medicine is no longer in short supply);
  • a condition of approval has been breached.

Section 19A approvals are subject to a number of conditions specified by the TGA including the following (though additional conditions can be imposed where the circumstances warrant it):

  • the approval applies only to the medicine specified in the approval;
  • the approval is only for importation into and supply within Australia;
  • the medicine is sourced from manufacturers with acceptable evidence of Good Manufacturing Practice (GMP);
  • a letter to health professionals who will be prescribing the medicine is usually required;
  • the goods must be labelled with the name and address of the approval holder to ensure that adverse events can be reported.

Further information on current Section 19 approvals is available at: https://www.tga.gov.au/ws-s19a-index

TGA, 5 November 2018 ; http://www.tga.gov.au/