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Database of section 19A approvals to import and supply medicines to address medicine shortages

20 May 2022

This database provides information on medicines not on the Australian Register of Therapeutic Goods (ARTG) that are approved for import and supply in Australia because:

  • there is a shortage of a medicine registered in Australia; and
  • the medicine is needed in the interest of public health.

The database holds information on approvals current on or after 21 Feburary 2018. Contact the TGA's Medicines Shortages Section for information on approvals that expired or lapsed before 21 Feburary 2018.

Consumers can use medicines accessed under section 19A until the medicines expire.

The 'Import and supply approved until' date applies to the approval holder importing and supplying the medicine.

The Medicines Shortages Information Initiative lists medicines that are unavailable or in short supply. If you are having difficulty obtaining a treatment that has been prescribed to you, talk to your doctor or pharmacist.

Section 19A approvals are granted 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.

Section 19A approvals

Displaying 1 - 1 of 1

Enter an approval holder, product name, active ingredient, indication or ARTG number.
Import and supply approved until: 28 February 2024
Section 19A approved medicine:

VERSACLOZ (clozapine) 50 mg/mL oral suspension (TruPharma)

Medicine in short supply/unavailable:

  • CLOPINE SUSPENSION clozapine 50 mg/mL oral liquid bottle - ARTG 142239

Section 19A approval holder: Pfizer Australia Pty Ltd ABN 50 00 8422 348

Approval holder phone number: 1800 675 229

Treatment with VERSACLOZ is indicated only in people with treatment-resistant schizophrenia, i.e. people with schizophrenia who are non-responsive to, or intolerant of other antipsychotic drugs.