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

21 September 2021

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: 31 July 2021
Section 19A approved medicine:

ERGONOVINE MALEATE INJECTION (Ergonovine Maleate Injection, USP) 0.25 mg/mL, 1 mL ampoules


Medicine in short supply/unavailable:

  • DBL ERGOMETRINE INJECTION Ergometrine maleate injection - ARTG 58866

Section 19A approval holder: Link Medical Products Pty Ltd ABN 73 010 971 516

Approval holder phone number: 1800 181 060

Prevention or treatment of postpartum or post-abortal hemorrhage due to uterine atony.

Please note:

  • The active ingredient ergometrine maleate is known as ergonovine maleate overseas.
  • The Australian registered product has a different concentration to the overseas product. Health professionals should take care when using Ergonovine maleate injection USP (0.25 mg/mL) ampoule to ensure the correct dosage is used.
  • The safety advisory statement for Ergometrine injection and its alternative under section 19A may be found at: https://www.tga.gov.au/alert/ergometrine-maleate-i...