Articles

We have issued 5 infringement notices totalling $19,800 to a health practitioner and an individual for the alleged unlawful importation of unapproved cosmetic injectables.

Information for health professionals about medicines with safety related updates to their Product Information.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

We have expanded our priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety.

We have identified reports of FluMist being administered in error to children under 2 years of age.

Medicinal cannabis prescribing in Australia has increased significantly in recent years. However, many patients are unaware that most medicinal cannabis products are unapproved goods. As a prescriber, you play a critical role in ensuring patients are informed, protected and supported when these products are being considered for their clinical situation.

Understanding the difference between an approved and unapproved therapeutic good can help you make informed decisions and have meaningful conversations with your healthcare practitioner, especially when considering treatments like medicinal cannabis.

We have published the outcomes from the targeted consultation, roundtable and stakeholder discussions reviewing certain Authorised Prescriber (AP) scheme requirements for accessing MDMA and psilocybine.

When medicines are in short supply, it can sometimes make patient care more difficult for health practitioners.
We aim to provide clear, timely information to help you access the medicines your patients need during a national medicine shortage. When appropriate, we also make other medicines available so patient care can continue.

ANDEXXA is no longer provisionally approved for use in Australia and has been removed from the Australian Register of Therapeutic Goods (ARTG).

We have issued 27 infringement notices, totalling $101,412, to a NSW-based individual for the alleged unlawful supply of Melanotan II to Australian consumers in contravention of the Therapeutic Goods Act 1989.

We have led Australia's participation in INTERPOL's Operation Pangea XVIII, a coordinated global action targeting the illegal trade of illicit and counterfeit therapeutic goods.

The Prescription Medicines in Pregnancy database has been updated to include new entries and amend some existing entries.

Cases of medication errors have been identified internationally where tranexamic acid injection was inadvertently administered to the spinal cord, resulting in severe pain, seizures, cardiac arrhythmias and deaths.

You might see a good deal on an overseas website, however, these health products are not approved for supply in Australia and have not been assessed by the TGA for safety, quality or effectiveness. You are not only risking your health, but you may also be left out of pocket if your online purchase is stopped at the border.

We have published new guidance on Manufacturing, supplying and advertising compounded medicines lawfully, to support compliance with Australia’s regulatory requirements.

Sponsors and manufacturers intending to export medicines and medical devices to Indonesia should be aware of new and emerging halal certification requirements under Indonesia’s Halal Product Assurance framework.

Do you know that there are strict rules when it comes to advertising therapeutic goods? If you see an ad that looks like it’s breaking the rules, report it using our online portal.

The TGA initiated targeted compliance reviews of select listed medicines containing Magnesium to verify whether sponsors had appropriate evidence to support their medicine’s exercise performance claims.

The Therapeutic Goods Administration (TGA) has published decisions relating to manufacturing licences for therapeutic goods.

The Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. An individual was also ordered to pay $250,000.

We have issued 4 infringement notices totalling $79,200 to Switch Nutrition Pty Ltd (Switch Nutrition) for the alleged unlawful advertising of therapeutic goods.

The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989.

We have issued an enforceable direction to Veganic SKN Limited on the basis that a delegate of the Secretary believes that Veganic SKN is not complying with the Therapeutic Goods Act 1989.

Information for health professionals about medicines with safety related updates to their Product Information.