Articles

This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

More prominent warnings are being added to the product information (PI) and consumer medicine information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

There may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.

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

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

Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.

Recall reforms program update and preview of the PRAC Version 1.0.

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

Find out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

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

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

We have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

From 28 October 2024, Telstra and Optus are switching off their 3G networks. Medical devices and products like personal medical alarms could be affected by these closures.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.

This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

Some medical device equipment could soon be affected as mobile network operators prepare to switch off their 3G networks.