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Medicines Safety Update - Information for health professionals

We executed a search warrant on a residential property in Brisbane, with assistance from Queensland authorities. This was part of an investigation into the alleged importation, manufacture, supply, and advertising of unapproved therapeutic goods.

This instrument is made under subsection 19(7D) of the Therapeutic Goods Act 1989.

This instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

TGA has accepted a court enforceable undertaking from Yossef Wahib, operator of the online store Aussie Mega Supplements. Mr Wahib was also issued an infringement notice for $3,756.

The TGA has accepted a court enforceable undertaking from Yossef Wahib, operator of the online store Aussie Mega Supplements, in relation to alleged illegal manufacture, supply and advertising of unregistered therapeutic goods.

If your business is involved with medicinal cannabis, read our updated guidance about advertising medicinal cannabis to consumers.

We have issued infringement notices for $13,656 to 2 registered nurses for allegedly importing unapproved cosmetic injectables and advertising prescription-only medicines.

From 1 January 2024, the importation of disposable vapes will be prohibited, subject to very limited exceptions. Read more about the first stage of Australia’s vaping reforms.

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications.

We have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

If you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.

Be alert to new warnings of romosozumab (Evenity) cardiovascular risks for patients with a history of heart attack or stroke. If you're a health professional, read our Medicine safety update.

If you create content, you should know how to protect yourself and your business when it comes to promoting therapeutic goods.

We have alleged that the advertising on the company's website and social media was unlawful because medicinal cannabis products are prescription-only medicines that can't be advertised directly to consumers.

The changes will help address the significant public health issues caused by vaping in Australia, while keeping legitimate patient access to therapeutic vapes.

The TGA regulates medicines, implants, transfusions and vaccines—and also some common supermarket and health‑store products.

If you're a health professional, get the latest information about medicines with safety related updates to their Product Information.  

We have launched a new search feature in the Adverse Event Management System (AEMS) portal.  As a sponsor, you can access adverse event reports about your medicines and biologicals.

We've worked with the Australian Border Force to keep more than 307,000 units of unlawfully imported medicines and medical devices out of the Australian market.

We have issued 45 infringement notices totalling $742,500 to InstantScripts Pty Ltd for the alleged unlawful advertising of prescription-only medicines.