Therapeutic Goods Administration

Under the prescription model, pharmacists that dispense therapeutic vapes must meet certain regulatory obligations, including: • verifying that it’s appropriate and lawful to supply the vape • only supply products on our list of notified vapes. Pharmacists may dispense vapes with evidence of a prescription and one of the following: • Authorised Prescriber (AP) approval • Special Access Scheme (SAS) B approval • SAS C notification. Pharmacists can use the TGA reference number to check the validity of approvals and notifications through our SAS and AP Online System. Visit our website for more information: https://lnkd.in/deHwB7E8

We have published new guidance on our website regarding the strengthened standards for unapproved therapeutic vapes that will be implemented in stages during 2025: • From 1 March 2025, only products that meet the updated standards will be able to be imported into or manufactured in Australia. • From 1 July 2025, only products that meet the updated standards can be lawfully supplied in Australia. Visit our website to access the guidance: https://lnkd.in/gWTzD8cf

Medical devices and products like personal medical alarms could be affected by mobile network operators switching off 3G. From 28 October 2024, Telstra and Optus are switching off their third-generation networks. All providers have released information to help people update their phones and plans. Seek help from your supplier or place of purchase if you think your device might use 3G. You may need to replace your device. Read more: https://lnkd.in/g3n5A7-8

The South African Health Products Regulatory Authority (SAHPRA) and the TGA have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health products regulators. The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered. SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns. Read more: https://lnkd.in/gbsKyBxy

Pharmacists play an important role in providing patients with smoking and vaping cessation support, which may include supplying unapproved therapeutic vaping goods. Vapes can be supplied to patients from participating pharmacies in two ways: 1. with a prescription from a medical or nurse practitioner 2. as a pharmacist only medicine. Pharmacists must meet certain regulatory obligations as well as any additional state or territory requirements or restrictions. Visit our website for more information: https://lnkd.in/deHwB7E8

Four concurrent streams over two days as well as our 'Meet the TGA' conversation stations – our jam-packed program for GMP Forum 2024 is finalised and ready for November in Melbourne! Don't miss out! Registrations close on 3 November 👉 https://lnkd.in/g4NzCX8U

Before you advertise therapeutic goods on social media, it’s important to understand and comply with the legislative requirements. Under these rules, advertising prescription-only medicines to the public is prohibited. For therapeutic goods that can be advertised to the public, such as complementary medicines, you must ensure social media posts only promote the safe and responsible use of those products and do not mislead or deceive consumers. Visit our website for more information: https://lnkd.in/gGNU7yaA

The Pharmaceutical Society of Australia (PSA) is holding face-to-face workshops for pharmacists to learn about the regulatory changes relating to sourcing and dispensing of vapes. Registration is open to all AHPRA registered pharmacists. Visit the PSA website to register 👉 https://lnkd.in/ggPcYHT9

The GMP Forum is only 7 weeks away! Join us at the Melbourne Convention and Exhibition Centre on 19-20 November, and speak to our experts on trending topics, TGA inspection trends, and other key reforms underway in GMP Clearance and Recalls. Register now so you don’t miss out 👉 https://lnkd.in/dUAPRJUi

⚠️Safety advisory – Counterfeit Ozempic pens detected and adverse event reported⚠️ Consumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for. We have received one report of a life-threatening adverse event in Australia after a person used a counterfeit pen labelled as Ozempic that contained insulin. This pen was bought overseas. The TGA, in collaboration with the Australian Border Force (ABF), has detected counterfeit Ozempic-labelled pens being imported into Australia. The pens are currently undergoing laboratory testing. However, as the safety, quality and efficacy of these products are unknown, they may pose a serious health risk and should not be used. Counterfeit products may have spelling errors, instruction leaflets not in English, unsealed packaging, changes in medicine size, shape, or appearance. These are indicators that the medicine has not been produced by the original manufacturer or is being illegally sold in the wrong market. The two products subject to this alert both appear to be relabelled insulin pens. The end cap is blue (not grey), the dosage barrel is in a different place, the sticker is not adhering properly to the pen and the rendering of the packaging is poor quality. The batch numbers labelled on the pens - NPSG234 detected by ABF and JS7A925 from the adverse event – have been confirmed as not genuine batch numbers by Novo Nordisk, the manufacturer of Ozempic. Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources. Read more: https://lnkd.in/gSCDP5Rk