Therapeutic Goods Administration

To support the Government’s reforms to the regulation of vaping goods in Australia, transitional arrangements have been put in place. These arrangements allow businesses holding vaping goods that can no longer be supplied in Australia to divest themselves of these products without committing a supply or possession offence. The Business Surrender Scheme allows businesses to surrender specified quantities of vaping goods that were lawful prior to 1 July 2024 but that are no longer lawful following the commencement of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 on 1 July 2024. The scheme is available to businesses possessing more than: • 280 vaping devices • 1,800 vaping accessories • 12,000mL of vaping substance. Businesses that wish to participate must notify the TGA before 1 September 2024 by email to vapereturn@health.gov.au. The scheme is available to pharmacy and non-pharmacy retailers, wholesalers, manufacturers, importers, exporters, transport or storage providers. Read more: https://lnkd.in/gKuMn7nA

📢 Update: the closing date has been extended to 18 August 2024. We’re seeking public comment on potential reforms to Part 5 of the Therapeutic Goods Regulations 1990. The potential reforms are aimed at strengthening and modernising the legislative framework for the examination, testing and analysis of therapeutic goods. Have your say using our online survey 👉 https://lnkd.in/gXPVXtxr

The TGA laboratories perform a range of activities to ensure therapeutic goods are of an acceptable standard. These activities include: • laboratory testing of therapeutic goods • providing scientific expertise to assess technical data for the registration and inclusion of therapeutic goods on the Australian Register of Therapeutic Goods • providing administrative, scientific, and engineering advice to the TGA, expert committees, government, industries and consumers, and so much more. Head to our website to learn about the range of work carried out by the TGA laboratories: https://lnkd.in/gRXF99fm

New AusPAR for Spevigo (spesolimab) has been approved for the treatment of generalised pustular psoriasis, a rare but severe form of psoriasis that involves flares of widespread, non-infectious, macroscopically visible pustules. Read more: https://lnkd.in/g95RKfdV

We have issued 21 infringement notices totalling $319,260 to 4 businesses and 3 individuals for the alleged unlawful advertising of prescription-only medicines, primarily for weight loss, on their websites. The infringement notices were issued to businesses including online telehealth clinics and medical practices offering telehealth services. It is alleged that each business unlawfully: • promoted the use and supply of prescription-only medicines including weight loss and erectile dysfunction medicines such as Ozempic, Saxenda and Viagra • advertised weight loss medicines outside of their approved use (indication) • stated that certain prescription-only medicines were TGA approved • stated that certain therapeutic goods were safe, contravening the Therapeutic Goods Advertising Code. Nick Henderson, acting Deputy Secretary of the Department of Health and Aged Care said, “Advertising prescription-only medicines directly to consumers is prohibited under the Therapeutic Goods Act 1989 (the Act) as it could create an inappropriate demand for these medicines and lead to unnecessary or harmful prescribing. “Appropriate treatment options should be determined by a health professional in consultation with their patient.” Read more: https://lnkd.in/gAmkg9kW

⚠️Medicine shortage update – Zactin Tabs shortage resolved⚠️ The pharmaceutical company, Alphapharm, has notified us that the shortage of Zactin Tabs (fluoxetine 20 mg dispersible tablets) has resolved. Supply has returned to normal. Visit our website for more information: https://lnkd.in/g26yA52f

Registrations are now open for the GMP Forum 2024! You can view the draft program and purchase your tickets through the event website. Registrations for workshops will have limited capacity and will open at a later date. By registering for the main event, you will be notified when the workshop registrations open. To register and get more information, visit our website 👉 https://lnkd.in/giPE9Vyf

We have issued 3 infringement notices totalling $56,340 to News Life Media Pty Ltd for alleged unlawful advertising of medicinal cannabis on their popular lifestyle website Body+Soul. It is alleged that an article published on Body+Soul promoted the use or supply of medicinal cannabis to treat serious diseases or conditions, such as anxiety and chronic pain, in contravention of the Therapeutic Goods Act 1989 (the Act). These references are considered restricted or prohibited representations and are not permitted in advertising for therapeutic goods unless prior approval or permission by the TGA. Nick Henderson, acting Deputy Secretary of the Department of Health and Aged Care said, “Advertising prescription-only medicines, such as medicinal cannabis, directly to consumers is prohibited as it may create inappropriate demand and lead to unnecessary or harmful prescribing. “Treatment options should only be determined by a health professional in consultation with their patient. The TGA reminds businesses that the Act applies to anyone publishing information about therapeutic goods whether they are media outlets or the suppliers of those goods.” Read more: https://lnkd.in/gz_5mjsJ

Our role is to regulate the medicines and medical devices you use in Australia. However, we sometimes get enquiries about services and products we don’t regulate. For example, veterinary medicines, food, cosmetics and healthcare professionals. Find out more about what we don’t regulate on our website: https://lnkd.in/gzpQvdxJ

As of 15 June 2024, changes have come into effect regarding the regulation of: • software-based medical devices • prescription spectacle lenses. As of 1 July 2024, changes have come into effect regarding the regulation of: • medical devices containing microbial, recombinant, or animal substances • medical device application audit requirements. For more information and guidance around these changes, visit our website: https://lnkd.in/gbtKChq5