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📢 Calling content creators and health, wellness and beauty influencers 📢Promote better health without breaking the rules...
05/07/2025

📢 Calling content creators and health, wellness and beauty influencers 📢
Promote better health without breaking the rules.
The rules for promoting therapeutic goods like medicines and vitamins are stricter than for most other products like cosmetics.
Did you know that:
• you can’t advertise prescription medicines
• you can't make paid testimonials
• hashtags form part of an advertisement
• you can’t advertise therapeutic goods that aren’t entered on the ARTG?

⚠️Medicine shortage update – Substitutions approved for shortage of metformin immediate-release tablets⚠️Various brands ...
05/07/2025

⚠️Medicine shortage update – Substitutions approved for shortage of metformin immediate-release tablets⚠️
Various brands of metformin hydrochloride 1000 mg immediate-release tablets are in shortage.
To help manage this shortage, we have made a Serious Scarcity Substitution Instrument (SSSI) that allows a pharmacist to dispense an alternative brand, formulation or strength, if appropriate, without a new prescription from the prescriber.
The SSSI starts on 28 May 2025.

⚠️Medicine shortage update - new presentation of Ozempic (semaglutide) 0.25 mg/0.5 mg pre-filled pens⚠️Novo Nordisk has ...
05/07/2025

⚠️Medicine shortage update - new presentation of Ozempic (semaglutide) 0.25 mg/0.5 mg pre-filled pens⚠️
Novo Nordisk has advised us that a new 3 mL presentation of Ozempic (semaglutide) 0.25 mg/0.5 mg pre-filled pen is now available, as of June 2025. This will gradually replace the 1.5 mL presentation of Ozempic 0.25 mg/0.5 mg pre-filled pen, which will be discontinued as of 1 December 2025.
Both pre-filled pens presentations deliver the same semaglutide dosage(s) (either 0.25 mg or 0.5 mg per dose).
Please note that the introduction of the new 3 mL presentation will not affect the shortage status of Ozempic products, which will all continue to have limited availability throughout 2025.

⚠️Medicine shortage update - Discontinuation of Mounjaro (tirzepatide) vials⚠️Pharmaceutical company Eli Lilly has infor...
05/07/2025

⚠️Medicine shortage update - Discontinuation of Mounjaro (tirzepatide) vials⚠️
Pharmaceutical company Eli Lilly has informed us that all strengths of Mounjaro (tirzepatide) vials are now discontinued due to commercial reasons and supply of all vial presentations has been exhausted.
This discontinuation only affects the vial presentation.
Mounjaro KwikPen is available and there are no reported supply issues with any strength of Mounjaro KwikPen at present.
Mounjaro KwikPens cannot be dispensed using a prescription for the vial presentation, so patients requiring the KwikPen will need a new prescription.
The KwikPen presentation is a multi-dose, pre-filled pen containing the same dosage amounts as the pre-existing Mounjaro vials (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg). The KwikPen is also approved for the treatment of type 2 diabetes and chronic weight management.

05/07/2025

Counterfeit medicines can be hard to identify.
The quickest way to find out if you’ve bought a fake medicine is by comparing it with an authentic one.
Look for differences in:
• size, weight, colour, quality or embossing
• packaging
• spelling errors in the medicine name.

From 1 July 2025, strengthened standards will come into effect for all therapeutic va**ng products for smoking cessation...
05/07/2025

From 1 July 2025, strengthened standards will come into effect for all therapeutic va**ng products for smoking cessation and ni****ne dependence.
Participating pharmacies can only supply v**es that meet the TGA’s strengthened product standards, subject to state and territory laws, and where clinically appropriate.
These measures are designed to mitigate certain risks associated with therapeutic v**e use by enforcing stronger safety and quality standards, including stricter requirements for ingredients, packaging, and labelling.
The implementation of stricter product standards may lead some sponsors to withdraw certain va**ng products from the market. A range of therapeutic va**ng products, including substances, devices, kits, and accessories, will still be available where they have been notified by sponsors as complying with the strengthened TGA product standards.
If the therapeutic va**ng product you are using is no longer available, consult your pharmacist or prescriber for alternative options.

We have accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to...
05/07/2025

We have accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.
Between 1 May 2023 to 17 November 2024, Aussie Gelatin manufactured, supplied and advertised its product, Nutraviva Bone and Joint Formula, in contravention of the Therapeutic Goods Act 1989 (the Act). The product was not entered in the Australian Register of Therapeutic Goods (ARTG) and contained a prescription-only strength of Vitamin D3 (colecalciferol).
Vitamin D is regulated as a prescription-only medicine when included in preparations containing over 25 micrograms of Vitamin D per recommended daily dose.
In Australia, therapeutic goods must be entered in the ARTG before they can be lawfully manufactured, supplied, or advertised, unless a specific exemption applies. This requirement serves as a critical safeguard to ensure that therapeutic goods available to consumers are safe and high quality, and that they work as intended.

From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit t...
05/07/2025

From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit the import, manufacture and use of three PFAS chemicals in Australia:
• PFOS (perfluorooctane sulfonate)
• PFOA (perfluorooctanoic acid)
• PFHxS (perfluorohexane sulfonate)
IChEMS does not apply to chemicals used for therapeutic purposes. This means medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the ban.

The TGA is consulting on an interim decision to reduce the maximum amount of vitamin B6 permitted in products available ...
05/07/2025

The TGA is consulting on an interim decision to reduce the maximum amount of vitamin B6 permitted in products available for general retail sale to 50 mg per recommended daily dose.
Products containing greater than 50 mg but less than 200 mg of vitamin B6 would become Pharmacist Only medicines (Schedule 3), under the proposal. There would be no change to products containing more than 200 mg, which would remain as Prescription Only medicines (Schedule 4).
The interim decision follows an application to amend the Poisons Standard and a subsequent discussion by the Advisory Committee on Medicines Scheduling (ACMS) in November 2024.
The interim decision balances the risks and benefits of using vitamin B6. There is limited clinical need for dietary supplementation, while the potential risks include peripheral neuropathy, which may cause irreversible adverse effects. Given the widespread use of vitamin B6 in fortified products and listed medicines and difficulties in calculating total daily intake from multiple sources of vitamin B6, this interim decision seeks to reduce the potential harms.
Consumers are reminded that just because a medicine is available without a prescription, or claims to be ‘natural’ or ‘healthy’, doesn’t mean it’s safe for you. Speak to your healthcare provider if you have any concerns about your vitamin B6 intake.

The TGA is aware that recent media reports have stated that the TGA estimates that more than 10 million v**es are sold n...
05/07/2025

The TGA is aware that recent media reports have stated that the TGA estimates that more than 10 million v**es are sold nationally every month on the black market. These reports are incorrect.
The information on 10 million v**es came from a document provided to the TGA by a third party during consultation and was released by the TGA as part of a Freedom of Information request.
The TGA does not hold information on the number of illicit v**es sold in Australia, and reports that suggest otherwise are inaccurate. The Australian Government has recently provided funding to the TGA to undertake work to collect a range of data to better understand the lawful supply of therapeutic va**ng goods in Australia. This work is underway.
Therapeutic va**ng goods for smoking cessation or the management of ni****ne dependence are only available for sale from participating pharmacies, where clinically appropriate. It is illegal for all other retailers, such as tobacconists, v**e shops and convenience stores, to sell any kind of v**e, regardless of whether it contains ni****ne.

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