Articles

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

Following a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions.

This instrument is made under section 39 of the current Poisons Standard.

On 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA

The TGA are updating the Therapeutic Goods (Declared Goods) Order 2019 (Declared Goods Order) on 1 March 2023. This is the first time since 2020 that the Declared Goods Order has been amended to capture an update to WADA’s World Anti-Doping Code International Standard Prohibited List (Prohibited List).

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

The TGA has issued a direction notice to a Melbourne-based individual to cease advertising of all nicotine vaping products.

The TGA has today published an interim decision to reduce the maximum pack sizes for various paracetamol products.

From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

The TGA has issued infringement notices to Caveman Nutrition Pty Ltd, The Cave Nutrition Store Pty Ltd and to the director of these companies for the alleged unlawful advertising of sports supplements and therapeutic goods not included in the ARTG.

The TGA has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for supplying a complementary medicine that allegedly did not conform with legal requirements.

The TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants.

This instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.

The TGA has issued infringement notices to Mode Medical Pty Ltd for the alleged unlawful advertising to Australian consumers on a company website and social media.

This is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine.

The TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.

Travellers will be able to bring up to 3-months supply of their medicine.

Approval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations)

The TGA is seeking public comment on potential reforms to the regulation of nicotine vaping products in Australia.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.

The TGA has issued an infringement notice of $2,664 to a NSW-based medical practitioner for alleged unlawful advertising of nicotine vaping products in a social media post.

The TGA has granted a provisional determination to Pfizer's bivalent COVID-19 vaccine candidate: tozinameran & famtozinameran (COMIRNATY BIVALENT OMICRON BA.4/BA.5 COVID-19 VACCINE).

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act

On 25 October 2022, Natural Franchises Pty Ltd pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods.

The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are affected by the recall action.