Articles

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

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

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

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Riltozinameran) Labelling Exemption 2022.

The TGA has issued a direction notice to MDNE Enterprises Pty Ltd to cease promoting the use and supply of nicotine vaping products to the Australian public.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.

The TGA has provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over.

Section 7 declarations provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.

The TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.

Update to the manufacturing principles for medicinal products

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

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

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 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.

This labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.

The TGA has issued a direction notice to Phenix Health Pty Ltd to cease alleged unlawful advertising of nicotine vaping products.

Direction Notice issued to cease advertisement of prescription and illegal products

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1991.

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 12 to 15 years old.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

Prevention notice under section 42DKB of the Therapeutic Goods Act 1989.