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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 is the new the legislative instrument, Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2021 to be published on the TGA website. It is for the Six monthly report – supply of unapproved therapeutic goods by a sponsor.

Legislative instrument made under 47B Provision of information concerning medicines, biologicals and medical devices.

The TGA has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp) in relation to its COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).

Introduction of requirements for sponsors of sartan medicines

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

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.

Information about the Senate inquiry into the ‘Number of women in Australia who have had transvaginal mesh implants and related matters.’

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 Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.

This instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.

Direction Notice issued to cease advertising of therapeutic goods not entered in the ARTG

New legislative instrument

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

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

Mr Leyonhjelm was directed to cease advertising a prescription medicine for the treatment of Covid-19.

The Therapeutic Goods (Permissible Indications) Determination has been updated

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

An independent review of the impact of the reforms to the therapeutic goods advertising framework has commenced.

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 41FDB, 41FF and 41FH of the Act