Articles

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.

Essential principle 7 now mentions nanomaterials explicitly (see EP 7.7)

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

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

JSHealth Vitamins Pty Ltd fined for alleged unlawful advertising

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 new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022

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.

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

A new S41BD(3) instrument has been signed to declare that some nappy rash products are not to be medical devices for the purposes of the Act

Therapeutic Goods (Declared Goods) Order 2019 consolidates and replaces several instruments

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

This instrument applies to an application to list a complementary medicine under section 26AE of the Act.

This instrument applies to an application to list a medicine under section 26 or 26A of the Act.

This instrument applies to an application to register a complementary medicine

This instrument applies to the online form titled Prescription Medicines Designation/Determination Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form

s23 instruments supporting the new COR process have been updated.

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.

Repeals 48 former notices made between 2005 and 2015 that are no longer required