Legislation

This Specification facilitates the public release of specified therapeutic goods information.

This amendment to the Therapeutic Goods Regulations 1990 makes various changes to support the implementation of the TGA’s Medicines Repurposing Program (MRP), and a small number of other measures.

This Instrument amends the Therapeutic Goods Regulations 1990 to increase fees relating to therapeutic goods to support cost recovery.

To read the full text, visit the Federal Register of Legislation.

These Amendment Regulations amend the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Medical Devices) Regulations 2002 to implement the first stage of the Government's vaping reform measures.

This Therapeutic Goods Order determines various publications which constitute standards for medicine manufactured in Australia, or imported into Australia, for export only.

This Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of prescription and other related medicines.

This Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.

This Therapeutic Goods Order constitutes a standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.

This Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.

These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods.

To read the full text, visit the Federal Register of Legislation.