Therapeutic Goods Regulations 1990

an officer of the Department, of another Department or of an authority of the Commonwealth;

an officer of:

a Department of State of a State; or

a Department or administrative unit of the Public Service of a Territory; or

an authority of a State or of a Territory;

In this regulation:

the Therapeutic Goods Regulations 1990; and

the Therapeutic Goods (Medical Devices) Regulations 2002.

For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:

the Poisons and Therapeutic Goods Act 1966 (NSW);

the Poisons and Therapeutic Goods Regulation 2008 (NSW);

the Therapeutic Goods (Victoria) Act 2010 (Vic);

the Therapeutic Goods Act 2019 (Qld);

the Therapeutic Goods Regulation 2021 (Qld);

the Therapeutic Goods Law Application Act 2024 (WA);

the Controlled Substances Act 1984 (SA);

the Controlled Substances (Poisons) Regulations 2011 (SA);

the Therapeutic Goods Act 2001 (Tas);

the Therapeutic Goods Regulations 2002 (Tas);

Medicines, Poisons and Therapeutic Goods Act 2008 (ACT);

Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT);

Medicines, Poisons and Therapeutic Goods Act 2012 (NT);

Medicines, Poisons and Therapeutic Goods Regulations 2014 (NT).

a product of a kind mentioned in Part 1 of Schedule 10; or

a medicine that satisfies the following requirements:

the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;

the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);

the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii); or

a medicine that satisfies the following requirements:

the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act;

if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or

a medicine that satisfies the following requirements:

the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act;

if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.

For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.

For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.

This regulation applies to goods that comprise, contain, or are derived from human cells or tissues.

The human cells or tissues are the original cells or tissues.

The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.

Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.

Class 1 biological;

Class 2 biological;

Class 3 biological;

Class 4 biological;

export only biological.

This Part applies to advertisements to which Part 5‑1 of the Act applies.

For subsection 42AA(2) of the Act, the bodies mentioned in Schedule 1 are prescribed.

See section 42B of the Act for definitions of terms used in Part 5‑1 of the Act.

Advisory Committee on Medicines;

Advisory Committee on Complementary Medicines;

Advisory Committee on Medical Devices;

Advisory Committee on Vaccines.

For the purposes of subsection 42DJ(1) of the Act:

the representations in column 2 of an item in the table in Part 1 of Schedule 2 are specified; and

the therapeutic goods in column 3 of that item are specified.

Under subsection 42DJ(1) of the Act, those representations about those goods are prohibited representations.

For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.

therapeutic goods that are the subject of an approval or authority under section 19 of the Act;

a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;

medicines covered by an exemption under subregulation 12A(1);

therapeutic goods specified in item 1 or 6 of Schedule 5;

therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A;

a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);

a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;

therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act.