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Therapeutic Goods Act 1989

Submitted by Richard_Li on
Distinguished Terms in this instrument
Term(s) Definition Defined in Legislation See Section(s)
premises

includes:

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
presentation

, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
primary pack

, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
product information

, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
prohibited representation

means a representation referred to in subsection 42DJ(1).

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 42B Definitions
Therapeutic Goods Act 1989 - 42DJ Prohibited and required representations
protected information

, in relation to therapeutic goods, has the meaning given by section 25A.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
Therapeutic Goods Act 1989 - 25A When the Secretary must not use protected information
quality

, in relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
refurbishment

has the meaning given by the regulations.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
Register

means the Australian Register of Therapeutic Goods maintained under section 9A.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 9A Australian Register of Therapeutic Goods
Therapeutic Goods Act 1989 - 3 Interpretation
registered charity

means an entity that is registered under the Australian Charities and Not ‐ for ‐ profits Commission Act 2012 as the type of entity mentioned in column 1 of item 1 of the table in subsection 25 ‐ 5(5) of that Act.

Therapeutic Goods Act 1989
registered goods

means:

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
registration number

, in relation to registered goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
Therapeutic Goods Act 1989 - 27 Registration or listing number
related body corporate

, in relation to a body corporate, means a body corporate that is related to the first ‐ mentioned body by virtue of section 50.

Corporations Act 2001
reportable medicine

has the meaning given by section 30EH.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
Therapeutic Goods Act 1989 - 30EH What is a reportable medicine?
required representation

means a representation referred to in subsection 42DJ(2).

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 42B Definitions
Therapeutic Goods Act 1989 - 42DJ Prohibited and required representations
restricted information

has the meaning given by section 26AF.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
Therapeutic Goods Act 1989 - 26AF When the Secretary must not use restricted information in evaluating medicine for listing under section 26AE
restricted medicine

means:

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation
restricted representation

means a representation referred to in section 42DD .

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 42B Definitions
Therapeutic Goods Act 1989 - 42DD Restricted representations
scheduling

has the meaning given by section 52A.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 52A Definitions
Therapeutic Goods Act 1989 - 3 Interpretation
Secretary

means the Secretary of the Department.

Therapeutic Goods Act 1989 Therapeutic Goods Act 1989 - 3 Interpretation

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