Therapeutic Goods Regulations 1990

An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:

ascertaining whether or not the goods are therapeutic goods or vaping goods;

assessing the quality, safety, efficacy or performance of therapeutic goods or vaping goods;

monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;

supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.

If an analyst selects a sample of goods for testing under this regulation, the analyst must:

test the sample or arrange for another analyst to test the sample; or

arrange for the sample to be tested by another appropriate person or body.

An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.

However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:

the sample is not required to be tested under this regulation; and

if testing of the sample has already commenced—the testing may be ceased.

A sample of goods may be tested under this regulation:

regardless of how or where the sample was obtained or accessed by, or given to:

the Department or an analyst; or

another person or body as arranged under paragraph (2)(b); and

whether or not the goods are registered, listed or included in the Register.

To avoid doubt:

more than one test may be conducted on a particular sample of goods; and

more than one analyst or other person or body may test a particular sample of goods; and

a particular sample of goods may be tested at more than one place.

A reference in this regulation to a sample of goods includes a reference to a part of a sample of goods.