Document ID: chunk:federal_register_of_legislation:F2019L01493:clause:1_4
Version: federal_register_of_legislation:F2019L01493
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 1718–2982

4  Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) label;
(b) listing number;
(c) manufacture;
(d) medicine;
(e) Register; and
(f) Secretary.

  In this instrument:
Act means the Therapeutic Goods Act 1989.
compliance review, in relation to a listed medicine, means a post-market review carried out by the Therapeutic Goods Administration for the purpose of determining whether certain requirements of the Act, applicable to the medicine, have been, or are being, complied with.
Note:  For example, a compliance review may include verifying the certification made by a relevant sponsor under section 26A or 26AB of the Act in relation to the relevant medicine.
listed medicine means a medicine that is included in the Part of the Register for goods known as listed goods.
Regulations means the Therapeutic Goods Regulations 1990.
relevant medicine means the listed medicine that is the subject of a compliance review.
relevant sponsor means the person in whose name the relevant medicine is listed in the Register.
Therapeutic Goods Administration has the same meaning as in the Regulations.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.