Document ID: chunk:federal_register_of_legislation:F2023L00531:clause:1_4
Version: federal_register_of_legislation:F2023L00531
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 1579–2742

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) biological;
(b) medicine;
(c) Secretary;
(d) sponsor.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
adverse event means an adverse event that occurs in relation to a person in Australia following the administration of a medicine or biological.
Note: An adverse event may not necessarily have a causal relationship with the administration of the medicine or biological.
AEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration.
product name, for a medicine or biological, means either:
 (a) the commercial name:
 (i) given to the medicine or biological by the sponsor or manufacturer; and
 (ii) under which the medicine or biological is supplied; or
 (b) the name recorded in the AEMS for the medicine or biological by the Therapeutic Goods Administration.
Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.