4Definitions

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) health practitioner;

(c) included in the Register;

(d) Register;

(e) sponsor;

(f) supply.

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 biological.

Note: An adverse event may not necessarily have a causal relationship with the administration or use of the biological.

Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.