Document ID: chunk:federal_register_of_legislation:F2025L00267:clause:2_4:p1
Version: federal_register_of_legislation:F2025L00267
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 2292–5066

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 number;
(b) device number;
(c) health practitioner;
(d) included in the Register;
(e) indications;
(f) listed goods;
(g) listing number;
(h) Register;
(i) registered goods;
(j) registration number;
(k) Secretary;
(l) therapeutic goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
action commencement date means the date the market action to be implemented by the responsible entity was agreed to by the TGA.
action level means the level of market action to be implemented by the responsible entity, based on the persons or bodies, or classes of persons or bodies, that are affected, or likely to be affected, by the market action.
Note: The TGA determines the action level as one of the following:
(a) Wholesale level;
(b) Hospital level;
(c) Retail level;
(d) Consumer level.
active ingredient has the same meaning as in the TG Regulations.
hazard classification means the classification of the market action determined by the TGA, based on the seriousness of the harm that may be caused by the therapeutic goods to which the market action relates, and the likelihood of that harm occurring.
Note: The TGA classifies market actions as one of the following:
(a) Class I – Critical safety-related;
(b) Class II – Urgent safety-related;
(c) Class III – Lowest risk.
instructions for users means instructions or advice to be given by the responsible entity to health practitioners and other persons affected, or likely to be affected, as part of the market action.
market action, in relation to therapeutic goods supplied in Australia, means one or more of the following measures taken, being taken or to be taken by the responsible entity to address a problem or concern relating to the quality, safety, efficacy or performance, presentation or use of the goods:
 (a) recall or destruction of all or some of the goods;
 (b) notification to the public or particular persons, or classes of persons, of the problem or concern, and provision of advice for risk or harm mitigation;
 (c) rectification of a problem with the goods, including by (but not limited to) repairing, modifying, adjusting or relabelling the goods.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
responsible entity, in relation to therapeutic goods, means:
 (a) if the goods are registered goods, listed goods or included in the Register—the person in relation to whom the goods are registered, listed or included in the Register; or
 (b) if the goods are not registered goods, listed goods or included in the Register—the supplier of the goods in Australia.
TGA means the part of the Department known as