Document ID: chunk:federal_register_of_legislation:F2023L00336:clause:2_4:p1
Version: federal_register_of_legislation:F2023L00336
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 1673–4558

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) device number;
(b) health practitioner;
(c) listing number;
(d) Register;
(e) registration number;
(f) Secretary;
(g) therapeutic goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
class of recall action means the classification of the recall determined by the TGA, based on the seriousness of the problem with the therapeutic goods being recalled and the degree of the safety risk.
Note: The TGA classifies recall actions as one of the following:
(a) Class I – Most serious safety-related;
(b) Class II – Urgent safety-related;
(c) Class III – Lowest risk.
level of recall action means the level of recall determined by the TGA, which reflects the extent of supply of the therapeutic goods that are the subject of recall action and the persons or bodies notified, or required to be notified, of the recall action.
Note: The TGA determines the level of recall action as one of the following:
(a) Wholesale level;
(b) Hospital level;
(c) Retail level;
(d) Consumer level.
recall action means one or more of the following four actions taken by the responsible entity to resolve a problem with therapeutic goods supplied in Australia that have, or potentially have, deficiencies relating to safety, quality, efficacy or performance, or the presentation of the goods:
 (a) Recall— permanently removing the goods from the market;
 (b) Product Defect Correction—taking corrective action in relation to the goods, such as repairing, modifying, adjusting or relabelling the goods, which may take place at the user's premises, the responsible entity's premises or any other agreed location;
 (c) Product Defect Alert—raising awareness about the problem with the goods and describing the actions that health practitioners or patients may take to mitigate risks due to that problem;
 (d) Hazard Alert—where the goods have been implanted into patients, providing precautionary information to health practitioners and their patients about the identified deficiencies and how to manage affected patients.
recall commencement date means the date the recall action to be undertaken by the responsible entity was agreed to by the TGA.
recall instructions means instructions or advice given by the responsible entity to all persons impacted, or likely to be impacted, by the recall action.
Regulations means the Therapeutic Goods Regulations 1990.
responsible entity means:
 (a) where therapeutic goods are included in the Register—the person in relation to whom the goods are included in the Register; or
 (b) where therapeutic goods are not included in the Register—the supplier of the goods in Australia.
TGA recall reference means the unique identification number that the TGA