Document ID: chunk:federal_register_of_legislation:F2023L01291:clause:1_1
Version: federal_register_of_legislation:F2023L01291
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 6824–7615

1         information about an adverse event in relation to a medicine or biological that has been reported to the TGA and is recorded in the DAEN – Medicines (medicine adverse event report), as follows:
             (a) details of the medicine or biological;
             (b) details of any other therapeutic good administered to the person who is reported to have suffered the adverse event (the relevant person);
             (c) the age of the relevant person;
             (d) the gender of the relevant person;
             (e) the adverse event description term, as described in the MedDRA, that relates to the adverse event;
             (f) the date that the adverse event was recorded by the TGA;
             (g) the unique number allocated to the adverse event report by the TGA