Document ID: chunk:federal_register_of_legislation:F2023L01291:clause:1_2
Version: federal_register_of_legislation:F2023L01291
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 7615–8404

2         information collated by the TGA from reports of adverse events received by the TGA in relation to a medicine or biological and recorded in the DAEN – Medicines (relevant cases), as follows:
             (a) the number of relevant cases;
             (b) the number of relevant cases where death was a reported outcome;
             (c) the number of relevant cases in which the medicine or biological was reported to be the only therapeutic good suspected of being related to the adverse event;
             (d) the system organ class terminology, as described in the MedDRA, for the part of the body that was reported as being affected by each adverse event;
             (e) the adverse event description term, as described in the MedDRA, that relates to each adverse event