Document ID: chunk:federal_register_of_legislation:F2023L00531:clause:1_2
Version: federal_register_of_legislation:F2023L00531
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 5014–6017

2                                                   de-identified information contained in an adverse event report in relation to a medicine or biological that is recorded in the AEMS, where the adverse event report:                                                                      a sponsor (and persons authorised to act on behalf of a sponsor) of a medicine or biological that contains the relevant active ingredient  to assist the sponsor in satisfying pharmacovigilance obligations under the Act, by facilitating access to, and effective analysis of, data relating to safety issues associated with a medicine or biological that contains the relevant active ingredient, in order to ensure the safe use of those goods
                                                      (a) includes the active ingredient of the medicine or biological (the relevant active ingredient); and
                                                      (b) does not include the product name of the medicine or biological