Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_13
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 13
Character Range: 581276–582623

13        Therapeutic goods in relation to which all of the following paragraphs apply:                                                                                                                                                                                                                                                                                                           if the sponsor knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB
          (a) the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;
          (b) the goods were manufactured by, or under the professional supervision of, the practitioner;
          (c) the single indication of the goods is homologous use:
          (i) on that patient; and
          (ii) in a single clinical procedure; and
          (iii) by, or under the professional supervision of, that practitioner;
          (d) the goods have been subjected to only minimal manipulation;
          (e) the practitioner is registered in a State or internal Territory