Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:33a
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 33A
Character Range: 308659–309621

33A  Prescribed circumstances under which biologicals may be imported, exported or supplied
  For paragraphs 14(5A)(b), (9A)(b), (13A)(b), 14A(1A)(b), (2A)(b) and (3A)(b) of the Act, the circumstances are:
 (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and
 (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and
 (c) a nonconforming biological that is included in the Register under Part 3‑2A of the Act is available; and
 (d) no other treatment option is suitable for the patient; and
 (e) the nonconforming biological is assessed as the most suitable treatment for the patient; and
 (f) the nonconforming biological is to be used only for the treatment of one patient.