Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 33A

    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.