Prescribed circumstances under which biologicals may be imported, exported or supplied
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:
the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and
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
a nonconforming biological that is included in the Register under Part 3‑2A of the Act is available; and
no other treatment option is suitable for the patient; and
the nonconforming biological is assessed as the most suitable treatment for the patient; and
the nonconforming biological is to be used only for the treatment of one patient.
This Act’s bill:Explanatory statement
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