Therapeutic Goods Regulations 1990

For subsection 15AB(1) of the Act, the conditions are that:

all the circumstances mentioned in regulation 33A have occurred; and

the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:

the proposal to use the nonconforming biological;

that the patient or guardian has been told about the likely risks and benefits from the use of the biological;

why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and

the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and

before the biological is used:

the patient or the patient’s guardian must give written informed consent; or

the treating medical practitioner must give written statement of the reasons that consent cannot be given; and

the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.

Within 28 days after the release of the nonconforming biological, the sponsor must give to the Secretary:

a notification of use of the nonconforming biological, on a form approved by the Secretary; and

a copy of the documents mentioned in paragraphs (1)(b) to (d); and

any other information requested by the Secretary, including any information requested after submission of the notification.

The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.