Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
7. Exemptions7. Exemptions
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7. Exemptions
The requirements of this Order do not apply to the following:
(1) fresh viable human organs, or parts of human organs and associated cells and tissue for direct donor to host transplantation;
(2) biopsied cell or tissue samples taken for in vitro diagnosis and that are not for manufacture and/or reintroduction or transplant to a recipient;
(3) human blood, blood components and haematopoietic progenitor cells that are:
(a) collected by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, in the course of medical treatment and for the purposes of diagnosis of, and testing for, a medical condition; or
(b) manufactured by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, for therapeutic application to a particular patient under the practitioner’s care; or
(c) manufactured by a blood donation centre for a medical practitioner who is registered under a law of a State or Territory, for therapeutic application to a particular patient under the practitioner’s care.