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
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(1) Human blood and blood components, human tissues and human cellular therapy products that are collected from a donor, or that are subjected to any other manufacture, on or after 31 May 2014 must comply with all relevant requirements of this Order from 31 May 2014.
(2) Human blood and blood components, human tissues and human cellular therapy products that are both:
(i) collected from a donor or subjected to any other manufacture; and
(ii) released for supply;
before 31 May 2014 (including before 31 May 2013), will be exempt from the requirements of this Order.
Note 1: Nothing in (2) is intended to prevent a person from complying with this Order in relation to human blood or a human blood component or human tissues or a human cellular therapy product to which (2) applies before the date of compliance, if they wish to do so.
Note 2: However, if a person elects to do so, that collection or other manufacture must also comply with the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (2013), unless the goods or the manufacturer of those goods are exempt from the operation of Part 3-3 of the Act under either of Schedule 7 or Schedule 8 to the Therapeutic Goods Regulation 1990 (the Regulations).
Note 3: Alternatively, a person may, in relation to human blood or a human blood component or human tissues or a human cellular therapy product to which (2) applies, comply with the Australian Code of Good Manufacturing Practice for blood and tissues (August 2000) in relation to such goods before the 31 May 2014 (i.e. rather than complying with both this Order and the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (2013), unless the goods or the manufacturer of those goods are exempt from the operation of Part 3-3 of the Act under either of Schedule 7 or Schedule 8 of the Regulations.
(3) Human blood and blood components, human tissues and human cellular therapy products that are collected from a donor before 31 May 2014 (including before 31 May 2013), and that are released for supply on or after 31 May 2014, must comply with the testing requirements set out in subsections 11(3), 11(4) and 11(5) of this Order.
(4) Subsection 3(3) does not apply where the sponsor or manufacturer of human blood or a human blood component or human tissues or a human cellular therapy product determines, based on a risk analysis, that it is not possible to comply with the testing requirements mentioned in subsection (3), and where the TGA has agreed to that approach.