Document ID: chunk:federal_register_of_legislation:F2024C00464:schedule:1:p2
Version: federal_register_of_legislation:F2024C00464
Segment Type: schedule
Provision Reference: sch 1 (pt 2/4)
Character Range: 12787–15636

the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.
 (3) An application for a licence to carry out steps in the manufacture of blood, blood components or haematopoietic progenitor cells must include a technical master file in relation to those goods (the relevant technical master file).
 (4) Blood, blood components and haematopoietic progenitor cells must be manufactured in a manner consistent with the relevant technical master file.
 (5) A blood processing plant that processes plasma collected from donors in Australia for products that are, or will be, used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:
 (a) a plasma master file prepared in accordance with the requirements of the PMF Guideline has been submitted to a relevant officer by the licence holder of the blood processing plant; and
 (b) a relevant officer has advised the licence holder of the plant that, based on the plasma master file submitted for those goods, and having taken into account the processes of the plant, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.
 (6) The failure of a manufacturer of therapeutic goods to which this Part applies, to follow an applicable procedure or requirement set out in the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless, in relation to that particular procedure or requirement:
 (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:
 (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
 (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and
 (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or
 (b) where an alternative to the procedure or requirement set out in the Australian Code of Good Manufacturing Practice has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:
 (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
 (ii) the alternative will not increase the risk of those