Document ID: chunk:federal_register_of_legislation:F2024C00464:reg:7
Version: federal_register_of_legislation:F2024C00464
Segment Type: reg
Provision Reference: reg 7
Character Range: 8643–10138

7  Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs
  The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:
 (a) biologicals that do not comprise or contain:
 (i) live animal cells; or
 (ii) live animal tissues; or
 (iii) live animal organs;
 (b) blood;
 (c) blood components;
 (d) haematopoietic progenitor cells.
Note 1:  The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).
Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.

Part 3 – Application

8 Application
 (1) The amendment of this instrument made by item 1 in Schedule 1 to the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2024 applies in relation to therapeutic goods manufactured on or after 3 June 2024.
 (2) Despite subsection (1), the amendment of this instrument made by item 1 in Schedule 1 to the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2024, only to the extent that the amendment has the effect of incorporating Annex 16 of the PIC/S Guide to GMP, applies to therapeutic goods manufactured on or after 3 September 2024.