7

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.