Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9_1:p3
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9 cl 1 (pt 3/3)
Character Range: 648508–650444

differs from the registered substance in having different safety or efficacy properties; or
 (c) a biological substance that, having previously been included in the Register, differs from the registered substance:
 (i) in having a different molecular structure; or
 (ii) in deriving from source material of a different nature or from a different manufacturing process; or
 (d) a radiopharmaceutical substance that:
 (i) is a radionucleide or ligand that has not previously been included in the Register; or
 (ii) has a coupling mechanism, linking the molecule and radionucleide, that has not previously been included in the Register; or
 (e) a fixed combination of active substances that have not previously been included in the Register as that fixed combination.
page means:
 (a) a legible photocopy of 1 side of 1 leaf of a published work, diagram or chart; or
 (b) in respect of any other work—1 side of 1 leaf (or a copy of 1 side of 1 leaf):
 (i) that has a maximum length of 297 millimetres and a maximum width of 210 millimetres; and
 (ii) that has a left‑hand margin that is at least 25 millimetres in width; and
 (iii) the information on which is typed or printed in legible characters at least 8 points in size; and
 (iv) that, if it is part of a document exceeding 1 page in length—is paginated.
primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured.
 (2) For paragraph (a) of item 2A and items 2B, 2C, 2CA and 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 is taken to be a submission.
 (3) A person making more than 1 application of a kind mentioned in subclause (2), simultaneously, is taken to be making a submission that includes all of those applications if the goods concerned contain the same active ingredient.