Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16gf
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16GF
Character Range: 244623–245575

16GF  Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act
 (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:
 (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;
 (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.
 (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.

Division 4—Complementary medicines and certain other listed medicines