Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16ga
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16GA
Character Range: 241178–242566

16GA  Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 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 concerning the following substances:
 (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;
 (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.
 (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.

Exemption from fee
 (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.

Division 3—Class 2, Class 3 and Class 4 biologicals