Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination 2018 (Cth)
Therapeutic Goods (Biologicals—Information that Must Accompany Application for Inclusion in Register) Determination 2018
I, Larry Kelly, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 32DDA of the Therapeutic Goods Act 1989, make the following Determination under subsections 32DDA(9) and (10) of that Act.
Dated 17th May 2018
(Signed by)
LARRY KELLY
Delegate of the Secretary of the Department of Health
1 Name
This instrument is the Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination 2018.
2 Commencement
This instrument commences on the day after it is registered.
3 Definitions
In this instrument:
Act means the Therapeutic Goods Act 1989.
Class 2 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 3 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
Class 4 biological has the meaning given by regulation 2 of the Therapeutic Goods Regulations 1990.
TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
4 Applications to which this instrument applies
This instrument applies to an application under section 32DD of the Act to include a Class 2 biological, Class 3 biological or Class 4 biological in the Australian Register of Therapeutic Goods.
5 Kind of information
For the purposes of subsection 32DDA(9) of the Act, the application must be accompanied by the following information:
(a) for an application relating to a Class 2 biological—the information required by the Technical Requirements section of the document titled Australian Regulatory Guidelines for Biologicals, Appendix 1 – Guidelines on Class 2 Biological dossier requirements, version 1.1, published by the TGA in March 2018;
(b) for an application relating to a Class 3 biological—the information required by the Technical Requirements section of the document titled Australian Regulatory Guidelines for Biologicals Appendix 2 – Guidelines on Class 3 Biological dossier requirements, version 1.1, published by the TGA in March 2018;
(c) for an application relating to a Class 4 biological—the information required by the Technical Requirements section of the document titled Australian Regulatory Guidelines for Biologicals Appendix 3 – Guidelines on Class 4 Biological dossier requirements, version 1.1, published by the TGA in March 2018.
Note: The documents mentioned in section 5 are available on the TGA website ( Form of information
For the purposes of subsection 32DDA (10) of the Act, the information must be:
(a) contained in an application dossier; and
(b) in a form consistent with the document titled General dossier requirements, version 1.3, published by the TGA in March 2018.
Note: The document mentioned in paragraph 6(b) is available on the TGA website (
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