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Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018.
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 1.4, published by the TGA in July 2018.
Note: The document mentioned in paragraph 7(b) is available on the TGA website (www.tga.gov.au).
Schedule 1—Repeals
Therapeutic Goods (Biologicals–Information that Must Accompany Application for Inclusion in Register) Determination 2018
1 The whole of the instrument
Repeal the instrument.