Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018
6Kind of information
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6 Kind of information
For the purposes of subsection 32DDA(9) of the Act, an application relating to a Class 2,3 or 4 biological must be accompanied by the information required by the Technical Requirements section of the document titled Dossier requirements for Class 2, 3 and 4 biologicals, Australian Regulatory Guidelines for Biologicals (ARGB) version 1.0, published by the TGA in July 2018.
Note: The document mentioned in section 6 is available on the TGA website (www.tga.gov.au).