Document ID: chunk:federal_register_of_legislation:F2018L01155:reg:5
Version: federal_register_of_legislation:F2018L01155
Segment Type: reg
Provision Reference: reg 5
Character Range: 1484–2069

5  Kind of information
  For the purposes of subsection 23B(9) of the Act, the application must be accompanied by:
 (a) the information required by the document titled CTD Module 1: Administrative information for assessed listed medicines, version 1, published by the TGA in March 2018; and
 (b) the information required by the document titled Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, version 1, published by the TGA in March 2018.
Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).