Document ID: chunk:federal_register_of_legislation:F2022L00758:clause:1_6
Version: federal_register_of_legislation:F2022L00758
Segment Type: clause
Provision Reference: sch 1 cl 6
Character Range: 4955–5826

6  Kind of information
  For the purposes of subparagraph 23B(2)(d)(i) of the Act, an application for the registration of a medicine mentioned in Schedule 1 must be accompanied by information of the following kind:
 (a) the information specified for the medicine in the document titled CTD Module 1: Administrative information and prescribing information for Australia (Version 4.3, December 2020) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument; and
 (b) the information specified for the medicine in the document titled Mandatory requirements for an effective application (Version 4.1, June 2022) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The documents mentioned in paragraphs (a) and (b) are published at www.tga.gov.au.