Document ID: chunk:federal_register_of_legislation:F2018L01154:reg:5
Version: federal_register_of_legislation:F2018L01154
Segment Type: reg
Provision Reference: reg 5
Character Range: 1340–1889

5  Kind of information
  For the purposes of subsection 23B(9) of the Act, the application must be accompanied by:
 (a) the information specified in the document titled Common Technical Document Module 1: OTC Medicines, version 1.2, published by the TGA in June 2017; and
 (b) the information required by the document titled Mandatory requirements for an effective over-the-counter medicines application, version 1.1, published by the TGA in March 2016.
Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).