Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination 2018
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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).