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Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018.
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).