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ARGOM Appendix 3: Guidelines on presentation aspects of OTC applications

Australian regulatory guidelines for over-the-counter medicines (ARGOM)

12 October 2012

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Version 1.0

The presentation of over-the-counter (OTC) medicines is critical for their safe use. 'Presentation' is defined in Section 3 of the Therapeutic Goods Act 1989 (the Act) as 'the way in which the goods are presented for supply, including matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods'. Presentation is one of the factors that must be taken into account by the TGA delegate in making decisions on the registration of medicines (Section 25 of the Act).

This part of the guidance document describes various aspects of presentation and gives guidance on what constitutes acceptable presentation for OTC goods. It is divided into five sections as follows:

  1. Unacceptable presentation
  2. Product name
  3. Labelling
  4. Product Information (PI)
  5. Consumer Medicine Information (CMI)

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