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Permitted indications for listed medicines guidance

7 March 2018

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Appendix 1: Permitted indication assessment tool

Answer the following questions in relation to the proposed indication Yes No
  1. Does the indication describe a therapeutic use for the goods?
  1. Does the structure of the indication include a target and an action?
  1. Is the indication substantially different to other available permitted indications? (i.e. is the meaning different from an existing permitted indication?)
  1. Does the indication only refer to:
    • health enhancement
    • health maintenance
    • prevention or alleviation of a dietary deficiency; or
    • a health benefit (such as symptom relief) for a non-serious disease, ailment, defect or injury?
  1. If referring to a disease, condition, ailment or defect is it self-diagnosable (or appropriate to be self-managed after initial diagnosis by a Doctor)? If not applicable, move to next question.
  1. If referring to a disease, condition, ailment or defect is it self-manageable (i.e. it does not require regular supervision by a healthcare professional)? If not applicable, move to next question.
  1. Is the terminology of the indication consistent with the relevant paradigm (scientific or traditional)?
  1. Is the indication consistent with a documented tradition of use; or scientifically plausible?

If you answered NO to any question numbered 1 to 8 the indication is NOT SUITABLE.

If you answered YES to questions 1 to 8, continue with questions 9 to 17.

  1. Does the indication contain or imply a prohibited representation (i.e. refer to abortifacient action or the following diseases: neoplastic, sexually transmitted, HIV, AIDS, HCV, mental illness)? (Not applicable for sunscreen indications)
  1. Does the indication contain, or imply, a restricted representation (i.e. a serious form of a disease, condition, ailment or defect specified in the Therapeutic Goods Advertising Code)?
  1. If referring to a disease, ailment, defect or injury does it refer to prevention, or complete resolution of the disease, ailment, defect or injury? If not applicable, move to next question
  1. Does the indication contain any implication that the medicine is infallible, unfailing, magical, miraculous, or that it is a certain, or guaranteed cure?
  1. Does the indication contain any claim, statement or implication that it is effective in all cases or would raise unrealistic expectations of effectiveness?
  1. Could the indication cause the consumer to delay seeking medical treatment and would this be detrimental?
  1. Could the indication mislead, or be likely to mislead consumers?
  1. Does the indication include scientific or other terms that are likely to be not easily understood by consumers? (scientific indications only)
  1. Does the indication imply that harm may result from not using the medication?
If you ticked YES to any question numbered 9 to 17, the indication is NOT SUITABLE.

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