Permitted indications determination
Permitted indications determination for labelling and packaging of medicines and biologicals.
'Indications' are statements that describe the specific therapeutic use for a medicine. They describe a medicine's claimed purpose or health benefit, for example: 'relieves coughs'. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance).
Indications available for use for listed medicines are included in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination (the Permissible Indications Determination). The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for use in listed medicines, provided appropriate evidence is held by the medicine sponsor.