The Permissible Indications Determination requires certain label statements, depending on the potential risk associated with the use of a specific indication. Label statements are being brought into line with the language being used in the new advertising code moving from ‘seek advice’ to ‘talk to’. Generally speaking, these terms would be considered interchangeable, so current products using these indications will not be required to change their medicine labels immediately, but may updated at the next print run.
Table 7. Examples of symptoms statements in the Permissible Indications Determination
|Label statement||When required|
|If symptoms persist, talk to your health professional.||Indications relating to a symptom of a disease, condition, ailment or defect other than those below.|
|If you are concerned about the health of yourself or your baby, talk to your health practitioner.||Indications directed to post-partum women e.g. breast feeding women.|
|Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.||All indications directed to pregnant women.|
|If symptoms persist or worsen talk to your medical practitioner.||Indications that must be qualified by ‘medically diagnosed’|
|If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner.||Indications for usually chronic or recurring conditions that must be qualified by ‘medically diagnosed’ e.g. ‘gout’.|
Note that required label statements for permitted indications relating to seeking advice from a ‘health professional’, ‘health practitioner’ or a ‘medical practitioner’ have a specific intent and meaning:
- a health professionals as defined in the Act is any person belonging to certain health occupations such as medical practitioners, herbalists, naturopaths etc.
- a health practitioners as defined in the Act, is a person who, under a law of a State or internal Territory, is registered or licensed to practice certain health professions such as nursing, pharmacy etc. The label symptom statement relating to health practitioners have been intentionally specified in a small number of cases (e.g. for indications qualified by ‘medically diagnosed’) to avoid the indications being treated as restricted representations. Similarly, the statements for indications directed at pregnant women refer to health practitioner to reflect the potential vulnerability of this specific population group.
- a medical practitioner is a person who is registered under the Health Practitioner Regulation National Law in the medical profession. For a small number of indications, sponsors must use the term medical practitioner (or words to the effect, e.g. doctor) on their label to reflect the more serious nature of the indication.
Please check for updates to label statements for your products prior to your next print run.