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Advertising pharmacist-only (Schedule 3) medicines
In Australia, all advertisements for medicines must comply with the relevant legislation, and not all medicines can be advertised to the public. For medicines that can be advertised to the public, there are requirements set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). Special requirements apply to the advertising of Schedule 3 pharmacist-only medicines.
About Schedule 3 medicines
The Poisons Standard classifies substances, including medicine ingredients, into different schedules signifying the degree of risk and control recommended over their availability to the public.
Schedule 3 medicines are pharmacist-only medicines. They are available from pharmacies without a prescription; however, a pharmacist must be consulted to ensure professional advice is received. Schedule 3 medicines will have the words 'PHARMACIST ONLY MEDICINE' on the label.
Not all Schedule 3 medicines can be advertised to consumers. To determine whether a Schedule 3 medicine can be advertised, you must check that all of the Schedule 3 ingredients are listed in Appendix H of the Poisons Standard.
Mandatory requirements for advertising Schedule 3 (Appendix H) medicines
The Code requires advertising for Schedule 3 (Appendix H) medicines to prominently display or communicate the statement:
'ASK YOUR PHARMACIST - THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU'
The purpose of this statement is to alert consumers that it is necessary to engage with a pharmacist who can assess the suitability of the medicine.
This requirement does not apply to:
- labels, patient information leaflets or Consumer Medicine Information (CMI)
- an advertisement displaying only the name or picture of the product or its price or point of sale (where it is sold), provided the advertisement does not contain or imply a claim relating to therapeutic use.
Prominently displayed or communicated
In order to 'prominently display or communicate the statement', advertisers need to ensure that:
- visual statements stand out so they are easily read from a reasonable viewing distance
- spoken statements are able to be clearly heard and understood
- the statement are repeated as often as necessary to ensure that it is likely to be noticed by the viewer or listener.
Other advertising requirements
As well as the particular requirements around advertising Schedule 3 (Appendix H) medicines, advertisers must comply with the other relevant requirements in the Code. For example, the Code specifies that:
- advertising must be accurate, balanced, truthful and not misleading
- advertisements for analgesic medicines must prominently display or communicate the statement 'INCORRECT USE COULD BE HARMFUL'.
However, advertisements for these medicines do not need the 'ALWAYS READ THE LABEL', 'THIS MEDICINE MAY NOT BE RIGHT FOR YOU...', 'FOLLOW THE DIRECTIONS FOR USE' or the symptoms statements required in the advertising for other types of medicines.
Advertising directed to healthcare professionals
These requirements are not applicable to advertisements that are only accessible by health care professionals or persons engaged in wholesale trade.
Advice or information given directly to a patient by a pharmacist in the course of the patient's treatment is not subject to the requirements of the Code.
For further information and resources on advertising therapeutic goods, visit the TGA Advertising Hub.