Note: See subregulation 9A(1A).
A consumer medicine information document about a medicine must:
(a) be written in English; and
(b) be clearly legible; and
(c) be written in language that will easily be understood by patients; and
(d) be consistent with product information about the product.
2 Specific requirements--document enclosed within packaging etc.
Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the "TGA Consumer Medicine Information (Non-prescription Medicine) Template" (published by the Therapeutic Goods Administration on its website) but:
(a) it is not required to set out the information in the same order as the Template; and
(b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template.
3 Specific requirements--document not enclosed within packaging etc.
Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine:
(a) it must set out all of the information required by the "TGA Consumer Medicine Information (Non-prescription Medicine) Template" (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and
(b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file.