Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 13

Note:       See subregulation 9A(1A).

1   General requirements

                   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.