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.