Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - SCHEDULE 12

Note:   See subregulation   9A(1).

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 (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 (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.