Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
7General requirements, including label presentation
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7 General requirements, including label presentation
(1) The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine.
(2) The information required by this Order to be included on a label or labels must:
(a) be clearly visible and not be obscured; and
(b) be in English; and
(c) be in durable and legible characters; and
(d) unless otherwise specified elsewhere in this Order, be displayed in text size of not less than 1.5 millimetres, except
(i) in the case of the registration number, which must be in a text size of not less than 1.0 millimetre height as required by subparagraph 15(1)(c)(i) of the Regulations; and
(e) be in a colour or colours contrasting strongly with the background, except for:
(i) the expiry date and expiry date prefix; and
(ii) the batch number and batch number prefix
when that information is embossed or debossed and not printed; and
(f) unless otherwise specified elsewhere in this Order, be in metric units of measurement.