Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of paragraph 20 (2) (a) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:
(a) in the case of a therapeutic device included in the part of the Register for registered goods -- by writing the number so that it is clearly visible to the user:
(i) on the label on the device; or
(ii) on the label on the outermost level of packaging in which the device is to be supplied to its user;
and, where more than one device is packaged for supply together, on the label on the outermost surface of the outermost package; and
(b) in the case of medicines -- by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and
(c) subject to subregulation (2), in each case -- by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:
(i) "AUST R" in the case of registered goods; and
(ii) "AUST L" in the case of listed goods;
the numbers and letters in each case being not less than 1 millimetre in height.
(2) If the Secretary is satisfied that compliance with paragraph (1) (c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1) (c) (i) or (ii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.