Commonwealth Consolidated Regulations

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Application of registration or listing number to goods

             (1)  For the purposes of paragraphs 19D(3)(c) and (4)(c) 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:

                     (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)  unless subparagraph (iii) applies--"AUST L" in the case of listed goods; and

                            (iii)  "AUST L(A)" in the case of goods listed under section 26AE of the Act;

                            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), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.

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