Commonwealth Numbered Regulations

1994 No. 150 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 3

3.1 After regulation 11, insert:

Guidelines for the assessment of intraocular lenses

"11A.(1) Subregulation (2) applies if:

   (a)  an intraocular lens of a kind referred to in item 13 of Part 1 of
        Schedule 4 is included in the Register:

        (i)    after being evaluated under section 25 of the Act for
               registration; or

        (ii)   in accordance with subsection 66 (3) of the Act; and

   (b)  the sponsor of the lens seeks the inclusion in the Register of an
        intraocular lens that is derived from the lens referred to in
        paragraph (a).



"(2) The Secretary may approve, in writing, guidelines to be used for the
purposes of item 14 of Part 1 of Schedule 4 to determine the extent to which
the derived intraocular lens is permitted to differ from the lens from which
it is derived.".