Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A sponsor of therapeutic goods (other than medical devices) commits an offence if:
(a) the sponsor supplies the goods on or after 1 July 2004; and
(b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and
(c) the goods are of a kind specified in Part 1 of Schedule 10; and
(d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and
(e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.
(2) Strict liability applies to the physical elements mentioned in paragraphs (1)(c), (d) and (e).
(3) The information in relation to the therapeutic goods must be included in:
(a) the consumer medicine information document required under regulation 9A; and
(b) the product information in relation to the goods.
"human embryo" means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro - nuclei or the initiation of its development by other means.
"human embryonic stem cell" means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.
(5) For the purposes of the definition of human embryo in
subregulation (4), in working out the length of the period of
development of a human embryo, any period when the development of the embryo
is suspended is to be disregarded.