Therapeutic Goods Regulations 1990

A sponsor of therapeutic goods (other than medical devices) commits an offence if:

the sponsor supplies the goods on or after 1 July 2004; and

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

the goods are of a kind specified in Part 1 of Schedule 10; and

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

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.

Strict liability applies to the physical elements mentioned in paragraphs (1)(c), (d) and (e).

The information in relation to the therapeutic goods must be included in:

the consumer medicine information document required under regulation 9A; and

the product information in relation to the goods.

In this regulation:

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.