Therapeutic Goods Amendment Regulations 2003 (No. 3)1
I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.
Dated 9 October 2003
P. M. JEFFERY
Governor-General
By His Excellency’s Command
TRISH WORTH
Parliamentary Secretary to the Minister for Health and Ageing
1 Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 3).
2 Commencement
These Regulations commence on gazettal.
3 Amendment of Therapeutic Goods Regulations 1990
Schedule 1 amends the Therapeutic Goods Regulations 1990.
Schedule 1 Amendments
(regulation 3)
[1] Subregulation 9A (1)
after the penalty, insert
Note Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell — see regulation 9B.
[2] After regulation 9A
insert in Part 2A
9B Information about therapeutic goods manufactured using human embryos
(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; 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.
Penalty: 10 penalty units.
(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 patient information document required under regulation 9A; and
(b) the product information in relation to the goods.
(4) In this regulation:
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.
product information, in relation to therapeutic goods, has the meaning given by subsection 9D (5) of the Act.
(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.
Notes
1. These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111 and 151.
2. Notified in the Commonwealth of Australia Gazette on 16 October 2003.