Source: http://tgacc.com.au/viewAmendment.cfm?id=42
Timestamp: 2018-04-22 15:59:10
Document Index: 718488611

Matched Legal Cases: ['art 2', 'art 5', 'art 2', 'art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 2', 'art 5']

1	Name of Regulations
3	Amendment of Therapeutic Goods Regulations 1990
Schedule 1	Amendments
[21]	Regulation 2, definitions of generic information, prohibited representation, required representation, restricted representation and specified media
[21]	After regulation 3
[21]	Part 2, Division 1
(1)	This Part applies to advertisements to which Part 5-1 of the Act applies.
(2)	For subsection 42AA (2) of the Act, the bodies mentioned in Schedule 1 are prescribed.
[21]	Regulation 5B, definition of approved advertisement
[21]	After regulation 5B
(a)	the Internet;
(b)	electronic mail;
(c)	narrowcast transmission, being a system the reception of which is limited:
(i)	by being targeted to special interest groups; or
(ii)	by being intended only for limited locations (for example, arenas or business premises); or
(iii)	by being provided during a limited period or to cover a special event; or
(iv)	because it provides programs of limited appeal; or
(v)	for any other reason;
(d)	short message service (SMS), being a system enabling the transmission of short text messages from a digital mobile telephone to another digital mobile telephone;
(e)	multimedia messaging service (MMS), being a system enabling the transmission of visual communication, voice communication or electronic mail from a digital mobile telephone to:
(i)	another digital mobile telephone; or
(ii)	an electronic mail address.
[21]	Paragraph 5G (1) (d)
[21]	Paragraph 5G (1) (e)
(e)	does not contain a restricted representation about the goods the use of which has not been approved under section 42DF of the Act or permitted under subsection 42DK (1) of the Act.
[21]	Subregulations 5Q (3) and (4)
(3)	The Secretary may delegate to the CHCA the Secretary’s power under regulation 5G to approve or refuse to approve an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be published or used in specified media of the kind mentioned in paragraph (a), (c) or (d) of the definition of specified media in section 42B of the Act.
(4)	The Secretary may delegate to the ASMI the following powers of the Secretary under regulation 5G:
(a)	the power to approve or refuse to approve an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be broadcast in broadcast media;
(b)	the power to approve or refuse to approve an advertisement about designated therapeutic goods that are not complementary medicines if the advertisement is to be published or broadcast in specified media.
[21]	Part 2, Divisions 3 and 4
(1)	For subsection 42DJ (1) of the Act, the following representations are prohibited representations:
(a)	the representations in column 2 of an item in Part 1 of Schedule 2 about therapeutic goods in column 3 of that item;
(b)	the representations in Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code.
(2)	For subsection 42DJ (2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.
(1)	For subparagraph 42DL (1) (h) (i) of the Act, the following exempt goods are prescribed:
(a)	goods that are exempt from the operation of Part 3-2 of the Act under subregulation 12 (1A) or regulation 12A;
(b)	goods specified in item 1 of Schedule 5.
(2)	For subparagraph 42DL (1) (h) (i) of the Act, the following exempt devices are prescribed:
(a)	devices that are exempt from the operation of Division 3 of Part 4-11 of the Act under subregulation 7.1 (2) or regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;
(b)	devices of a kind mentioned in item 1.1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
(1)	On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to an advertisement or generic information about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:
(a)	withdraw the advertisement or generic information;
(c)	publish a correction;
(d)	recover any advertisement or generic information that is still in circulation;
(e)	destroy the advertisement or generic information;
(f)	withdraw a particular claim or representation made by the advertisement or generic information, and not use that claim or representation in any other advertisement or generic information unless the person satisfies the Secretary that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
[21]	Part 2B
[21]	Paragraph 42B (1) (d)
[21]	Regulation 42Y
(1)	Subject to subregulations (2) and (3), at a meeting of the Panel, a quorum exists if the chairperson and 4 other persons, being members of the Panel or observers to the Panel, are present.
(2)	If a complaint about a medical device or other therapeutic goods is to be considered at a meeting of the Panel, the quorum must include the member nominated under subregulation 42T (1A) for that meeting.
(3)	A quorum for a meeting convened to consider a complaint does not include a member of the Panel if the complaint was made by:
(a)	the member; or
(b)	the body that nominated the member.
[21]	Subregulation 42ZCAB (2)
(2)	A person may complain in writing to the Complaints Resolution Panel that generic information, to which Division 4 of Part 5-1 of the Act applies, that is published or inserted in specified media or broadcast media contravenes that Division.
[21]	Paragraph 42ZCAI (1) (c)
[21]	After paragraph 42ZCAI (1) (c)
(d)	withdraw a particular claim or representation made by the advertisement, and not use that claim or representation in any other advertisement unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
[21]	Paragraph 42ZCAI (2) (c)
[21]	After paragraph 42ZCAI (2) (c)
(d)	withdraw a particular claim or representation made by the generic information, and not use that claim or representation in any other generic information unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
[21]	Paragraph 42ZCAI (4) (h)
[21]	After paragraph 42ZCAI (4) (h)
(i)	order that a particular claim or representation made by the advertisement or generic information be withdrawn, and not be used in any other advertisement or generic information unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
[21]	Subregulation 48 (1), definition of initial decision, paragraphs (a), (b), (ba) and (bb)
(a)	subregulation 9 (1);
[21]	Schedule 2, heading
Schedule 2	Prohibited and required representations
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, 151, 257 and 258.