Source: https://www.legislation.gov.au/Details/F2000B00054
Timestamp: 2019-12-06 03:59:48
Document Index: 549316681

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Therapeutic Goods Amendment Regulations 2000 (No. 2)
Details: F2000B00054
- F2000B00054
SR 2000 No. 48 Regulations as made
Gazetted 19 Apr 2000
Statutory Rules 2000 No. 48
Dated 12 April 2000
Therapeutic Goods Amendment Regulations 2000 (No. 2)1
Statutory Rules 2000 No. 482
These Regulations are the Therapeutic Goods Amendment Regulations 2000 (No. 2).
Complaints Resolution Panel means the panel established under regulation 42R.
[2] Regulation 2, after definition of designated orphan drug
designated therapeutic goods means therapeutic goods other than:
(b) goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and
(c) goods included in Schedule 4 or 8 to the Poisons Standard.
[3] Regulation 2, after the definition of fungicide
generic information, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:
(a) an advertisement about the goods; or
(b) generic information included in, or associated (directly or indirectly) with, an advertisement about therapeutic goods; or
(c) bona fide news.
[4] Regulation 2, after definition of required representation
restricted representation means a representation referred to in subregulation 7A (1).
[5] Regulation 2, after definition semi critical medical device
serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:
(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or
(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.
[6] Regulation 2, definition of Therapeutic Goods Advertising Code
Therapeutic Goods Advertising Code means the Code known as the Therapeutic Goods Advertising Code as in force from time to time.
[7] Regulation 5B, definition of designated therapeutic goods
[8] Paragraph 5G (1) (d)
regulation 6A.
regulation 6A; and
[9] After paragraph 5G (1) (d)
(e) does not contain a restricted representation, about the goods, the use of which has not been approved under subregulation 7C (1) or permitted under subregulation 9 (1).
[10] Subregulation 5J (3)
(3) Unless the approval of the advertisement is withdrawn, an approval number expires at the end of 2 years from the date on which it is allocated.
[11] Subregulation 5L (2)
under Division 5.
under subregulation 42ZCAB (1).
[12] After subregulation 5Q (5)
(5A) The Secretary may delegate the Secretary’s power under subregulation 5L (2) to withdraw the approval of approved advertisements to the chairperson of the Complaints Resolution Panel.
[13] After paragraph 6 (1) (b)
(ba) that contains a restricted representation, about those goods, the use of which has not been approved under subregulation 7C (1) or permitted under subregulation 9 (1); or
[14] Before regulation 6A
6AA Definitions for Division 4
applicant means an applicant for approval of the use of a restricted representation in an advertisement about therapeutic goods.
approval holder, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.
6AB Compliance with Code
An advertisement about therapeutic goods to which this Part applies must comply with the Therapeutic Goods Advertising Code.
[15] After regulation 7
7A Restricted representations
(1) For the purposes of this Part, a representation in an advertisement about therapeutic goods that refers to a serious form of a disease, condition, ailment or defect specified in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is a restricted representation about therapeutic goods.
(2) A person must not use a restricted representation in an advertisement about therapeutic goods unless the Secretary:
(a) has approved its use under subregulation 7C (1); or
(b) has permitted its use under subregulation 9 (1).
7B Applications for approval of use of restricted representation
An application for approval of the use of a restricted representation must be:
(b) signed by or on behalf of the applicant.
7C Approval of use of restricted representation
(1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:
(a) the representation is accurate and balanced; and
(b) the representation is not misleading or likely to be misleading.
(2) Otherwise, the Secretary must refuse to approve the use of the restricted representation.
(3) An approval may be subject to conditions imposed by the Secretary.
(4) In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:
(a) any recommendation of the Therapeutic Goods Advertising Code Council; and
(b) any advice of the Complementary Medicines Evaluation Committee or the Medicines Evaluation Committee; and
(c) the public interest criteria mentioned in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code.
7D Notice of approval or refusal
(1) The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, the use of a restricted representation.
(2) If written notice is not given to the applicant within the period of 60 days after the day on which the application was made (or within such longer period as the Secretary specifies by written notice to the applicant before the end of that period), the Secretary is taken to have approved the use of the restricted representation at the end of the period.
(3) If an approval is subject to conditions, the conditions must be set out in the notice.
(4) A notice of refusal to approve the use of a restricted representation must:
(b) inform the applicant of the applicant’s right to have the Secretary’s decision reviewed by the Minister under regulation 7G.
7E Variation of conditions of approval
(1) The Secretary, by written notice to an approval holder, may vary any condition of approval of the use of a restricted representation.
(b) inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 7G.
7F Withdrawal of approval
(1) The Secretary, by written notice, may withdraw the approval of the use of a restricted representation if:
(i) information given by the applicant in the application was false or incorrect and the Secretary, or the Minister on review of a decision of the Secretary under regulation 7C or 7E, relied on the information in deciding to approve the use of the representation; or
(ii) the restricted representation has become a prohibited representation; or
(iii) there has been a breach of a condition of approval; or
(i) additional information about the safety of the therapeutic goods becomes available; and
(ii) the Secretary is satisfied that, if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation.
(a) give the Secretary’s reasons for the withdrawal; and
7G Review by Minister of decisions of the Secretary
(1) An applicant or approval holder who is dissatisfied with a decision of the Secretary under regulation 7C, 7E or 7F may request the Minister, in writing, to review the decision.
(2) The request must be made within 30 days after notice of the decision is given to the applicant or approval holder.
(3) The Minister must reconsider the decision within 30 days after receiving a request, and may:
(b) revoke the Secretary’s decision and make a decision in substitution for the Secretary’s decision.
7H Notice of Minister’s decisions
(1) The Minister must give written notice to the applicant or approval holder of the decision of the Minister under regulation 7G.
(b) call attention to the right of the applicant or approval holder to apply to the Administrative Appeals Tribunal under regulation 7J for a review of the Minister’s decision.
7J Review by Tribunal of decisions of Minister
An application may be made to the Administrative Appeals Tribunal for a review of a decision of the Minister under regulation 7G.
[16] Regulation 9
9 Use of restricted or prohibited representations
(1) The Secretary may, by order in writing published in the Gazette or on the Department’s web site on the Internet, permit, in relation to therapeutic goods, the use of a restricted representation (including its use on the label of the goods or in information included in the package in which the goods are contained).
(2) The Secretary may, by order in writing published in the Gazette or on the Department’s web site on the Internet, permit a prohibited representation to be included on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.
9AA Orders about advertisements
(1) On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to an advertisement about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:
(a) publish a retraction;
(b) publish a correction;
(c) recover any advertisement that is still in circulation;
(d) destroy the advertisement.
(2) An order under subregulation (1) may be subject to conditions imposed by the Secretary.
(3) The Secretary may delegate all or any of the Secretary’s powers under subregulation (1) to the chairperson of the Complaints Resolution Panel.
[17] Part 2, Division 5
[18] After Part 2A
Part 2B Generic information about ingredients or components
9P Application of Part
This Part applies to generic information about goods that:
(a) may be used as an ingredient or component in the manufacture of therapeutic goods; and
(b) although not presented for supply as therapeutic goods, come within the meaning of therapeutic goods because they are represented to be:
(ii) for use as an ingredient or component in the manufacture of other therapeutic goods.
9Q Compliance with clauses 4.1 to 4.4 of Code
Generic information to which this Part applies must comply with clauses 4.1, 4.2, 4.3 and 4.4 of Therapeutic Goods Advertising Code as if those clauses applied to generic information in the same way as they apply to advertisements.
9R Offences — publication of generic information
(1) A person must not publish generic information about therapeutic goods if:
(a) it is false or misleading in a material particular; or
(b) it contains a claim that has not been verified; or
(c) it contains any matter that is likely to lead a person to believe that:
(i) a person is suffering from a serious disease, condition, ailment or defect; or
(ii) harmful consequences may result from the person’s failure to use the goods; or
(d) it contains a claim, statement or implication that the goods are effective treatment for all forms of a disease, condition, ailment or defect; or
(e) it encourages self-diagnosis or self-treatment of potentially serious diseases, conditions, ailments or defects; or
(f) it is directed to persons under 18 years and the information is about therapeutic goods not listed in Appendix 5 to the Therapeutic Goods Advertising Code.
(2) A person must not insert in print media generic information about therapeutic goods if:
(3) A person must not publish generic information about therapeutic goods if:
(a) that information includes or implies an endorsement of the goods by:
(ii) a health care professional; or
(b) that information:
(i) includes or implies an endorsement of the goods by a body or association that represents the interests of health consumers or health care professions, or conducts or funds research into diseases, conditions, ailments or defects; and
(A) disclose the nature of the endorsement; and
(B) identify the body or association making the endorsement; and
(C) indicate that the endorsement has been authenticated; and
(D) acknowledge any valuable consideration received by the body or association for the endorsement.
(4) A person must not insert in print media generic information about therapeutic goods if:
9S Orders about generic information
(1) On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to generic information about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:
(c) recover any generic information that is still in circulation;
(d) destroy the generic information.
[19] Subregulation 42H (1)
(1) A body mentioned in regulation 42C may appoint up to 2 persons who are not members of the Council to each be available to be the alternate of a member nominated to the Council by that body.
[20] Subregulation 42H (3)
(3) If a person appointed by a body mentioned in regulation 42C ceases to hold office as a member:
(a) the person who was the person’s alternate under subregulation (2) immediately before the person ceased to hold office; or
(b) in the absence of an alternate under paragraph (a), a person who was, under subregulation (1), available to be the alternate of the person who ceased to hold office;
is entitled to attend meetings of the Council while the office is vacant and, when so attending, is taken to be a member of the Council.
(3A) The person described in paragraph 3 (a) or (b) is taken to be the alternate of a person nominated to the vacant office until a new alternate is appointed.
[21] After subregulation 42J (3)
(4) The chairperson of the Complaints Resolution Panel may attend meetings of the Council as an observer having the same entitlements as an observer mentioned in subregulation (3).
[22] Part 6, Division 3, heading
Division 3 Complaints Resolution Panel
[23] Paragraph 42S (a)
under Part 2, Division 5;
and generic information under Subdivision 2;
[24] Paragraph 42S (b)
[25] After subregulation 42T (1)
(1A) However, the chairperson must nominate an additional member for a meeting of the Panel at which a complaint about a therapeutic device is to be considered.
(1B) A person nominated under subregulation (1A) must:
(a) have appropriate expertise and experience; and
(b) be taken from a list of persons given to the chairperson by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers, suppliers, exporters and importers of therapeutic devices.
[26] Subregulation 42W (2)
a person who is not a member of the Panel
up to 2 persons who are not members of the Panel to each be available
[27] After subregulation 42W (3)
(3A) If a person appointed by a body mentioned in paragraph 42T (1) (b), (c) or (d) ceases to hold office as a member:
(3B) The person described in paragraph 3A (a) or (b) is taken to be the alternate of a person nominated to the vacant office until a new alternate is appointed.
[28] Subregulation 42W (4)
If a person ceases to hold office as a member:
If the chairperson ceases to hold office:
[29] After paragraph 42Y (c)
(ca) a consumer member mentioned in paragraph 42T (1) (c);
[30] Paragraph 42Y (e)
regulation 42X.
regulation 42X;
[31] After paragraph 42Y (e)
(f) if the meeting is one at which a complaint about a therapeutic device is to be considered — the person nominated by the chairperson under subregulation 42T (1A) for that meeting.
[32] Regulation 42ZC
42ZC Reports to Council
(1) The Panel must give to the Therapeutic Goods Advertising Code Council periodic written reports on the operation of the Panel during a reporting period.
(2) Each reporting period must be for a consecutive period of not more than 12 months.
(3) The Panel must consult with the Therapeutic Goods Advertising Code Council to determine the first reporting period.
(4) A report must be given as soon as practicable after the end of the reporting period to which it relates.
Subdivision 2 Procedure — Complaints about advertisements and generic information
42ZCAA Definitions for Subdivision 2
complaint means a complaint about an advertisement or generic information made to the Complaints Resolution Panel in accordance with regulation 42ZCAB.
person apparently responsible, in relation to a complaint about an advertisement or generic information, means the person who, based on the complaint and the assessment of the Complaints Resolution Panel, appears to be responsible for requesting the publication or insertion of the advertisement or generic information in specified media.
(a) mainstream media;
(c) television;
(e) outdoor displays, including billboards or posters exhibited on or in public transport.
Note Mainstream media is defined in section 42B of the Act.
42ZCAB Complaints about advertisements or generic information
(1) A person may complain in writing to the Complaints Resolution Panel that:
(a) an advertisement about designated therapeutic goods that is published or inserted in specified media contravenes:
(i) subsection 22 (5), or section 42C or 42D, of the Act; or
(ii) these Regulations; or
(iii) the Therapeutic Goods Advertising Code; or
(b) an advertisement about therapeutic devices that is published or inserted in specified media contravenes:
(i) subsection 22 (5) of the Act; or
(iii) the Therapeutic Goods Advertising Code.
(2) A person may complain in writing to the Complaints Resolution Panel that generic information, to which Part 2B applies, that is published or inserted in specified media contravenes regulation 9Q or 9R.
42ZCAC Procedure on receipt of a complaint
(1) If the Panel receives a complaint, the Panel:
(a) must give, to the complainant (if known) and the person apparently responsible, written notice that the complaint has been received; and
(b) may make initial inquiries so that the details and background of the complaint are available to the Panel when it considers the complaint.
(b) invite the complainant (if known) and the person apparently responsible to send written submissions to the Panel, together with any supporting documents.
42ZCAD Dealing with complaint
(1) The Panel must consider a complaint and decide whether the complaint is justified.
(2) In considering the complaint, the Panel must have regard to:
(a) any written submissions and documents given to the Panel; and
(b) the results of its inquiries (if any); and
(c) information obtained about the complaint.
42ZCAE Powers of Panel
(1) The Panel may inform itself on any matter, and consult such persons, as it thinks fit.
(2) The Panel may require the person apparently responsible or the sponsor to produce evidence in support of a claim made in an advertisement or in generic information that is the subject of a complaint.
42ZCAF Withdrawal of complaint
(1) The complainant may withdraw a complaint at any time.
(2) The Panel may treat a complaint as withdrawn if, before dealing with the complaint under regulation 42ZCAD, the Panel is satisfied that:
(b) the subject matter of the complaint has been dealt with by the Panel or by another authority; or
(c) the subject matter of the complaint can more effectively or conveniently be dealt with by another authority; or
(i) the complainant does not intend to proceed with the complaint; and
(ii) on the basis of the complaint, there does not appear to have been any contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
(3) If the complaint is withdrawn under subregulation (1), the Panel must inform the person apparently responsible of the fact.
(4) If the Panel treats a complaint as withdrawn under subregulation (2), the Panel must give written notice to the complainant (if known) and the person apparently responsible of the Panel’s decision and the reasons for the decision.
42ZCAG Dealing with subject matter despite withdrawal of complaint
(1) The Panel may deal with the subject matter of a complaint despite the withdrawal of the complaint if it appears to the Panel that there may have been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.
(2) If the Panel decides to deal with the subject matter of a complaint under subregulation (1), the Panel must give written notice of its decision and the reasons for the decision to the person apparently responsible.
42ZCAH Dealing with matters not specified in complaint
(1) The Panel may deal with a matter that is not mentioned in a complaint if it is satisfied that the advertisement or generic information to which the complaint relates may contravene the Act, these Regulations or the Therapeutic Goods Advertising Code in some other way.
(2) If the Panel decides to deal with a matter under subregulation (1), the Panel must give written notice of its decision to the person apparently responsible.
(a) give details of the matter not mentioned in the complaint and the possible contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code that are to be dealt with by the Panel; and
(b) invite the person apparently responsible to send written submissions to the Panel, together with any supporting documents.
(4) This regulation applies despite the withdrawal of the complaint.
42ZCAI Action that Panel may take
(1) If, in relation to a complaint about an advertisement, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:
(b) publish a retraction;
(c) publish a correction.
(2) If, in relation to a complaint about generic information, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:
(a) withdraw the generic information;
(3) If the person apparently responsible does not comply with a request under subregulation (1) or (2) within 14 days after the request is made, the Panel may make a recommendation to the Secretary about the advertisement or generic information.
(4) Without limiting subregulation (3), the Panel may recommend that the Secretary do one or more of the following:
(a) if the advertisement is an approved advertisement — withdraw the approval of the advertisement;
(b) cancel the registration or listing of the goods under paragraph 30 (2) (e) of the Act;
(c) order the publication of a retraction;
(d) order the publication of a correction;
(e) order the recovery of any advertisement or generic information that is still in circulation;
(f) order the destruction of the advertisement or generic information.
(5) The Panel must give written notice of a decision under subregulation (1) or (2), or a recommendation under subregulation (3), to the complainant (if known) and the person apparently responsible, setting out its reasons.
42ZCAJ Panel not to deal with complaint if court proceedings begun
(1) The Panel cannot deal with a complaint if a proceeding has begun in a court about the subject matter of the complaint and the proceeding has not been finally disposed of.
(2) If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of.
42ZCAK Procedure generally
So far as these Regulations do not provide for the procedure of the Panel, the Panel may determine its own procedure.
[33] Subregulation 47 (3)
regulation 5Q.
regulation 5Q or subregulation 9AA (3) or 9S (3).
[34] Subregulation 48 (1), definition of initial decision, after paragraph (b)
(ba) subregulation 9AA (1);
(bb) subregulation 9S (1);
[35] Schedule 2, Part 1, items 1 and 2
a representation about a disease, condition, ailment or defect specified in Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code
[36] Schedule 2, Part 1, item 4
a representation referred to in paragraph 7.1 (a) or (b) of the Therapeutic Goods Advertising Code
[37] Schedule 2, Part 1, item 8
a representation referred to in paragraph 7.2 (a) or (b) of the Therapeutic Goods Advertising Code
[38] Schedule 4, Part 1, paragraph 5 (b)
a condition which is referred to in clause 4 of
a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to
[39] Additional amendments
The following provisions are amended by omitting ‘a condition referred to in clause 4 of’ and inserting ‘a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to’:
· Schedule 4, Part 1, item 3
· Schedule 4, Part 1, item 6
· Schedule 4, Part 1, item 7
· Schedule 4, Part 1, paragraph 8 (b)
· Schedule 4, Part 1, paragraph 10 (e)
· Schedule 5, item 8.
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 No. 29.
2. Made by the Governor-General on 12 April 2000, and notified in the Commonwealth of Australia Gazette on 19 April 2000.