Therapeutic Goods Regulations (Amendment) (Cth)

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Statutory Rules 1997No. 400 1

__________________

Therapeutic Goods Regulations2(Amendment)

I, The 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 18 December 1997.

WILLIAM DEANE

Governor-General

By His Excellency’s Command,

trish worth

Parliamentary Secretary to the

Minister for Health and Family Services

for the Minister for Health and Family Services

____________

1. Amendment

1.1 The Therapeutic Goods Regulations are amended as set out in these Regulations.

[NOTE: These Regulations commence on gazettal: see Acts Interpretation Act 1901, s 48.]

2. Regulation 2 (Interpretation)

2.1 Definition of “Therapeutic Goods Advertising Code”:

Omit the definition, substitute:

“‘Therapeutic Goods Advertising Code’ means the Code known as the Therapeutic Goods Advertising Code published in the Gazette on 10 December 1997, together with any amendments of the Code published by the Minister in the Gazette as forming part of the Code;”.

3. Part 2 (Advertisements)

3.1 Before regulation 4, insert the Division heading:

“Division 1—Application of Part”.

4. New Division 2 of Part 2 (Advertisements)

4.1 After regulation 5A, insert:

“Division 2—Advertisements for which approval is needed

Interpretation

“5B. In this Division:

‘applicant’ means an applicant for approval of an advertisement;

‘approval holder’, in relation to an approved advertisement, means the person to whom notice of approval of the advertisement was given;

‘approval number’ means the distinguishing number allocated to an approved advertisement by the Secretary under regulation 5J;

‘approved advertisement’ means an advertisement:

(a)
approved under regulation 5G, or taken to be approved under subregulation 5H (2), by the Secretary, or approved by the Minister on review under regulation 5M; and
(b)
the approval of which has not been withdrawn;

‘complementary medicine’ means therapeutic goods for oral or dermal use, or for use by inhalation where specified, containing 1 or more active ingredients each of which is a designated active ingredient;

‘designated active ingredient’ means an active ingredient, or a class of active ingredients, mentioned in Schedule 14;

‘designated therapeutic goods’ means any therapeutic goods except:

(a)
therapeutic devices; and
(b)
goods included in Schedule 3, 4 or 8 to the Poisons Standard;

‘mainstream media’ means any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions;

‘NFAA’ means the Nutritional Foods Association of Australia;

‘PMAA’ means the Proprietary Medicines Association of Australia.

Application of Division

“5C.(1) This Division applies to advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in mainstream media on or after 1 January 1998.

“(2) However, this Division does not apply to an advertisement that consists only of one or more of the following:

(a)
the brand name of the goods;
(b)
the price of the goods;
(c)
the type or style of the goods;
(d)
a photographic or other reproduction of the goods that does not contain any claim for therapeutic use in relation to the goods;
(e)
the locations or times at which the goods are offered for sale;
(f)
any other information reasonably necessary to identify the person offering the goods for sale.

Publishing advertisements without approval etc

“5D.(1) A person must not publish or insert in mainstream media an advertisement to which this Division applies that is not an approved advertisement.

Penalty: 10 penalty units.

“(2) A person must not publish or insert in mainstream media an approved advertisement that differs from the advertisement that was approved.

Penalty: 10 penalty units.

“(3) However, subregulation (2) does not apply to an advertisement that differs from the approved advertisement only in respect of a matter mentioned in paragraph 5C (2) (b), (d), (e) or (f).

“(4) A person must not publish or insert in mainstream media an approved advertisement:

(a)
without its approval number; or
(b)
with a number purporting to be its approval number but which is not its approval number; or
(c)
with an approval number that has expired.

Penalty: 10 penalty units.

“(5) A person must not publish or insert in mainstream media an approved advertisement in contravention of a condition of its approval.

Penalty: 10 penalty units.

“(6) This regulation does not apply to a person whose business it is to publish or insert advertisements in any publication, or arrange for the publication or insertion of advertisements in any publication, in relation to an advertisement received by the person for publication or insertion in the ordinary course of business.

“(7) An offence against this regulation is an offence of strict liability.

Publication by a publisher of advertisements

“5E. A person whose business it is to publish or insert advertisements in any publication, or arrange for the publication or insertion of advertisements in any publication, must not, knowingly or recklessly, publish or insert in mainstream media an advertisement to which this Division applies that is not an approved advertisement.

Penalty: 10 penalty units.

Applications for approval of advertisements

“5F. An application for approval of an advertisement must be:

(a)
made to the Secretary in writing, in a form approved by the Secretary; and
(b)
signed by or on behalf of the applicant; and
(c)
accompanied by the prescribed fee.

Approval of advertisements

“5G.(1) If an application is made, the Secretary must approve or refuse to approve the advertisement.

“(2) The Secretary must approve the advertisement if the Secretary is satisfied that it:

(a)
complies with the Therapeutic Goods Advertising Code; and
(b)
does not contain a prohibited representation (whether in express terms or by necessary implication) about the goods; and
(c)
contains a required representation about the goods; and
(d)
does not contain an unacceptable presentation of the goods within the meaning of regulation 6A.

“(3) Otherwise, the Secretary must refuse to approve the advertisement.

“(4) An approval may be subject to conditions imposed by the Secretary.

Notice of approval or refusal to approve an advertisement

“5H.(1) The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, an advertisement.

“(2) If written notice is not given to the applicant within 60 days after the day on which the application was made, or within such longer period as may be agreed in writing between the applicant and the Secretary, the Secretary is taken to have approved the advertisement 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 an advertisement must:

(a)
give the Secretary’s reasons for the refusal; and
(b)
inform the applicant of the applicant’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

Distinguishing numbers for approved advertisements

“5J.(1)The Secretary must allocate a distinguishing number (the ‘approval number’) to each approved advertisement.

“(2) The Secretary must inform the applicant of the approval number at the time of giving notice of the approval of the advertisement.

“(3) An approval number expires at the end of 2 years from the date on which it is allocated.

Variation of conditions of approval

“5K. (1) The Secretary, by written notice to an approval holder, may vary any condition of approval of an approved advertisement.

“(2) The notice must:

(a)
give the Secretary’s reasons for the variation; and
(b)
inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

Withdrawal of approval

“5L.(1)The Secretary, by written notice to an approval holder, may withdraw the approval of an approved advertisement if the Secretary is satisfied that:

(a)
information given by the applicant in the application was false or incorrect and the Secretary or the Minister relied on the information in deciding to approve the advertisement; or
(b)
a person has contravened regulation 5D in relation to the advertisement; or
(c)
there has been a breach of a condition of approval; or
(d)
because of a change to the facts or circumstances existing when the advertisement was approved, the advertisement no longer complies with the Therapeutic Goods Advertising Code; or
(e)
because of a change to the Therapeutic Goods Advertising Code, the advertisement no longer complies with the Code.

“(2) The Secretary, by written notice to an approval holder, may withdraw the approval of an approved advertisement on the recommendation of the Complaints Resolution Panel following a complaint to the Panel under Division 5.

“(3) The notice under subregulation (1) or (2) must:

(a)
give the Secretary’s reasons for the decision; and
(b)
inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

Review by Minister of decisions of the Secretary

“5M.(1) An applicant or approval holder who is dissatisfied with a decision of the Secretary under regulation 5G, 5K or 5L 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) If an applicant requests a review of a decision of the Secretary under regulation 5G, the applicant must at the same time send a copy of the request to the Therapeutic Goods Advertising Code Council.

“(4) The Minister must reconsider the decision of the Secretary as soon as practicable after receiving a request, and may:

(a)
confirm the Secretary’s decision; or
(b)
revoke the Secretary’s decision and make a decision (including a decision to impose conditions) in substitution for the Secretary’s decision.

“(5) In making a decision under subregulation (4), the Minister must take into account any recommendation on the matter made by the Therapeutic Goods Advertising Code Council or the Complaints Resolution Panel, as the case requires.

“(6) Until a decision is made by the Minister, the making of a request does not affect the operation of the Secretary’s decision.

Notice of Minister’s decisions

“5N. (1) The Minister must give written notice to the applicant or approval holder of the decision of the Minister under regulation 5M.

“(2) If, in making a decision on review of a decision by the Secretary under regulation 5G, the Minister does not accept a recommendation of the Therapeutic Goods Advertising Code Council, the Minister must notify the applicant of the fact.

“(3) If the Minister’s decision is to approve an advertisement subject to conditions, the conditions must be set out in the notice.

“(4) The notice must:

(a)
give the Minister’s reasons for the decision; and
(b)
inform the applicant or approval holder of the right of the applicant or approval holder to apply to the Administrative Appeals Tribunal under regulation 5P for a review of the Minister’s decision.

Review by Tribunal of decisions of the Minister

“5P.An application may be made to the Administrative Appeals Tribunal for a review of a decision of the Minister under regulation 5M.

Delegations

“5Q.(1) The Minister may delegate, in writing, a power or function of the Minister under regulation 5M or 5N to:

(a)
an officer of the Department; or
(b)
the National Manager, Therapeutic Goods Administration.

“(2) The Secretary may delegate, in writing, the Secretary’s power under regulation 5G to approve or refuse to approve advertisements to:

(a)
an officer of the Department; or
(b)
a medical practitioner registered in a State or internal Territory who is employed by the government of a State or Territory.

“(3) The Secretary may delegate to the NFAA the Secretary’s power under regulation 5G to approve or refuse to approve advertisements for designated therapeutic goods that are complementary medicines.

“(4) The Secretary may delegate to the PMAA the Secretary’s power under regulation 5G to approve or refuse to approve advertisements for designated therapeutic goods that are not complementary medicines.

“(5) The Secretary may delegate the Secretary’s power under regulation 5L to withdraw the approval of a class of approved advertisements to a person to whom the Secretary has delegated the power to approve the same class of advertisements.

“(6) A person exercising a power under a delegation under this regulation must comply with any conditions imposed or directions given by the Minister or Secretary, as the case requires.”.

5. Part 2 (Advertisements)

5.1 Before regulation 6, insert the Division heading:

“Division 3—Other advertisements”.

6. New regulation 5R

6.1 Before regulation 6, insert in Division 3:

Application of Division

“5R. This Division applies to advertisements about therapeutic goods other than advertisements to which Division 2 applies.”.

7. Part 2 (Advertisements)

7.1 Before regulation 6A, insert the Division heading:

“Division 4—General”.

8 Regulation 8 (Prohibited and required representations)

8.1 Subregulation 8 (1):

Omit “paragraph 6 (1) (a)”, substitute “this Part”.

8.2 Subregulation 8 (2):

Omit “paragraph 6 (1) (b)”, substitute “this Part”.

9. New Division 5 of Part 2 (Advertisements)

9.1 After regulation 9, insert:

“Division 5—Complaints about advertisements

Complaints about advertisements

“9AA. A person may complain in writing to the Complaints Resolution Panel that an advertisement about designated therapeutic goods published or inserted in mainstream media on or after 1 January 1998 contravenes these Regulations or the Therapeutic Goods Advertising Code.

Procedure on receipt of a complaint

“9AB.(1)If the Panel receives a complaint about an advertisement, the Panel must cause a written notice to be given to the complainant and the person apparently responsible for requesting publication or insertion of the advertisement that the complaint has been received.

“(2) The notice must:

(a)
give details of the complaint; and
(b)
invite the complainant and the person apparently responsible for requesting publication or insertion of the advertisement to send written submissions to the Panel, together with any supporting documents.

Dealing with complaint

“9AC.(1) The Panel must consider a complaint, having regard to any written submissions and documents given to the Panel, and must decide whether the complaint is justified.

“(2) If the Panel is satisfied that the complaint is justified, the Panel may request in writing the person apparently responsible for requesting publication or insertion of the advertisement to do one or both of the following:

(a)
withdraw the advertisement;
(b)
publish a retraction.

“(3) If the person apparently responsible for requesting publication or insertion of the advertisement does not comply with a request under subregulation (2) within 14 days after the request is made, the Panel may make a recommendation to the Secretary about the advertisement.

“(4) Without limiting subregulation (3), the Panel may recommend that the Secretary do one or both of the following:

(a)
if the advertisement is an approved advertisement—withdraw the approval of the advertisement;
(b)
whether or not the advertisement is an approved advertisement—cancel the registration or listing of the goods under paragraph 30 (2) (e) of the Act.

“(5) The Panel must give written notice of a decision under subregulation (1), or a recommendation under subregulation (3), to the complainant and the person apparently responsible for requesting publication or insertion of the advertisement, setting out its reasons.

“(6) This regulation applies subject to:

(a)
regulation 9AD (Withdrawal of complaint); and
(b)
regulation 9AE (Panel not to deal with complaint where court proceedings begun).

Withdrawal of complaint

“9AD.(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 9AC, it:

(a)
is satisfied, either after having communicated with the complainant, or having made reasonable attempts to contact the complainant and having failed to do so, that the complainant does not intend to proceed with the complaint; or
(b)
is satisfied that the complaint is trivial, vexatious, misconceived or lacking in substance; or
(c)
is satisfied that the subject matter of the complaint has been dealt with (whether by the Panel or by another authority), or can more effectively or conveniently be dealt with, by another authority.

“(3) If the complaint is withdrawn under subregulation (1), the Panel must inform the person apparently responsible for requesting publication or insertion of the advertisement of the fact.

“(4) If the Panel treats a complaint as withdrawn under subregulation (2), the Panel must give written notice to the complainant and the person apparently responsible for requesting publication or insertion of the advertisement of the Panel’s decision and the reasons for the decision.

Panel not to deal with complaint where court proceedings begun

“9AE.(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.”.

10. Part 6 (Committees)

10.1 Before regulation 34, insert the Division heading:

“Division 1—The Therapeutic Goods Committee, Therapeutic Device Evaluation Committee and Australian Drug Evaluation Committee”.

11. Regulation 37 (Minister or Secretary may seek further advice)

11.1 Omit “Part” (twice occurring), substitute “Division”.

12. Regulation 38 (Tenure of office of members)

12.1 Subregulation 38 (1):

Omit “Part”, substitute “Division”.

12.2 Subregulation 38 (2):

Omit “part”, substitute “Division”.

13. Regulation 39 (Disclosure of interest)

13.1 Subregulation 39 (1):

Omit “Part”, substitute “Division”.

14. Regulation 40 (Acting members)

14.1 Subregulation 40 (1):

Omit “Part:”, substitute “Division:”.

15. Regulation 41 (Meetings of Committees)

15.1 Subregulation 41 (1):

Omit “Part”, substitute “Division”.

16. Regulation 42 (Effect of vacancy on Committees)

16.1 Omit “Part”, substitute “Division”.

17. New Divisions 2 and 3 of Part 6

17.1 After regulation 42, insert in Part 6:

“Division 2—Therapeutic Goods Advertising Code Council

Therapeutic Goods Advertising Code Council

“42A. A committee, to be known as the Therapeutic Goods Advertising Code Council, is established.

Functions of the Council

“42B.(1) The Council’s functions are:

(a)
to consider requirements for the advertising of therapeutic goods and changes to the Therapeutic Goods Advertising Code, to accept submissions for this purpose and to advise the Minister accordingly; and
(b)
to make recommendations to the Minister for achieving greater uniformity in approval processes and standards for advertising therapeutic goods in print and broadcast media; and
(c)
to make recommendations to the Minister about requests for review of a decision of the Secretary under regulation 5G; and
(d)
to consider matters raised at Council meetings by observers to the Council and advise the Minister accordingly; and
(e)
to advise the Minister on any matter referred to the Council by the Minister or Secretary; and
(f)
any other function conferred on the Council by these Regulations.

“(2) The Council may, with the approval of the Minister, appoint sub-committees of its members to inquire into, and report on, any matter that is within the functions of the Council.

Membership of the Council

“42C. The Council is to have 12 members as follows:

(a)
4 manufacturer/supplier members, comprising 1 person nominated by each of the following bodies:
(i)

the NFAA;
(ii)
the PMAA;
(iii)
the Australian Direct Marketing Association;
(iv)
the Direct Sellers Association of Australia;
(b)
2 advertising industry members, comprising 1 person nominated by each of the following bodies:
(i)
the Australian Association of National Advertisers;
(ii)
the Advertising Federation of Australia;
(c)
2 consumer members, comprising 1 person nominated by each of the following bodies:
(i)
the Australian Consumers Association;
(ii)
the Consumers’ Health Forum;
(d)
3 health care professional members comprising:
(i)
1 person nominated by the Australian Traditional Medicines Society; and
(ii)
1 person nominated jointly by the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia; and
(iii)
1 person nominated by the Royal Australian College of General Practitioners;
(e)
1 government member nominated by the Therapeutic Goods Administration.

Term of office of Council members

“42D.(1) A member of the Council holds office for a term of 2 years from the date of the member’s nomination.

“(2) A person cannot hold office for more than 3 consecutive terms.

“(3) This regulation applies subject to:

(a)
regulation 42F (Resignation); and
(b)
regulation 42G (Cessation of membership).

Chairperson of the Council

“42E.(1) At the first meeting of the Council, and afterwards as the occasion arises, the Council must appoint a member of the Council to be the chairperson of the Council.

“(2) The chairperson must be a member nominated by the NFAA or PMAA.

“(3) Unless the chairperson earlier resigns the office, or ceases to be a member of the Council, the chairperson holds office for 1 year from the date of his or her appointment.

Resignation

“42F. (1) A member of the Council nominated by a body may resign as a member by notice in writing to the Council.

(2) The chairperson of the Council may resign the office of chairperson by notice in writing to the Council.

Cessation of membership

“42G.A person ceases to be a member of the Council if:

(a)
the person resigns as a member; or
(b)
the body who nominated the member nominates another person to be a member in place of the person first mentioned; or
(c)
the member is absent for 2 consecutive meetings of the Council without leave of the chairperson; or
(d)
the Council resolves to remove the member.

Alternate members

“42H.(1) A body mentioned in regulation 42C may appoint a person who is not a member of the Council to be the alternate of a member nominated to the Council by that body.

“(2) If a member is absent from a meeting of the Council, the member’s alternate (if any) is entitled to attend the meeting and, when so attending, is taken to be a member of the Council.

“(3) If a person ceases to hold office as a member:

(a)
the person who was the person’s alternate immediately before the person 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; and
(b)
the person is taken to be the alternate of a person nominated to the vacant office until a new alternate is appointed.

“(4) A person appointed by a body as an alternate may resign the appointment by notice in writing to the body.

Observers to Council

“42J.(1) Each of the bodies mentioned in subregulation (2) may nominate a person to attend meetings of the Council as an observer.

“(2) For subregulation (1), the bodies are:

(a)
the Australian Pharmaceutical Manufacturer’s Association; and
(b)
the Cosmetics, Toiletries and Fragrances Association of Australia; and
(c)
the Medical Industries Association of Australia.

“(3) A person nominated as an observer is entitled, until the nomination is revoked:

(a)
to be given the agenda and minutes of Council meetings, as if the person were a member of the Council; and
(b)
by notice in writing to the chairperson suggest agenda items to be considered by the Council; and
(c)
if the person has given notice to the chairperson that the person intends to attend a meeting of the Council—to attend the meeting and vote on any question in accordance with regulation 42L.

Quorum

“42K.At a meeting of the Council, a quorum consists of the chairperson and 5 other members of the Council including:

(a)
a member nominated by the NFAA or PMAA; and
(b)
an advertising industry member; and
(c)
a consumer member; and
(d)
a health care professional member; and
(e)
the government member mentioned in paragraph 42C (e).

Meetings

“42L.(1)Meetings of the Council are to be held at the times and places that the chairperson directs.

“(2) The chairperson is to preside at meetings of the Council at which he or she is present.

“(3) If the chairperson is absent from a meeting, a member nominated by the chairperson or, if no member is nominated, a member chosen by the members of the Council present at the meeting, is to preside.

“(4) A question (other than a question mentioned in subregulation (6)) arising at a meeting of the Council is to be decided by a majority of the votes of the members and observers present and voting, with the person presiding at the meeting having a casting vote.

“(5) An observer is entitled to vote at a meeting on any question affecting the interests of the body nominating the observer.

“(6) The chairperson is to decide whether a question affects the interests of the body nominating an observer.

Effect of vacancy

“42M. The exercise of a power or the performance of a function of the Council is not affected by any vacancy in the membership of the Council.

Disclosure of interest

“42N.(1) A member of the Council (including a person taken to be a member under regulation 42H) who has a direct or indirect pecuniary interest in a matter being considered or about to be considered at a meeting of the Council must, as soon as possible after the relevant facts have come to the member’s knowledge, disclose the nature of the interest at a meeting of the Council.

“(2) The disclosure is to be recorded in the minutes of the meeting and the member must not, unless the Council otherwise determines:

(a)
be present during any deliberation of the Council with respect to the matter; or
(b)
take part in any decision of the Council with respect to that matter.

“(3) For the purpose of the making of a determination in relation to the member who has made the disclosure, any member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates must not:

(a)
be present during any deliberation of the Council for the purpose of making the determination; or
(b)
take part in the making of the determination by the Council.

“(4) Subregulations (1), (2) and (3) apply to an observer to the Council who is intending to take part in any decision of the Council on a matter as they apply to a member.

Procedure generally

“42P. So far as these Regulations do not provide for the procedure of the Council, the Council may determine its own procedure.

Annual report

“42Q. Within 3 months after the end of a financial year, the Council must give the Minister a written report on the operation of the Council for that financial year.

“Division 3—Complaints Resolution Panel

Complaints Resolution Panel

“42R. A committee, to be known as the Complaints Resolution Panel, is established.

Function of the Panel

“42S. The function of the Panel is:

(a)
to receive and consider complaints about advertisements under Part 2, Division 5; and
(b)
to take action and to make recommendations to the Secretary on the complaints in accordance with that Division.

Membership of the Panel

“42T.(1) The panel is to have 8 members, as follows:

(a)
a chairperson nominated by the Therapeutic Goods Advertising Code Council;
(b)
2 members, comprising 1 person nominated by each of the following bodies:
(i)
the NFAA;
(ii)
the PMAA;
(c)
2 consumer members, comprising 1 person nominated by each of the following bodies:
(i)
the Australian Consumers Association;
(ii)
the Consumers’ Health Forum;
(d)
3 health care professional members comprising:
(i)
1 person nominated by the Australian Traditional Medicines Society; and
(ii)
1 person nominated jointly by the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia; and
(iii)
1 person nominated by the Royal Australian College of General Practitioners.

“(2) A person cannot be nominated as a member of the Panel if the nomination would result in there being more than 4 members of the Panel who are members of the Therapeutic Goods Advertising Code Council.

“(3) A person cannot be nominated as a member of the Panel if the person is engaged in the process of approving advertisements for the NFAA or PMAA, under a delegation to the NFAA or PMAA under regulation 5Q.

Term of office of Panel members

“42U.(1) A member of the Panel holds office for a term of 2 years from the date of the member’s nomination.

“(2) A person cannot hold office for more than 3 consecutive terms.

“(3) This regulation applies subject to regulation 42V (Cessation of office).

Cessation of office

“42V. A person ceases to be a member of the Panel if:

(a)
the person resigns as a member by notice in writing to the Panel; or
(b)
the body who nominated the member nominates another person to be a member in place of the person first mentioned; or
(c)
the Panel resolves to remove the member.

Alternate members

“42W.(1) The chairperson may appoint a person who is not a member of the panel to be the alternate chairperson of the Panel.

“(2) A body mentioned in paragraph 42T (1) (b), (c) or (d) may appoint a person who is not a member of the Panel to be the alternate of a member nominated to the Panel by that body.

“(3) If a member (including the chairperson) is absent from a meeting of the Panel, the member’s alternate (if any) is entitled to attend the meeting and, when so attending, is taken to be a member of the Panel.

“(4) If a person ceases to hold office as a member:

(a)
the person who was the person’s alternate immediately before the person ceased to hold office is entitled to attend meetings of the Panel while the office is vacant and, when so attending, is taken to be a member of the Panel; and
(b)
the person is taken to be the alternate of a person nominated to the vacant office until a new alternate is appointed.

“(5) A person appointed by a body as an alternate may resign the appointment by notice in writing to the body.

Observers to Panel

“42X.(1) The Therapeutic Goods Administration must nominate a person to attend meetings of the Panel as an observer.

“(2) The Australia New Zealand Food Authority may nominate a person to attend meetings of the Panel as an observer.

“(3) A person nominated as an observer is entitled, until the nomination is revoked:

(a)
to be given the agenda and minutes of Panel meetings, as if the person were a member of the Panel; and
(b)
by notice in writing to the chairperson suggest agenda items to be considered by the Panel; and
(c)
to attend meetings of the Panel and vote on any question in accordance with regulation 42Z.

Quorum

“42Y.At a meeting of the Panel, a quorum consists of the following persons:

(a)
the chairperson;
(b)
the member nominated by the NFAA;
(c)
the member nominated by the PMAA;
(d)
a health care professional member mentioned in paragraph 42T (1) (d);
(e)
the person nominated as an observer by the Therapeutic Goods Administration under regulation 42X.

Meetings

“42Z.(1)Meetings of the Panel are to be held at the times and places that the chairperson directs.

“(2) The chairperson is to preside at meetings of the Panel at which he or she is present.

“(3) If the chairperson or chairperson’s alternate is absent from a meeting, a member nominated by the chairperson or, if no member is nominated, a member chosen by the members of the Panel present at the meeting, is to preside.

“(4) A question arising at a meeting of the Panel is to be decided by a majority of the votes of the members and observers present and voting, with the person presiding at the meeting having a casting vote.

“(5) An observer is entitled to vote at a meeting on any question affecting the interests of the body nominating the observer.

Effect of vacancy

“42ZA. The exercise of a power or performance of a function of the Panel is not affected by any vacancy in the membership of the Panel.

Disclosure of interest

“42ZB.(1) A member of the Panel (including a person taken to be a member under regulation 42W) who has a direct or indirect pecuniary interest in a matter being considered or about to be considered at a meeting of the Panel must, as soon as possible after the relevant facts have come to the member’s knowledge, disclose the nature of the interest at a meeting of the Panel.

“(2) The disclosure is to be recorded in the minutes of the meeting and the member must not, unless the Panel otherwise determines:

(a)
be present during any deliberation of the Panel with respect to the matter; or
(b)
take part in any decision of the Panel with respect to that matter.

“(3) For the purpose of the making of a determination in relation to the member who has made the disclosure, any member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates must not:

(a)
be present during any deliberation of the Panel for the purpose of making the determination; or
(b)
take part in the making of the determination by the Panel.

“(4) Subregulations (1), (2) and (3) apply to an observer to the Panel who is intending to take part in any decision of the Panel on a matter as they apply to a member.

Procedure generally

“42ZC. So far as these Regulations do not provide for the procedure of the Panel, the Panel may determine its own procedure.”.

18. Regulation 47 (Delegation—powers and functions under these Regulations)

18.1 Add at the end:

“(3) Nothing in subregulation (1) affects the Secretary’s power to delegate a power or function of the Secretary under regulation 5Q.”.

19. Schedule 9 (Fees)

19.1 After item 16, insert:

“17

fee for an application for approval of an advertisement under regulation 5F:

(a)

not more than 100 words

(b)

more than 100 words

(c)

advertorial, more than 300 words

(d)

re-clearance (minor changes to approved advertisement)

(e)

classified

80

100

180

40

40”.

20. New Schedule 14

20.1 After Schedule 13, insert:

SCHEDULE 14

Regulation 5B

DESIGNATED ACTIVE INGREDIENTS

Item	Ingredient or class of ingredient
1	Algae
2	Amino acids
3	Animal bone
4	Bioflavonoids
5	Carotenoids
6	Cellulose and derivatives of cellulose
7	Charcoal
8	Choline salts
9	Essential oils by inhalation
10	Herbal substances, including plant fibres and chlorophyll
11	Homeopathic preparations
12	Microorganisms when taken orally except vaccines or extracts of microorganisms
13	Minerals including mineral salts and naturally occurring minerals
14	Mucopolysaccharides
15	Non-human animal tissues including dried tissue, fats and oils but no other extracts or concentrates
16	Phospholipids
17	Plant enzymes
18	Substances produced by or obtained from bees, including royal jelly, bee pollen and propolis
19	Sugars, polysaccharides and carbohydrates
20	Vitamins

________________________________________________________

NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 December 1997.
2. 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 in the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398 and 399.

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Therapeutic Goods Regulations (Amendment) (Cth)

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