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Therapeutic Goods Amendment Regulations 1999 (No. 2)

Authoritative Version
  • - F1999B00200
  • No longer in force
SR 1999 No. 209 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR20-Sep-1999
Tabled Senate20-Sep-1999
Gazetted 16 Sep 1999
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

Therapeutic Goods Amendment Regulations 1999 (No. 2)

Statutory Rules 1999 No. 209

I, WILLIAM PATRICK DEANE, 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 September 1999.

WILLIAM DEANE
Governor-General

By His Excellency’s Command,

GRANT TAMBLING

Parliamentary Secretary

to the Minister for Health and Aged Care

for the Minister for Health and Aged Care


Therapeutic Goods Amendment Regulations 1999 (No. 2)1

Statutory Rules 1999 No. 2092

made under the

 

 

 

Contents

                                                                                                                 Page

                        1  Name of Regulations                                                         2

                        2  Commencement                                                                2

                        3  Amendment of Therapeutic Goods Regulations 1990            2

                        4  Transitional                                                                        2

Schedule 1       Amendment                                                                 4

 


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1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 1999 (No. 2).

2              Commencement

                These Regulations commence on gazettal.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.

4              Transitional

         (1)   For the first meeting of the National Drugs and Poisons Schedule Committee:

                 (a)     a quorum is 5 jurisdictional members; and

                (b)     the public consultation procedures set out in subdivision 5 of Division 3A of Part 6 of the principal Regulations do not apply.

         (2)   At that meeting, the Committee must make decisions in relation to the classification and scheduling of all substances in relation to which a decision of that kind has been made by AHMAC that does not form part of the first Poisons Standard because the AHMAC decision:

                 (a)     was made on or after 1 April 1999; or

                (b)     was made before 1 April 1999 but had not been published as part of the first Poisons Standard.

         (3)   In making a decision about a substance mentioned in subregulation (2) , the Committee:

                 (a)     may, for subsection 52E (1) of the Act, accept the findings of AHMAC about a matter mentioned in that subsection in connection with that substance; and

                (b)     must take account of the scheduling decision of AHMAC for that substance and the consequences a Committee decision at variance with the AHMAC decision would have for industry and the community.

         (4)   A word or expression used in subregulation (2) and in section 52A of the Act has the same meaning in that subregulation as it has in that section.

         (5)   In this Regulation:

Act means the Therapeutic Goods Act 1989.

AHMAC means the Australian Health Ministers’ Advisory Council and includes a subcommittee of the Council acting on the Council’s behalf.

jurisdictional member has the meaning given by regulation 42ZCE of the principal Regulations.

principal Regulations means the Therapeutic Goods Regulations 1990.


Schedule 1        Amendment

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(regulation 3)

[1]         Part 6, after Division 3

insert

Division 3A           National Drugs and Poisons Schedule Committee

Subdivision 1              Preliminary

42ZCA   Definitions for Division 3A

                In this Division:

Committee means the National Drugs and Poisons Schedule Committee.

Note   The Committee is established by s 52B of the Act.

jurisdictional member has the meaning given by regulation 42ZCE.

Subdivision 2              Functions of Committee

42ZCB   Committee may establish subcommittees

         (1)   To assist in the performance of its functions, the Committee may, with the approval of the National Manager of the Therapeutic Goods Administration, appoint subcommittees, comprising at least 1 member of the Committee and other persons with appropriate expertise and experience.

         (2)   The function of a subcommittee is to inquire into, and report to the Committee on, any matter, within the functions of the Committee, that is referred to it by the Committee.

         (3)   A subcommittee may make recommendations to the Committee.

Note   Section 52C of the Act sets out the functions of the Committee.

Subdivision 3              Constitution of Committee

42ZCC   Membership of Committee

                The Committee is constituted in accordance with this Subdivision.

42ZCD   Committee members

         (1)   The Committee comprises each jurisdictional member and other persons appointed by the Minister under this regulation.

         (2)   The Minister may appoint as a member an expert or a representative.

         (3)   Each of the following persons is an expert:

                (a)    a medical practitioner expert in clinical pharmacology;

               (b)    an expert in veterinary medicine or pathology;

                (c)    an expert in toxicology;

               (d)    an expert in occupational health.

         (4)   Each of the following persons is a representative:

                (a)    a person nominated by the Therapeutic Goods Administration;

               (b)    a person nominated by the National Registration Authority for Agricultural and Veterinary Chemicals;

                (c)    a person nominated by an agency of the New Zealand government responsible for the regulation of medicines for human use;

               (d)    a person nominated by an agency of the New Zealand government responsible for the regulation of agricultural, veterinary and household chemicals;

                (e)    a person whom the Minister is satisfied represents the pharmaceutical, chemical, agricultural and veterinary industries;

                (f)    a person whom the Minister is satisfied represents practising pharmacists;

               (g)    a person whom the Minister is satisfied represents consumers.

         (5)   For each category mentioned in subregulation (4), 1 representative only may be appointed.

42ZCE   Jurisdictional members

                The following persons are jurisdictional members of the Committee:

                (a)    each representative nominated under subsection 52B (3) of the Act;

               (b)    each of the persons appointed as a representative under paragraph 42ZCD (4) (c) or (d).

Note   Only one of the persons appointed as a representative under para 42ZCD (4) (c) or (d) is counted as a jurisdictional member for r 42ZCQ and 42ZCR.

42ZCF    Appointment to be in writing

                An appointment of a Committee member must be in writing.

42ZCG   Appointment of Chair

                The Minister must appoint a Committee member who is a Commonwealth officer to be the chair of the Committee.

Note   Committee members who could be Commonwealth officers are the persons mentioned in para 42ZCD (4) (a) and (b) and the representative nominated by the Commonwealth under subs 52B (3) of the Act.

42ZCH   Term of appointment

         (1)   Subject to regulation 42ZCK, a representative nominated under subsection 52B (3) of the Act is a Committee member for 3 years, or a shorter period stated in the person’s nomination.

         (2)   Subject to regulation 42ZCK, a Committee member appointed under regulation 42ZCD is appointed for the term stated in the member’s appointment.

         (3)   The term stated in an appointment must not be greater than 3 years.

         (4)   However, a Committee member may be nominated or appointed for further terms of up to 3 years each.

         (5)   The Chair of the Committee is appointed as Chair for the term stated in the appointment.

         (6)   The Chair may be reappointed for further terms.

42ZCI     Resignation

                A Committee member may resign by signed notice of resignation given to the Minister.

42ZCJ    Disclosure of interests

         (1)   A Committee member who is aware that he or she has a direct or indirect pecuniary interest in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.

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

                (a)    be present during any deliberation of the Committee about the matter; or

               (b)    take part in any decision of the Committee about that matter.

         (3)   When the Committee is making a determination under subregulation (2) about a member who has made a disclosure, the member, and any other 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 Committee; or

               (b)    take part in making the determination.

42ZCK   Termination of Committee membership

         (1)   The Minister may terminate the membership of a Committee member (including a jurisdictional member) on the grounds of:

                (a)    physical or mental incapacity; or

               (b)    misbehaviour; or

                (c)    incompetence; or

               (d)    inefficiency; or

                (e)    failing to comply, either recklessly or intentionally, with regulation 42ZCJ.

         (2)   The Minister must terminate the membership of a member (including a jurisdictional member) if the member:

                (a)    is convicted of an offence punishable by imprisonment for 1 year or longer; or

               (b)    is absent without leave of absence from 3 consecutive meetings of the Committee.

42ZCL    Leave of absence

         (1)   The Minister may grant leave of absence to the Chair of the Committee.

         (2)   The Chair may grant leave of absence to another Committee member.

         (3)   If the Chair grants leave of absence to another Committee member, the Chair may allow another person to replace the absent member for no more than 2 consecutive meetings.

         (4)   A replacement must have qualifications, experience and, if appropriate, expertise similar to the absent member.

Subdivision 4              Committee procedures

42ZCM   Committee procedures

                For subsection 52B (2) of the Act, this Subdivision sets out the procedures that the Committee must follow in holding meetings.

42ZCN   Committee procedures generally

                In performing its functions, the Committee:

                (a)    must act according to these Regulations; and

               (b)    must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and

                (c)    is not bound by rules of evidence; and

               (d)    may obtain information about an issue in any way it considers appropriate.

42ZCO   Meetings

         (1)   The Chair of the Committee may, by written notice to the Committee, direct the Committee to hold meetings at the times and places, and to deal with matters in the manner, stated in the notice.

         (2)   If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed to meet by videoconference or teleconference or to meet out of session.

         (3)   For this regulation:

out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.

         (4)   Subject to these Regulations, the procedure of a Committee’s meeting is as decided by the Committee.

42ZCP   Presiding member

         (1)   The Chair of the Committee must:

                (a)    preside at a Committee meeting; or

               (b)    nominate, in writing, a member of the Committee to preside at the meeting.

         (2)   If the Chair is temporarily absent from a meeting, the members present must choose a jurisdictional member to preside.

42ZCQ   Quorum

         (1)   At a Committee meeting, a quorum exists if 11 members (including 5 jurisdictional members) are present.

         (2)   For this regulation, only one of the persons appointed as a representative under paragraph 42ZCD (4) (c) or (d) can be counted as a jurisdictional member.

42ZCR   Voting

         (1)   A decision of the Committee is made by a majority of the members present and voting for the decision at a Committee meeting.

         (2)   However, a decision has no effect unless the majority includes a majority of the jurisdictional members present and voting.

         (3)   If both of the persons appointed as a representative under paragraph 42ZCD (4) (c) or (d) are present at a Committee meeting, only one of them may vote on a decision as the jurisdictional member.

         (4)   If it is necessary to determine which of the persons mentioned in subregulation (3) may vote as the jurisdictional member, that person is:

                (a)    for an issue about the regulation of medicines for human use — the person appointed under paragraph 42ZCD (4) (c); or

               (b)    in any other case — the person appointed under paragraph 42ZCD (4) (d).

         (5)   The member presiding at a Committee meeting has a deliberative vote and also has a casting vote:

                (a)    in the event of an equality of votes of all members present; and

               (b)    in the event of an equality of votes of jurisdictional members present.

42ZCS   Records and reports

         (1)   The Committee must keep a record of its proceedings.

         (2)   The Committee must prepare any other report about its activities that is requested by the Minister or the Secretary.

Note   Regulation 42ZCX is about records of scheduling decisions.

Subdivision 5              Scheduling procedures

42ZCT   Definitions for Subdivision 5

                In this Subdivision:

public submission means a submission to the Committee by a person who is not a member of the Committee.

scheduling meeting means a Committee meeting for the scheduling of a substance.

Note   For current Poisons Standard, scheduling and substance, see s 52A of the Act.

42ZCU   Public notice of scheduling meetings

         (1)   Before a scheduling meeting, the Chair of the Committee must publish a notice in the Gazette:

                (a)    mentioning the date of the proposed scheduling meeting; and

               (b)    mentioning each substance to be considered for scheduling at the meeting; and

                (c)    inviting public submissions to be made by a date mentioned in the notice as the closing date for public submissions (the closing date).

         (2)   The closing date must be at least 4 weeks after publication of the Gazette notice.

         (3)   The date of the meeting must be at least a week after the closing date.

42ZCV   Consideration of public submissions

         (1)   The Committee, in making a decision in relation to the classification and scheduling of a substance, must consider all public submissions made by the closing date that address a matter mentioned in section 52E of the Act.

         (2)   The Committee need not consider a public submission made after the closing date.

42ZCW  Other matters to be considered by Committee

         (1)   A submission prepared in relation to a substance by a Committee member and submitted before or at the meeting about the scheduling of the substance must be considered by the Committee at the meeting.

         (2)   The Committee must also take into account any recommendation of a subcommittee about the substance.

42ZCX   Record of reasons for scheduling decisions

                The Committee must make a record of the reasons for a scheduling decision.

Note   Regulation 42ZCS provides that the Committee must keep a record of its proceedings.

42ZCY   Public notice of amendment

         (1)   A notice under subsection 52D (4) of the Act must include:

                (a)    an indication of the amendment; and

               (b)    instruction on how the record of the reasons for the amendment may be accessed; and

                (c)    an invitation to persons who made a public submission in relation to the substance the subject of the amendment to make a further submission.

         (2)   An amendment must not be expressed to come into force earlier than 4 weeks after publication of the notice.

         (3)   Nothing in subregulation (1) requires the Committee to disclose in the notice, or to provide access to, information that it properly regards as requiring confidentiality for commercial reasons.

42ZCZ    Further public submissions

         (1)   A submission in response to an invitation mentioned in paragraph 42ZCY (1) (c) must be made within 2 weeks after publication of the notice making the invitation.

         (2)   The submission must:

                (a)    address a matter mentioned in section 52E of the Act; and

               (b)    be relevant to the reasons recorded for making the amendment.

         (3)   If a submission is made to the Committee under this regulation, the Committee must consider the submission and then:

                (a)    confirm the amendment; or

               (b)    vary the amendment; or

                (c)    set aside the amendment, replace it with a new scheduling decision and publish notice of the decision under section 52D of the Act.

42ZCZA Public consultation by subcommittee

         (1)   The Committee may assign its public consultation responsibilities and functions under this Subdivision to a subcommittee.

         (2)   The subcommittee must give the Committee a written report setting out the manner of its compliance with those responsibilities and functions.

Note   Regulation 42ZCB deals with subcommittees.

42ZCZB Urgent scheduling

         (1)   This regulation applies if the Chair of the Committee considers that, in the interests of public health and safety, urgent scheduling of a substance is necessary.

         (2)   If it is not practicable to follow the procedures for public consultation prescribed by this Subdivision before scheduling, the Committee may make a scheduling decision without following the procedures.

         (3)   A scheduling decision made without following the procedures must be reviewed by the Committee as soon as practicable.

         (4)   The procedures for public consultation prescribed by this Subdivision apply to the review as if the review were a scheduling meeting.


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 No. 62.

2.       Made by the Governor-General on 9 September 1999, and notified in the Commonwealth of Australia Gazette on 16 September 1999