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Therapeutic Goods Amendment Regulations 1999 (No. 1)

Authoritative Version
  • - F1999B00062
  • No longer in force
SR 1999 No. 62 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 Senate20-Apr-1999
Tabled HR11-May-1999
Gazetted 16 Apr 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Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014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. 1)

Statutory Rules 1999    No. 62

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 15 April 1999.

WILLIAM DEANE
Governor-General

By His Excellency’s Command,

MICHAEL WOOLDRIDGE

Minister for Health and Aged Care

 


Therapeutic Goods Amendment Regulations 1999 (No. 1)1

Statutory Rules 1999    No. 622

made under the

 

 

 

Contents

                                                                                                                 Page

                        1     Name of regulations                                                       

                        2     Commencement                                                             

                        3     Amendment of Therapeutic Goods Regulations 1990        

Schedule 1       Amendments                                                              

 


Do not delete : Part placeholder

Do not delete : Division placeholder

1           Name of regulations

                     These regulations are the Therapeutic Goods Amendment Regulations 1999 (No. 1).

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)

Do not delete : Schedule Part placeholder

[1]         Regulation 2, definitions of drugs, poison, Poisons Standard

             omit

[2]         Regulation 2, definition of active ingredient

             substitute

active ingredient has the same meaning as in section 52F of the Act.

[3]         Regulation 2, definition of orphan drug

             substitute

orphan drug has the meaning given by regulation 16H.

[4]         Regulation 2

             insert

complementary medicines has the same meaning as in section 52F of the Act.

Complementary Medicines Evaluation Committee means the Committee established under subsection 52G (1) of the Act.

traditional use has the same meaning as in section 52F of the Act.

[5]        

Note   After regulation 2, insert the following note:

Note   Definitions of medicine and poison are in the Act (see subsection 3 (1)).

[6]         Regulation 5B, definitions of approval number, complementary medicine, complementary use, designated active ingredient, mainstream media and traditional use

             omit

[7]         Regulation 5B, definition of approved advertisement

             substitute

approved advertisement has the same meaning as in section 42B of the Act.

[8]         Regulation 5D

             omit

[9]         Regulation 5E

             omit

[10]      Paragraph 5L (1) (b)

             omit

                  regulation 5D

             insert

                  section 42C of the Act

[11]      Part 6, after Division 3

             insert

Division 4        Complementary Medicines Evaluation Committee

Subdivision 1   Interpretation

42ZD     Definition

                In this Division:

Committee means the Complementary Medicines Evaluation Committee.

Note   The Complementary Medicines Evaluation Committee is established by section 52G of the Act.

Subdivision 2   Functions of Committee

42ZE     Committee’s evaluating function

         (1)   The Committee may evaluate, and report to the Minister or Secretary about any of the following:

                (a)    a complementary medicine;

               (b)    an ingredient in a complementary medicine;

                (c)    a kind of ingredient in a complementary medicine;

               (d)    a therapeutic good specified by the Minister or the Secretary for this regulation.

         (2)   The matters to be included in a report include a recommendation about the following, as applicable:

                (a)    whether or not a complementary medicine should remain in the Register;

               (b)    whether or not a complementary medicine should be included in the Register;

                (c)    whether or not an ingredient or kind of ingredient should be included in Schedule 14, or mentioned in Schedule 4 as the therapeutically active ingredient in a preparation mentioned in item 3 of Part 1 of that Schedule.

42ZF      Committee may give advice to Minister or Secretary

         (1)   The Committee may, in relation to a thing mentioned in subregulation 42ZE (1), give the Minister or Secretary scientific and policy advice about the following matters, as applicable:

                (a)    the import or export of the complementary medicine, ingredient, kind of ingredient or therapeutic good;

               (b)    registration or listing of the complementary medicine, ingredient, kind of ingredient or therapeutic good;

                (c)    the manufacture, supply and use of the complementary medicine, ingredient, kind of ingredient or therapeutic good.

Note   For the definition of supply, see subsection 3 (1) of the Act.

         (2)   An advice given about a thing mentioned in subregulation (1) may include, as applicable:

                (a)    the Committee’s opinion about its safety; and

               (b)    an assessment of short-term and long-term risks and claimed benefits of its use; and

                (c)    the Committee’s opinion about its quality; and

               (d)    the Committee’s opinion about its efficacy; and

                (e)    if the advice is about a therapeutic good — the Committee’s opinion about the indications of the good; and

                (f)    if the advice is about a therapeutic good in relation to which a claim has been made to which subsection 28 (6) of the Act applies, the advice may also include:

                          (i)    the Committee’s opinion about the claim; and

                         (ii)    the Committee’s opinion about the amount, standard or type of information or evidence used to support a claim.

Note   For the definition of indications, see subsection 3 (1) of the Act.

42ZG     Committee may establish sub-committees

         (1)   The Committee may appoint sub-committees, consisting of members of the Committee and other persons.

         (2)   The function of a sub-committee is to inquire into, and report to the Committee on, any specified matter that is within the functions of the Committee.

42ZH     Minister or Secretary may seek further advice

         (1)   If the Committee gives advice, under this Division, to the Minister or the Secretary, the Minister or the Secretary may give a copy of that advice to another Committee established under Division 1 of this Part.

         (2)   A Committee to which a copy of an advice is given may make comments to the Minister or the Secretary about that advice.

42ZI       Committee may seek advice and assistance

                The Committee may, in performing its functions under this Division, seek advice from other persons.

Subdivision 3   Constitution of Committee

42ZJ      Establishment and membership of Committee

                The Complementary Medicines Evaluation Committee established under subsection 52G (1) of the Act is constituted in accordance with this Subdivision.

42ZK     Appointment of Committee members

         (1)   The Minister must appoint members of the Committee in accordance with this regulation.

         (2)   An appointment of a member must be in writing.

         (3)   The Committee must include at least 8, but no more than 12, members.

42ZL      Expertise and experience of members

         (1)   In appointing members, the Minister must take into account candidates’ expertise and experience in the following fields:

                (a)    complementary medicine practice;

               (b)    consumer representation;

                (c)    general medical practice;

               (d)    herbal medicine;

                (e)    naturopathy;

                (f)    nutrition or nutritional medicine;

               (g)    pharmacognosy;

               (h)    pharmacology;

                (i)    governmental regulation;

                (j)    toxicology.

         (2)   At least 4 members of the Committee must have professional clinical experience in a field mentioned in subregulation (1).

42ZM     Appointment of Chair

                The Minister must, in writing, appoint a member of the Committee to be its Chair.

42ZN     Minister may nominate expert advisers

         (1)   The Minister may nominate a person to give expert advice to the Committee to assist it in the performances of its functions.

         (2)   If the Minister nominates a person for this section, the Committee may ask that person for advice about performing a function of the Committee.

         (3)   No more than 8 persons may be nominated under this regulation.

         (4)   Regulations 42ZO, 42ZP, 42ZQ and 42ZR apply to a person nominated under this regulation as if he or she were a member of the Committee.

Example

In nominating a person for this regulation, the Minister may consider the person’s expertise and experience in any of the following areas:

    (a)     traditional Chinese medicine;

    (b)     homoeopathy;

     (c)     Ayurvedic medicine;

    (d)     aromatherapy;

     (e)     regulatory affairs, in particular, scheduling of medicines;

     (f)     formulating, designing or manufacturing complementary medicines;

     (g)     consumer representation.

42ZO     Term of appointment

         (1)   A Committee member is appointed for the term stated in the member’s appointment.

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

         (3)   However, a Committee member may be reappointed for further terms of up to 3 years each.

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

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

42ZP     Resignation

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

42ZQ     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 a 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)   For the purpose of making 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 Committee about the determination; or

               (b)    take part in making the determination.

42ZR     Termination of appointment

         (1)   The Minister may terminate a Committee member’s appointment 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 42ZQ.

         (2)   The Minister must terminate the member’s appointment 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.

42ZS     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.

Subdivision 4   Committee procedures

42ZT     Committee procedures

                For subsection 52G (3) of the Act, this Subdivision sets out the procedures that the Committee must follow in holding meetings.

42ZU     Committee procedures generally

         (1)   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; and

                (e)    may receive information or submissions orally or in writing.

         (2)   In addition, the Committee must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions.

42ZV     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)   Subject to these regulations, the procedure of a Committee’s meeting is as decided by the Committee.

42ZW    Presiding member

         (1)   The Chair of the Committee must:

                (a)    preside at a Committee meeting; or

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

         (2)   If the Chair is temporarily absent from a meeting, the member chosen by the members present must preside.

42ZX     Quorum

                At a Committee meeting, a quorum exists if half of the members are present.

42ZY     Voting

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

         (2)   The member presiding at a Committee meeting has a deliberative vote and, in the event of an equality of votes, also has a casting vote.

42ZZ      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.

[12]      Schedule 4, Part 1, paragraph 3 (f)

             omit

                  sold or otherwise distributed

             insert

                  supplied

[13]      Schedule 4, Part 1, subparagraph 3 (f) (i)

             substitute

                          (i)    in a form that contains the substance in excess of the maximum amount per dosage for that form, as mentioned in column 2 of the table in that Division; and

[14]      Schedule 4, Part 5, Division 2, Subdivision 1

             substitute

Subdivision 1   Interpretation

1.

A reference in column 2 of the table to a maximum amount per dosage form in relation to a substance mentioned in column 1 is a reference to the maximum amount of the substance that can be present in the particular dosage form mentioned in column 2 in relation to a preparation containing the substance.

2.

A reference in column 3 of the table to a maximum daily dose in relation to a substance mentioned in column 1 is a reference to the daily maximum intake of the substance, in all dosage forms containing the substance.

3.

A reference in this Division to a dosage form of a substance mentioned in column 1 of the table:

(a)      is a reference to the form in which a preparation containing the substance is sold, or otherwise distributed (for example, as a tablet or capsule); and

(b)      is not a reference to other chemical compounds in which the substance mentioned in column 3 may occur.

Example

For example, a preparation including chromium nicotinate (a substance mentioned in column 1 of the table) that contains 50 micrograms of chromium complies with the dosage limitation even though it also contains any of the mineral salts mentioned elsewhere in this Schedule.

[15]      Schedule 4, Part 5, Division 2, Subdivision 2, column 3 of table, heading

             omit

                  Maximum daily dose (all forms)

             insert

                  Maximum daily dose (all dosage forms)

[16]      Schedule 10, Part 2, heading

             substitute

Part 2          Evaluation by the Office of Complementary Medicines

[17]      Schedule 14, heading

             omit

                  (regulation 5B)

             insert

                  (Act, section 52F)

[18]      Additional amendments

 

provision

omit

insert

subregulation 9A (1)

drug

medicine

regulation 12A, heading

drugs

medicines

subregulation 12A (1) (occurring twice)

drugs

medicines

subregulation 12A (2) (occurring 6 times)

drug

medicine

subregulation 12B (1) (occurring 3 times)

drugs

medicines

subregulation 12B (3) (occurring 4 times)

drug

medicine

subregulation 12B (3) (occurring twice)

drugs

medicines

paragraph 15 (1) (b) (occurring twice)

drugs

medicines

Part 3A, heading

drugs

medicines

subregulation 16C (1)

drug

medicine

subregulation 16C (4) (occurring 3 times)

drug

medicine

subregulation 16D (1) (occurring twice)

drug

medicine

subregulation 16D (4) (occurring 3 times)

drug

medicine

subregulation 16F (1) (occurring twice)

drug

medicine

subregulation 16G (1) (occurring twice)

drug

medicine

subregulation 16H (1) (first occurring)

drug

medicine

subregulation 16H (3) (second occurring)

drug’s

medicine’s

subregulation 16I (1) (second occurring)

drug

medicine

subregulation 16I (3) (first occurring)

drug

medicine

subregulation 16J (2) (first occurring)

drug

medicine

subregulation 16J (3) (first occurring)

drug

medicine

subregulation 16J (4)

drug

medicine

subregulation 16J (5)

drug

medicine

paragraph 16J (5) (b)

drug’s

medicine’s

paragraph 16J (5) (c) (first occurring)

drug

medicine

subregulation 34 (4A) (occurring twice)

drug

medicine

subparagraph 35 (2) (a) (iv)

drugs

medicines

subregulation 36 (2) (occurring twice)

drugs

medicines

subregulation 45 (4) (occurring twice)

drug

medicine

paragraph 45 (12) (a) (first occurring)

drug

medicine

paragraph 46 (2) (e) (occurring twice)

drugs

medicines

regulation 47B, heading

drugs

medicines

subregulation 47B (1)

drug

medicine

paragraph 47B (2) (c)

drugs

medicines

Schedule 3, Part 1, heading

drugs

medicines

Schedule 3, Part 1, items 1 (first occurring), 2 (first occurring), 2A (first occurring) and 2B (first occurring)

drugs

medicines

Schedule 3, Part 1, paragraph 3 (f) and subparagraphs 3 (f) (i) and (g) (iv)

drug

medicine

Schedule 4, Part 1, items 8 and 12

drug

medicine

Schedule 4, Part 1, items 10, 11 and 12

drugs

medicines

Schedule 5, paragraph 1 (c), subparagraph 1 (c) (ii) (occurring twice) and items 6 (occurring twice), 8 and 9

drugs

medicines

Schedule 5, subparagraph 1 (c) (ii) (occurring twice)

drug

medicine

Schedule 5A, paragraph 7 (c) (occurring twice)

drug

medicine

Schedule 8, paragraph 1 (a)

drug

medicine

Schedule 9, paragraph 1 (b), paragraphs 2A (a), (b) and (c), item 4A, paragraph 5 (a) and paragraph 5 (b) (occurring twice) and item 14

drug

medicine

Schedule 9, subparagraph 1 (a) (i), paragraph 1 (b) (occurring twice) and paragraph 3 (b)

drugs

medicines

Schedule 10, Part 1, items 5 and 12

drug

medicine


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.

2.       Made by the Governor-General on 15 April 1999, and notified in the Commonwealth of Australia Gazette on 16 April 1999