Therapeutic Goods Amendment Regulations 1999 (No. 1) (Cth)

Therapeutic Goods Amendment Regulations 1999 (No. 1)

Statutory Rules 1999No. 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 theTherapeutic 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 1999No. 622

made under the

Therapeutic Goods Act 1989

   

Contents

Page

1. •
2. •

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1Name of regulations

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

2Commencement

 These regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(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 drughas 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 ofmedicine 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 4Complementary Medicines Evaluation Committee

Subdivision 1 Interpretation

42ZDDefinition

 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

42ZECommittee’s evaluating function

1. (1)

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

   1. (a)

      a complementary medicine;

   2. (b)

      an ingredient in a complementary medicine;

   3. (c)

      a kind of ingredient in a complementary medicine;

   4. (d)

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

2. (2)

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

   1. (a)

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

   2. (b)

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

   3. (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.

42ZFCommittee may give advice to Minister or Secretary

1. (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:

   1. (a)

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

   2. (b)

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

   3. (c)

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

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

1. (2)

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

   1. (a)

      the Committee’s opinion about its safety; and

   2. (b)

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

   3. (c)

      the Committee’s opinion about its quality; and

   4. (d)

      the Committee’s opinion about its efficacy; and

   5. (e)

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

   6. (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:

      1. (i)

         the Committee’s opinion about the claim; and

      2. (ii)

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

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

42ZGCommittee may establish sub-committees

1. (1)

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

2. (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.

42ZHMinister or Secretary may seek further advice

1. (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. (2)

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

42ZICommittee 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

42ZJEstablishment and membership of Committee

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

42ZKAppointment of Committee members

1. (1)

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

2. (2)

   An appointment of a member must be in writing.

3. (3)

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

42ZLExpertise and experience of members

1. (1)

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

   1. (a)

      complementary medicine practice;

   2. (b)

      consumer representation;

   3. (c)

      general medical practice;

   4. (d)

      herbal medicine;

   5. (e)

      naturopathy;

   6. (f)

      nutrition or nutritional medicine;

   7. (g)

      pharmacognosy;

   8. (h)

      pharmacology;

   9. (i)

      governmental regulation;

   10. (j)

       toxicology.

2. (2)

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

42ZMAppointment of Chair

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

42ZNMinister may nominate expert advisers

1. (1)

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

2. (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. (3)

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

4. (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;

1. (b)

   homoeopathy;

2. (c)

   Ayurvedic medicine;

3. (d)

   aromatherapy;

4. (e)

   regulatory affairs, in particular, scheduling of medicines;

5. (f)

   formulating, designing or manufacturing complementary medicines;

6. (g)

   consumer representation.

42ZOTerm of appointment

1. (1)

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

2. (2)

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

3. (3)

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

4. (4)

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

5. (5)

   The Chair may be reappointed for further terms.

42ZPResignation

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

42ZQDisclosure 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.

1. (2)

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

   1. (a)

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

   2. (b)

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

2. (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:

   1. (a)

      be present during any deliberation of the Committee about the determination; or

   2. (b)

      take part in making the determination.

42ZRTermination of appointment

1. (1)

   The Minister may terminate a Committee member’s appointment on the grounds of:

   1. (a)

      physical or mental incapacity; or

   2. (b)

      misbehaviour; or

   3. (c)

      incompetence; or

   4. (d)

      inefficiency; or

   5. (e)

      failing to comply, either recklessly or intentionally, with regulation 42ZQ.

2. (2)

   The Minister must terminate the member’s appointment if the member:

   1. (a)

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

   2. (b)

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

42ZSLeave of absence

1. (1)

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

2. (2)

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

   Subdivision 4 Committee procedures

42ZTCommittee procedures

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

42ZUCommittee procedures generally

 (1) In performing its functions, the Committee:

1. (a)

   must act according to these regulations; and

2. (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

3. (c)

   is not bound by rules of evidence; and

4. (d)

   may obtain information about an issue in any way it considers appropriate; and

5. (e)

   may receive information or submissions orally or in writing.

1. (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.

42ZVMeetings

1. (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. (2)

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

42ZWPresiding member

1. (1)

   The Chair of the Committee must:

   1. (a)

      preside at a Committee meeting; or

   2. (b)

      nominate a member of the Committee to preside at the meeting.

2. (2)

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

42ZXQuorum

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

42ZYVoting

1. (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. (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.

42ZZRecords and reports

1. (1)

   The Committee must keep a record of its proceedings.

2. (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

1. (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 2Evaluation 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