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Therapeutic Goods Amendment Regulations 2000 (No. 1)

Authoritative Version
  • - F2000B00035
  • No longer in force
SR 2000 No. 29 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 HR03-Apr-2000
Tabled Senate03-Apr-2000
Gazetted 23 Mar 2000
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2000 (No. 1) 2000 No. 29

EXPLANATORY STATEMENT

STATUTORY RULES No. 2000 NO. 29

Issued by the Authority of the Parliamentary Secretary to the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2000 (No. 1)

Subsection 63(1) of the Therapeutic Goods Act 1989 (the Act) provides that the GovernorGeneral may make regulations prescribing, among other things, matters necessary or convenient for carrying out or giving effect to the Act.

Paragraph 63(2)(a) provides that the regulations may make provision in relation to the establishment of committees to advise the Minister or the Secretary, on matters relating to therapeutic goods, and the functions and powers of those committees.

Paragraph 63(2)(h) provides that the regulations may prescribe fees in respect of matters under this Act or the regulations.

The purpose of the amendments to the Regulations is to.

*       Make minor amendments to existing regulations on the Complementary Medicines Evaluation Committee (CMEC) to improve the understanding of the application of the provisions (Items 2-6, 8-9);

*       Insert a new division in the Regulations which describes the functions of the Medicines Evaluation Committee and how the Committee will be constituted, hold meetings and make recommendations (Items 1 and 7). The new division will contain similar provisions to those already contained in the Regulations for CMEC;

*       Increase a range of fees payable for processing and evaluating different classes of medicines. The increases have been negotiated with industry and represent the amount required to enable the Therapeutic Goods Administration to fully recover its costs in performing the functions under the Act.

The amendments have been developed with the cooperation of the Proprietary Medicines Association of Australia and the Complementary Health Care Council of Australia.

Further details of the regulations are set out in the Attachment.

The regulations set out in Schedule 1 commence on gazettal, and the regulations set out in Schedule 2 commence on 31 March 2000.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS AMENDMENT REGULATIONS

Regulation 1 (Name of regulations)

This is a formal provision that specifies the title of the Regulations as the Therapeutic Goods Amendment Regulations 2000 (No. 1).

Regulation 2 (Commencement)

This provision provides that regulations 1 and 2 and subregulaton 3(1), and all the changes set out in Schedule 1 relating to fees, will commence on gazettal. Subregulation 3(2) and the changes set out in Schedule 2 will commence on 31 March 2000.

Regulation 3 (Amendment of Therapeutic Goods Regulations 1990)

This provision provides that Schedules 1 and 2. amend the Therapeutic Goods Regulations 1990. Schedule 1 sets out changes relating to fees, and Schedule 2 sets out amendments relating to two committees, the Complementary Medicines Evaluation Committee and the new Medicines Evaluation Committee

SCHEDULE 1 AMENDMENTS COMMENCING ON GAZETTAL

Item 1 amends the definition of "Poisons Standard" to reflect the new definition for that term in section 52A of the Act.

Items 2, 3 and 4 have the effect of replacing the current heading of Part 3A of the Regulations, and dividing Part 3A into 2 Divisions. Division 1 contains provisions that relate to the evaluation of goods mentioned in Part 1 of Schedule 10, which include mainly prescription medicines. Division 2 sets out the provisions relating to the evaluation of substances that are not related to either the inclusion of the substances in the Australian Register of Therapeutic Goods (the Register), or the variation of information contained in the Register about those substances.

Item 4 also inserts a new Regulation 16GA to enable fees to be charged for the evaluation of substances in certain circumstances, One circumstance is where a substance is not an ingredient in any goods included in the Register, but is a substance that may be included in goods that are the subject of an application for registration or listing in the Register. The other circumstance is where a person lodges an application for the evaluation of a new excipient used in therapeutic goods for dermal use, being an excipient that, at the time of registration or listing of the goods, was not included as an ingredient in any goods included in the Register for supply in Australia. However, the new evaluation fee payable for the evaluation of excipients, as described above, will not have to be paid if the evaluation is required as a result of complying with a condition imposed by the Secretary under section 28 of the Act before the commencement of this provision, and the application for evaluation is lodged, not later than 6 months from the date of registration or listing of the goods.

Items 5 and 10 clarify what application fees are payable for including in the Register the different classes of medicines. The effect of these changes is to move Item 4A of Schedule 9, relating to application fees for registering

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medicines evaluated by the Drug Safety and Evaluation Branch of the Department (mainly prescription medicines), back to Item 2 of Schedule 9 where all the other application fees for including goods in the Register are listed. The other change to Item 2 is to increase the application fee for registrable medicines not evaluated by the Drug Safety and Evaluation Branch of the Department, from $540 to 5650.

Item 6 makes a correction to Item 2(d) by deleting the reference to "paragraph (e)" which no longer is present in Schedule 9.

Item 7 increases the fee payable for varying information in the Register relating to registered medicines, other than medicines evaluated by the Drug Safety and Evaluation Branch of the Department (these are mainly prescription medicines).

Item 8 does not change the substance of Item 4 of Schedule 9, only its presentation. The amendment substitutes a reference to "goods evaluated by the Drug Safety and Evaluation Branch of the Department" with a reference to 'Tart 1 of Schedule 10% which is headed "Evaluation by the Drug Safety and Evaluation Branch of the Department",

Item 9 sets out the increases to the fees payable in respect of the evaluation of medicines referred to in Part 1 of Schedule 10, which are mainly prescription medicines.

Item 11 inserts new fees for the evaluation of registrable medicines that are not included under Pan 1 of Schedule 10. These fees relate to evaluations undertaken for the purposes of determining whether the goods may be entered into the Register, or for the purposes of amending information contained in the Register in relation to such goods. If the evaluation does not involve consideration of any clinical or toxicological information, the evaluation fee for this class of medicines will be increased to $4,300. Where the evaluation involves either clinical or toxicological information or both, the new fees payable are based on the number of pages that require evaluation.

Item 12 inserts 2 new Items into Schedule 9.

New Item 7A relates to fees for the evaluation of substances pursuant to paragraph 16GA(1)(a). The new fees are identical to the fees payable for evaluations undertaken to determine whether goods may be registered in the Register, or to amend information already in the Register about those goods.

New Item 7B sets out the new fees payable for evaluating substances included as new ingredients in therapeutic goods for dermal application, unless the fees am not required to be paid because of the operation of new subregulation 16GA(3).

SCHEDULE 2 AMENDMENTS COMMENCING ON 31 MARCH 2000

Part 1

Item 1 inserts a new definition of "OTC medicine" in Regulation 2.

Item 2 substitutes a new paragraph 42ZE(1)(d) to make it clear that therapeutic goods referred to CMEC for the purposes of this regulation by the Minister or Secretary are part of CMEC's evaluating function.

Item 3 amends paragraph 42ZF(2)(f) to clarify what may be included in CMEC's advice to the Minister or Secretary..

Item 4 amends subregulation 42ZQ(1) to require a member to make a disclosure of interests at or before a meeting of CMEC.

Item 5 substitutes a new subregulation 42ZQ(3) to make it clear that when CMEC is making a determination about a member who has made a disclosure of interests, the member, and any other member with an interest in the matter, must not be present or take part in making the determination. A member of a sub-committee under regulation 42ZG also has a duty of disclosure,

Item 6 amends regulation 42ZX to make it clear that at least half of the appointed members must be present to form a quorum.

Item 7 inserts into the Regulations a new Division, Division 5, which describes the functions, constitution and procedures for the Medicines Evaluation Committee.

Regulation 42ZZA (Definition)

This regulation provides definitions for the terms "Committee", "consultant physician" and "medical practitioner".

Regulation 42ZZB (Establishment and constitution of Committee)

This regulation establishes the Medicines Evaluation Committee with the functions, constitution and procedures set out in the Regulations.

Regulation 42ZZC (Committee's evaluating function)

This regulation describes the evaluating function of the Committee. The Committee may undertake evaluations and report to the Minister or Secretary about an OTC medicine, an ingredient or kind of ingredient in an OTC medicine, and therapeutic goods identified by the Committee or referred to the Committee by the Minister or the Secretary. The regulation further provides that the report of the Committee may include a recommendation as to whether a particular kind of therapeutic goods should be included in the Register as listed goods.

Regulation 42ZZD (Committee may give advice to Minister or Secret

Subregulation 42ZZD(1) provides that, in relation to the Committee's evaluating function, the Committee may provide scientific and policy advice to the Minister or Secretary about the import, export, registration, listing, manufacture, supply and use of the OTC medicine, ingredient, kind of ingredient or kind of therapeutic goods.

Subregulation 42ZZD(2) provides that the Committee may include in its advice its opinion about safety, quality, efficacy, indications, claims and

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information or evidence used to support a claim. The Committee may also include its assessment of short-term and long-term risks and claimed benefits of use.

Regulation 42ZZE (Committee may establish sub-committees)

This regulation provides that the Committee may appoint sub-committees to inquire into and report to the Committee on matters within the functions of the Committee. The subcommittees may consist of members of the Committee and other persons.

Regulation 42ZZF (Minister or Secretary may seek further advice)

This regulation provides that the Minister or the Secretary may give a copy of any advice provided to them by the Committee to another Committee and that Committee may make comments to the Minister or the Secretary about that advice.

Regulation 42ZZG (Committee may seek advice and assistance)

This regulation provides that the Committee may, in performing its functions, seek advice from other persons.

Regulation 42ZZH (Establishment and membership of Committee)

This regulation provides that the Committee is constituted in accordance with subdivision 4.

Regulation 42ZZI (Appointment of Committee members)

This regulation provides that the Minister must appoint members in writing in accordance with this regulation and that the Committee must include at least 8, but not more than 12 members.

Regulation 42ZZJ (Expertise and experience of members)

This regulation provides that in making appointments to the Committee the Minister must consider a person's expertise and experience in the listed fields.

Regulation 42ZZK (Appointment of Chair)

This regulation provides that the Minister must appoint a member of the Committee as its Chair.

Regulation 42ZZL (Minister may nominate expert advisers)

This regulation provides that the Minister may nominate expert advisers to assist the Committee in the performance of its functions. The Minister may nominate up to 8 persons as expert advisers and the Committee may ask these people for advice about the matters included within the Committee's functions. The regulations dealing with term of appointment, resignation, disclosure of interests and termination of appointment apply to a person nominated under this regulation

Regulation 42ZZM (Term of appointment)

The regulation provides that a Committee member is appointed for the term stated in the member's appointment and that term must not be greater than 3 years. However, a Committee member may be reappointed for further terms of up to 3 years each. The Chair of the Committee is also appointed for the term stated in the appointment and may be reappointed for further terms.

Regulation 42ZZN (Resignation)

This regulation provides that a member may resign by signed notice of resignation give to the Minister.

Regulation 42ZZO (Disclosure of interests)

This regulation addresses the situation where a matter is being considered, or is about to be considered, at a meeting and a Committee member is aware that he or she may have a direct or indirect pecuniary interest in the matter. The regulation provides that in such a case, the member must, without delay, disclose the nature of the interest at or before the matter. The disclosure must be recorded in the minutes of the meeting and the member must not be present during any deliberations on the matter nor take part in any decision of the Committee about the matter, unless the Committee should decide otherwise. For the purposes of determining whether the 'interested´ member may participate in any deliberation, or take pan in any decision, in the matter in which the Committee member has an interest, the Committee member, and any other Interested' member, must not be present during any deliberation on, or take part in deciding, this issue. A member of a sub-committee under regulation 42ZZE has a similar duty of disclosure.

Regulation 42ZZP (Termination of appointment)

This regulation describes the circumstances under which the Minister has a discretion to terminate a Committee member's appointment and those more serious circumstances under which the Minister must terminate an appointment.

Regulation 42ZZQ (Leave of absence)

The regulation provides that the Minister may grant leave of absence to the Chair of the Committee and the Chair may grant leave to any other member.

Regulation 42ZZR (Committee procedures)

This regulation provides that the procedures that the Committee must follow in holding meetings are set out in this subdivision.

Regulation 42ZZS (Committee procedures generally)

This regulation provides that the Committee must ad in accordance with the regulations with as little formality as possible, is not bound by the rules of evidence, may obtain information in any way it considers appropriate and may receive oral or written information or submissions. Further, the Committee must comply with any written directions of the Minister or the Secretary about the Committees performance of its functions.

Regulation 42ZZT (Meetings)

This regulation provides that the Chair may direct the committee to hold meetings at any time or place and to deal with matters in a particular manner, as stated in a written notice to the Committee. The regulation also provides that the Committee may decide the procedure for Committee meetings, subject to these regulations.

Regulation 42ZZU (Presiding member)

This regulation provides that the Chair must preside at a Committee meeting or nominate a member of the Committee to preside at the meeting. If the Chair is temporarily absent from a meeting, the member chosen by the members present must preside.

Regulation 42ZZV (Quorum)

This regulation provides that at a Committee meeting at least half of the appointed members must be present to form a quorum.

Regulation 42ZZW (Voting)

This regulation provides that a decision made by a majority of the votes of members present is a decision of the Committee and that the presiding member has a deliberative vote and also a casting vote should there be an equality of votes.

Regulation 42ZZX Records and reports)

This regulation provides that the Committee must keep a record of its proceedings and prepare any other report about its activities requested by the Minister or Secretary.

Item 8 replaces the heading to Part 3 of Schedule 10 with the current name of the area of the Department undertaking the evaluation.

Part 2 Additional amendments

Item 9 makes a number of minor amendments to regulations 42ZF and 42ZN to correct drafting errors and clarify the interpretation of these regulations.