Therapeutic Goods Regulations (Amendment) (Cth)

 

Statutory Rules 1991 No. 4851

Therapeutic Goods Regulations 2 (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 24 December 1991.

BILL HAYDEN

Governor-General

By His Excellency’s Command,

1. Amendment

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

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

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2. Regulation 2 (Interpretation)

2.1 Insert in regulation 2:

“‘ethics committee’ means a committee constituted and operating as an ethics committee in accordance with guidelines issued by the National Health and Medical Research Council as in force from time to time;”.

3. New regulations 12a and 12b

3.1 After regulation 12, insert:

Unapproved drugs—exemption in life-threatening cases

“12a. (1) For the purposes of subsection 18 (1) of the Act, all drugs, other than drugs of a class or kind listed in the 9th Schedule to the Poisons Standard, as in force from time to time, are exempted, subject to subregulation (2), from the operation of Part 3 of the Act.

“(2) The exemption of a drug is subject to the following conditions:

(a) the drug is to be given to a person who satisfies the following criteria:

(i) the person is a Category A patient (as defined in subregulation (5)); and

(ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the drug being given to the person; and

(iii) the medical practitioner by whom, or at whose direction, the drug is to be given to the person has signed a statement in relation to the person in the form approved by the Secretary for the purposes of this paragraph; and

(b) the drug is dispensed on the prescription of a medical practitioner who has prescribed the drug in accordance with good medical practice.

“(3) A person who signs a statement referred to in subparagraph (2) (a) (iii) must send a copy of the statement to the Secretary within 4 weeks of signing it.

Maximum penalty: $1,000.

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“(4) This regulation does not affect the operation of regulation 12.

“(5) In this regulation:

‘Category A patient’ means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment;

‘informed consent’,in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.

Exemptions for special and experimental uses

“12b. (1) For the purposes of paragraph 19 (6) (a) of the Act, each of the following classes of medical practitioners is prescribed in relation to drugs:

(a) medical practitioners, each of whom:

(i) is engaged in clinical practice at a hospital; and

(ii) is endorsed by the ethics committee of the hospital for the purposes of that paragraph;

(b) medical practitioners, each of whom:

(i) has specialist qualifications; and

(ii) is endorsed by a relevant specialist medical college or specialist medical society for the purposes of that paragraph;

(c) medical practitioners, each of whom:

(i) is engaged in general practice; and

(ii) is endorsed by a relevant specialist medical college or specialist medical society for the purposes of that paragraph;

if the college or society recognises that:

(iii) the practitioner has particular expertise in treating the relevant condition or conditions; or

(iv) the practitioner works in a remote locality where medical specialists are not available, or not readily available, to fulfil the need in the locality for supplying specified therapeutic goods or specified classes of therapeutic goods.

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“(2) The class of recipients prescribed for the purposes of paragraph 19 (6) (b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life-threatening, or otherwise serious, illness or condition.

“(3) For the purposes of subsection 19 (7) of the Act, the prescribed circumstances in which a drug, or a class of drugs, may be supplied in accordance with an authority under subsection 19 (5) of the Act are that the supplier of the drug or class of drugs complies with the treatment directions (if any) mentioned in the authority for the drug or class of drug.

“(4) For the purposes of subsection 19 (7) of the Act, the prescribed circumstances in which a therapeutic device, or a class of therapeutic devices, may be supplied in accordance with an authority under subsection 19 (5) of the Act are:

(a) that the medical practitioner whom the Secretary authorises under subsection 19 (5):

(i) is a specialist in clinical practice at a hospital; and

(ii) is endorsed by the relevant ethics committee of the hospital or a relevant specialist medical college or specialist medical society for the purposes of that subsection; and

(b) that the authority states the particular therapeutic intervention, or class of therapeutic intervention, for which the authorised person may supply the therapeutic device or class of therapeutic devices.”.

4. Regulation 35 (Therapeutic Device Evaluation Committee)

4.1 Subregulations 35 (2) and (3):

Omit the subregulations, substitute:

“(2) The functions of the Committee are:

(a) to give advice to the Minister or the Secretary in respect of:

(i) the safety, quality, efficacy, manufacture, use and availability of therapeutic devices:

(a) imported, or to be imported, into Australia; or

(b) to be exported from Australia; or

(c) supplied within Australia; and

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(ii) the priorities, policies and procedures that should be applied to the administration of the Act and these Regulations in relation to therapeutic devices; and

(iii) matters raised by sponsors or other persons about decisions or actions in relation to:

(a) the supply, use or modification of therapeutic devices; or

(b) information provided on therapeutic devices; and

(iv) drugs, to the extent that matters referred to in subparagraph (i), (ii) or (iii) are involved; and

(b) to give advice to other persons or bodies, in accordance with a direction in writing of the Minister, in relation to matters on which the Committee has given advice under paragraph (a).

“(3) Subject to subregulation (3a), the Committee consists of at least 6, and not more than 9, persons appointed in writing by the Minister from persons each of whom is eminent in his or her profession and has qualifications and expertise in one or more fields relevant to the functions of the Committee.

“(3a) In making appointments to the Committee, the Minister:

(a) must ensure that at least 4 members are medical practitioners; and

(b) must not appoint a person with expertise in a particular field if there are already 2 members who have expertise in that field.”.

5. Regulation 36(Australian Drug Evaluation Committee)

5.1 Subregulations 36 (3) and (4):

Omit the subregulations, substitute:

“(3) Membership of the Committee consists of:

(a) 6 or 7 core members; and

(b) at least 10, and not more than 20, associate members.

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“(4) The Minister must appoint to the Committee:

(a) as core members:

(i) at least 3 persons, each of whom is a medical practitioner eminent in the medical profession and at least 2 of whom are specialists in clinical medicine; and

(ii) at least 1 person who is a pharmacologist, or who holds a university degree in science or a branch of science and has specialised in pharmaceutical science; and

(b) as associate members:

(i) at least 1 person who is a pharmaceutical chemist with recent experience in the manufacturing of therapeutic goods; and

(ii) at least 1 person who is a toxicologist; and

(iii) at least 1 person who is a medical practitioner currently engaged in general practice; and

(iv) other persons, each of whom:

(a) satisfies a criterion set out in subparagraph (i), (ii) or (iii); or

(b) is a medical practitioner with specialist qualifications and experience in a field of medicine that complements the expertise of core members with medical qualifications.”.

6.Regulation 38 (Tenure of office of members)

6.1 Subregulations 38 (1) and (2):

Omit the subregulations, substitute:

“(1) Subject to subregulation (3), a member of a Committee established under this Part, other than the Australian Drug Evaluation Committee, holds office for a term not exceeding 3 years.

“(1a) Subject to subregulation (3):

(a) a core member of the Australian Drug Evaluation Committee holds office for a term not exceeding 3 years; and

(b) an associate member of that Committee holds office for a term not exceeding 5 years.

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“(2) Subject to subregulation (2a), a member of a Committee established under this Part is eligible for re-appointment.

“(2a) A person is not eligible to serve as a core member of the Australian Drug Evaluation Committee:

(a) for more than 3 consecutive terms; or

(b) for more than 5 terms in all.”.

7. Regulation 41 (Meetings of Committees)

7.1 Paragraph (2) (b):

Omit the paragraph, substitute:

“(b) in the case of the Australian Drug Evaluation Committee— 6 members, of whom at least 3 are core members, constitute a quorum; and”.

7.2 After subregulation (2), insert:

“(2a) An associate member of the Australian Drug Evaluation Committee is eligible to attend a meeting of the Committee only at the invitation of the chairperson of the Committee.

“(2b) The Australian Drug Evaluation Committee may delegate to the chairperson of the Committee any function of the Committee.

“(2c) The Therapeutic Device Evaluation Committee may delegate to the chairperson of the Committee any function of the Committee.”.

8. Regulation 45 (Waiver or reduction of fees)

8.1 Add at the end:

“(4) The Secretary may waive or reduce the evaluation fees set out in Schedule 9 that are payable on an application:

(a) to register therapeutic goods; or

(b) to modify or vary written information relating to a registered drug;

if the Secretary has information relating to the goods or drug, as the case may be, that allows the evaluation to be abridged.”.

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9. Regulation 47 (Delegation)

9.1 Omit the regulation, substitute:

Delegation—powers and functions under these Regulations

“47. (1) The Secretary may delegate to an officer of the Department a power or function of the Secretary under these Regulations.

“(2) The delegation must be by instrument signed by the Secretary.

Delegation—powers under paragraph 19 (1) (a) of the Act

“47a. (1) In this regulation, ‘delegation’ means a delegation, under subsection 57 (3) of the Act, of powers of the Secretary under paragraph 19 (1) (a) of the Act, that relates to specified therapeutic goods.

“(2) A delegation may only be to a person who:

(a) is a medical practitioner registered in a State or Territory and employed by an institution that has an ethics committee; and

(b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57 (3) of the Act.

“(3) If:

(a) a person proposes another person under paragraph (2) (b) as a person to be a delegate; and

(b) that other person becomes a delegate;

the first-mentioned person must supervise each approval that the delegate grants under the delegation.

“(4) A delegation must describe the person or class of persons to be treated with the therapeutic goods to which the delegation relates.

“(5) A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to:

(a) a particular item of therapeutic goods; or

(b) a particular class of therapeutic goods;

for treating a specific illness or condition.

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“(6) A delegate may grant an approval under a delegation only if:

(a) a medical practitioner other than the delegate has stated in writing that the person to be treated with the item of therapeutic goods to which the approval relates has an illness or condition that requires treatment with the item; and

(b) an ethics committee has agreed to the granting of approval under paragraph 19 (1) (a) of the Act for the use, in the circumstances in which the delegate grants the approval, of the item of therapeutic goods to which the delegation relates.

Provision of information concerning drugs and therapeutic devices

“47b. (1) A person who is:

(a) a delegate under subsection 57 (3) of the Act; or

(b) a person authorised under subsection 19 (5) of the Act by the Secretary to supply a drug or therapeutic device;

must provide a report to the Secretary every 3 months in accordance with subregulation (2).

“(2) A report must:

(a) be made in a form approved by the Secretary for the purposes of this regulation; and

(b) list each drug and therapeutic device approved by the person providing the report during the period to which the report relates; and

(c) state the number of new approvals, and the number of repeat approvals, of drugs and therapeutic devices that the person gave during that period.”.

10. Schedule 3 (Therapeutic goods required to be included in the Part of the register for registered goods)

10.1 Item 3:

Add at the end:

“(h) implantable breast prostheses”.

11. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

11.1 Item 1, paragraph (b):

After “injections”, insert “that contain material of human or animal origin”.

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12. Schedale 9 (Fees)
12.1 Item 4:
Omit subparagraphs (c) (i) and (ii), substitute:
“(i) not more than 10 pages	350
(ii) more than 10 pages but not more than 50 pages	2,900
(iii) more than 50 pages	6,400”.
12.2 Item 5:
Omit the item, substitute:
“5 evaluation fee for the purposes of subsection
24 (1) of the Act in respect of:
(i) a drug to which item 4 does not apply;	1,700
(ii) modifications to, or variations of, the written information relating to a drug included in the Register (other than a drug included in the Register in consequence of the payment of a fee specified in item 4)”.	350
12.3 Add at the end:
“15 data submitted for the evaluation of therapeutic devices requiring total evaluation time not exceeding half a day”.	350

NOTES

1. Notified in the Commonwealth of Australia Gazette on 24 December 1991.

2. Statutory Rules 1990 No. 394 as amended by 1991 No. 84.

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