Health Act 1911
Health (Notification of Adverse Event After Immunization) Regulations 1995
Reprint 1: The regulations as at 5 March 2004
Guide for using this reprint
What the reprint includes
Endnotes, Compilation table, and Table of provisions that have not come into operation
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Notes amongst text (italicised and within square brackets)
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Notes of this kind may also be at the foot of Schedules or headings.
2.The other kind of editorial note shows something has been —
•removed (because it was repealed or deleted from the law); or
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The text of anything removed or omitted can be found in an earlier reprint (if there is one) or one of the written laws identified in the Compilation table.
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Health (Notification of Adverse Event After Immunization) Regulations 1995
CONTENTS
1.Citation1
2.Interpretation1
3.Adverse event after immunization prescribed as condition of health1
4.Notification by medical practitioner2
5.Fee for notification3
6.Executive Director, Public Health may request provision of information3
Notes
Compilation table4
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Reprinted under the Reprints Act 1984 as |
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at 5 March 2004 |
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Health Act 1911
Health (Notification of Adverse Event After Immunization) Regulations 1995
These regulations may be cited as the Health (Notification of Adverse Event After Immunization) Regulations 1995 1.
In these regulations —
“adverse event after immunization” means an event that —
(a)is of a kind listed in Appendix 7 of the National Health and Medical Research Council publication “The Australian Immunisation Handbook 7th Edition”; and
(b)occurs following the administration of a vaccine to a person.
[Regulation 2 amended in Gazette 8 Aug 2000 p. 4549.]
3.Adverse event after immunization prescribed as condition of health
An adverse event after immunization is prescribed as a condition of health to which Part IXA of the Act applies.
4.Notification by medical practitioner
(1)A medical practitioner must notify the Executive Director, Public Health of an adverse event after immunization within 14 days of becoming aware of that adverse event.
(2)A notification under subregulation (1) must —
(a)be in writing in a form approved by the Executive Director, Public Health; and
(b)include the following information —
(i)a full description of the adverse event after immunization;
(ii)the full name of the person who suffered the adverse event after immunization and that person’s address or telephone number;
(iii)where the adverse event after immunization is the death of a person, the full name, and the address or telephone number, of the next of kin or personal representative of the deceased person (if known);
(iv)the name, dose and batch number of the vaccine administered;
(v)the date on which the vaccine was administered;
(vi)the name and address of the place where the vaccine was administered; and
(vii)the full name, address and telephone number of the medical practitioner giving the notification.
(3)A medical practitioner who contravenes subregulation (1) commits an offence and is liable to a penalty which is not more than $1 000 and not less than —
(a)in the case of a first offence, $100;
(b)in the case of a second offence, $200; and
(c)in the case of a third or subsequent offence, $500.
A fee of $5 is payable to a medical practitioner who gives notification under regulation 4 but this regulation does not apply to a medical practitioner who is employed in the Public Service of the State or the Commonwealth, or is employed by an agency or instrumentality of the State or the Commonwealth.
6.Executive Director, Public Health may request provision of information
(1)Where the Executive Director, Public Health —
(a)is notified of an adverse event after immunization; and
(b)has reasonable grounds to believe that a person is able to provide information relating to the adverse event,
the Executive Director, Public Health may request the person to provide such information relating to the adverse event as the Executive Director, Public Health considers necessary for the purpose of achieving the objects of Part IXA of the Act.
(2)A person to whom a request is made under subregulation (1) must comply with the request within 14 days of receiving the request.
(3)A person who, without reasonable excuse, contravenes subregulation (2) commits an offence and is liable to a penalty which is not more than $1 000 and not less than —
(a)in the case of a first offence, $100;
(b)in the case of a second offence, $200; and
(c)in the case of a third or subsequent offence, $500.
Notes
1This reprint is a compilation as at 5 March 2004 of the Health (Notification of Adverse Event After Immunization) Regulations 1995 and includes the amendments made by the other written laws referred to in the following table. The table also contains information about any reprint.
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Citation |
Gazettal |
Commencement |
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Health (Notification of Adverse Event After Immunization) Regulations 1995 |
14 Nov 1995 p. 5287‑9 |
14 Nov 1995 |
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Health (Notification of Adverse Event After Immunization) Amendment Regulations 2000 |
8 Aug 2000 p. 4549 |
8 Aug 2000 |
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Reprint 1: The Health (Notification of Adverse Event After Immunization) Regulations 1995 as at 5 Mar 2004 (includes amendments listed above) |
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By Authority: JOHN A. STRIJK, Government Printer