Health Act 1911

Health (Notification of Adverse Event After Immunization) Regulations 1995

 

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 practitioner1

5.Fee for notification2

6.Executive Director, Public Health may request provision of information3

Notes

Compilation table4

Provisions that have not come into operation4

Defined terms

 

Health Act 1911

Health (Notification of Adverse Event After Immunization) Regulations 1995

1.Citation

These regulations may be cited as the Health (Notification of Adverse Event After Immunization) Regulations 1995 1.

2.Interpretation

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.

5.Fee for notification

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 is a compilation 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 1a. The table also contains information about any reprint.

Compilation table

Citation

Gazettal

Commencement

Health (Notification of Adverse Event After Immunization) Regulations 1995

14 Nov 1995 p. 5287‑9

14 Nov 1995

Health (Notification of Adverse Event After Immunization) Amendment Regulations 2000

8 Aug 2000 p. 4549

8 Aug 2000

Reprint 1: The Health (Notification of Adverse Event After Immunization) Regulations 1995 as at 5 Mar 2004 (includes amendments listed above)

1aOn the date as at which this compilation was prepared, provisions referred to in the following table had not come into operation and were therefore not included in this compilation. For the text of the provisions see the endnotes referred to in the table.

Provisions that have not come into operation

Citation

Gazettal

Commencement

Health Regulations Amendment (Public Health) Regulations 2016 Pt. 14 2

10 Jan 2017 p. 237‑308

24 Jan 2017 (see r. 2(b) and Gazette 10 Jan 2017 p. 165)

2On the date as at which this compilation was prepared, the Health Regulations Amendment (Public Health) Regulations 2016 Pt. 14 had not come into operation. It reads as follows:

 

Part 14  Health (Notification of Adverse Event After Immunization) Regulations 1995 amended

49.Regulations amended

This Part amends the Health (Notification of Adverse Event After Immunization) Regulations 1995.

50.Regulation 4 amended

(1)In regulation 4(1) delete “Executive Director, Public Health” and insert:

 

Chief Health Officer

 

(2)In regulation 4(2)(a) delete “Executive Director, Public Health; and” and insert:

 

Chief Health Officer; and

 

51.Regulation 6 amended

In regulation 6(1):

(a)delete “Executive Director, Public Health —” and insert:

 

Chief Health Officer —

 

(b)delete “Executive Director, Public Health” (each occurrence) and insert:

 

Chief Health Officer

 

Note:The heading to amended regulation 6 is to read:

Chief Health Officer may request provision of information

 

 

 

Defined terms

 

[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]

Defined termProvision(s)

adverse event after immunization2