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Therapeutic Goods (Adverse Events Management System - Adverse Events Following Immunisation) (Arrangement for Computer Programs) Instrument 2022

Published

I, Nick Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following instrument.

Dated 3 November

Nick Henderson
Acting First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

1 Name

This instrument is the Therapeutic Goods (Adverse Events Management System—Adverse Events Following Immunisation) (Arrangement for Computer Programs) Instrument 2022.

2 Commencement

  1. Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument The day after this instrument is made. 4 November 2022

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

  1. Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) Secretary;
(b) therapeutic goods.

In this instrument:

Act means the Therapeutic Goods Act 1989.

adverse event means an adverse event that occurs in relation to a person in Australia following immunisation with a vaccine.

Note: An adverse event may not necessarily have a causal relationship with the administration of the vaccine.

AEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration.

SAEFVIC means the Surveillance of Adverse Events Following Vaccination In the Community, funded by the Department of Health, Victoria.

Note: SAEFVIC is comprised of two units at the following sites:
(a) Murdoch Children’s Research Institute (Clinical); and
(b) Monash Health & University (Epidemiology and Signal Investigation).

Therapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.

therapeutic goods information has the meaning given by subsection 61(1) of the Act.

5 Arrangement for computer programs

For subsection 7C(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the use of the computer program mentioned in column 2, is arranged for the purposes mentioned in column 3.

Schedule 1 - Arrangement for computer programs

Note: See section 5.

Arrangement for use of computer programs to make decisions
Column 1 Column 2 Column 3
Item Computer program Purposes
1 AEMS

any purposes in relation to the making of decisions under paragraph 61(3)(a) of the Act to release the following therapeutic goods information to an authority of a state or territory (the relevant state or territory) that has functions relating to therapeutic goods:

  1. carrying out an assessment under subsection 41FDB(1) of the Act as to whether the requirements set out in subsection 41FDB(2) of the Act have been met;

where:

  1. the AEMS report originated within the relevant state or territory; or
  2. the person who is reported to have suffered the adverse event (the relevant person) resided in the relevant state or territory; or
  3. the relevant person was vaccinated in the relevant state or territory; or
  4. the AEMS report does not specify the state or territory from which the AEMS report originated, where the relevant person resided, or where the relevant person was vaccinated
2 AEMS

any purposes in relation to the making of decisions under subsection 61(5AA) of the Act to release the following therapeutic goods information to SAEFVIC in accordance with the Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022:

  1. information about adverse events following immunisation with vaccines that is case details in relation to an individual AEMS report

Note 1: The Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022 is a legislative instrument made under subsection 61(5AB) of the Act and may be accessed at www.legislation.gov.au.

Note 2: Under subsection 61(5AA) of the Act, the Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.

 

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