Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022 (Cth)

Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022

I, Nick Henderson, as delegate of the Minister for Health and Aged Care, make the following specification.

Dated 24 February 2022

Nick Henderson First Assistant Secretary Medicines Regulation Division Health Products Regulation Group Department of Health

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Release of therapeutic goods information Schedule 1—Therapeutic goods information Part 1—NCIRS Part 2—SAEFVIC

1 Name This instrument is the Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 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 registered.

Note: This table relates only to the provisions of this instrument as originally made.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. (2) 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 61(5AB) 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. In this instrument: Act means the Therapeutic Goods Act 1989. AEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration. AIR means the Australian Immunisation Register established and kept under the Australian Immunisation Register Act 2015. NCIRS means the National Centre for Immunisation Research and Surveillance (ABN 53 188 579 090). 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.