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Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer) (SARS-CoV-2 Spike Protein (mRNA) LP.8.1) Labelling Exemption 2025

Published

I, Anthony Lawler, as an appropriate authority, make the following labelling exemption.

Dated 7 October 2025

Professor Anthony Lawler
Deputy Secretary
Health Products Regulation Group
Department of Health, Disability and Ageing

 

1 Name 

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer) (SARS-CoV-2 Spike Protein (mRNA) LP.8.1) Labelling Exemption 2025.

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. 

8 October 2025 

Note: This table relates only to the provisions of this instrument as orinally 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 section 39 of the current Poisons Standard. 

4 Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: 

  1. current Poisons Standard; 

  2. Register; 

  3. registered goods. 

Note 2:  A number of expressions used in this instrument are defined in section 6 of the current Poisons Standard, including the following: 

  1. appropriate authority. 

In this instrument: 

Act means the Therapeutic Goods Act 1989. 

specified products means registered goods that are vaccines, and that: 

  1. contain the active ingredient SARS-CoV-2 spike protein (mRNA) LP.8.1; and 

  2. have an indication accepted in relation to their inclusion in the Register that relates to the prevention of coronavirus disease 2019 (COVID-19); and 

  3. are manufactured in, imported into, or supplied in, Australia by Pfizer Australia Pty Ltd. 

5 Exemption 

The specified products are exempt from the labelling requirements in: 

  1. section 16 of the current Poisons Standard; and
  2. section 18 of the current Poisons Standard. 

Note 1: Under section 13 of the current Poisons Standard, a scheduled substance or preparation must not be supplied unless labelled in accordance with Division 2 of Part 2 of the current Poisons Standard. 

Note 2: Section 5 of this instrument exempts the specified products from the following labelling requirements in Division 2 of Part 2 of the current Poisons Standard: 

  1. labelling of the primary pack and intermediate container with signal words, as required by section 16; 

  2. labelling of the primary pack and intermediate container with the cautionary statement ‘KEEP OUT OF REACH OF CHILDREN’, as required by section 18. 

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