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I, John Skerritt, as the appropriate authority, grant the following labelling exemption.
Dated 31 August 2022
Adjunct Professor John Skerritt
Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care
Contents
1 Name
This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.
2 Commencement
- 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.
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. | 1 September 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Note: This table relates only to the provisions of this instrument as originally made.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.
- 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 labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
4 Definitions
Note 1: A number of expressions used in this labelling exemption are defined in subsection 3(1) of the Act, including the following:
(a) current Poisons Standard;
(b) Register;
(c) registered goods.
Note 2: A number of expressions used in this labelling exemption are defined in section 1 of Part 1 of the current Poisons Standard, including the following:
(a) appropriate authority.
In this instrument:
Act means the Therapeutic Goods Act 1989.
specified products means registered goods that are vaccines, and that:
- contain the active ingredients elasomeran and imelasomeran in combination; and
- have an indication accepted in relation to their inclusion in the Register that relates to the prevention of coronavirus disease 2019 (COVID-19); and
- are manufactured, imported or supplied by Moderna Australia Pty Ltd.
5 Exemption
The specified products are exempt from the labelling requirements in:
(a) section 1.3(1)(a) of Part 2 of the current Poisons Standard; and
(b) section 1.3(1)(c) of Part 2 of the current Poisons Standard; and
(c) section 1.3(1)(k) of Part 2 of the current Poisons Standard; and
(d) section 1.4(1)(a) of Part 2 of the current Poisons Standard.
Note 1: Under section 1.1(1) of Part 2 of the current Poisons Standard, a scheduled substance or preparation must not be supplied unless labelled in accordance with section 1 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 section 1 of Part 2 of the current Poisons Standard:
(a) labelling of the primary pack and immediate container with signal words, as required by section 1.3(1)(a);
(b) labelling of the primary pack and immediate container with the cautionary statement 'KEEP OUT OF REACH OF CHILDREN', as required by section 1.3(1)(c);
(c) labelling of the primary pack and immediate container with the approved name and a statement of the quantity, proportion or strength, as required by sections 1.3(1)(k) and 1.4(1)(a).