I, John Skerritt, as the appropriate authority, grant the following labelling exemption.
Dated 15 October 2021
Adjunct Professor John Skerritt
Deputy Secretary
Health Products Regulation Group
Department of Health
Contents
1 Name
This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021.
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. | 16 October 2021 |
Note: This table relates only to the provisions of this instrument as originally made.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.
Note 2: A number of expressions used in this labelling exemption are defined in section 1 of Part of the current Poisons Standard, including the following:
(a) appropriate authority.
In this instrument:
Act means Therapeutic Goods Act 1989.
specified product means the vaccine that:
- contains the active ingredients casirivimab and imdevimab, in combination; and
- has an indication accepted in relation to its inclusion in the Register that relates to the treatment of coronavirus disease 2019 (COVID-19); and
- is manufactured, imported or supplied by Roche Products Pty Limited.
5 Exemption
The specified product is 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 product 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).