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I, John Skerritt, as the appropriate authority, grant the following labelling exemption.
Dated 3 August 2022
Adjunct Professor John Skerritt
Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care
Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021
1 Name
This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) 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. | 4 August 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Note: This table relates only to the provisions of this instrument as originally made.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) medicine;
(c) Register;
(d) 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 medicine, and that:
- contain remdesivir as the only active ingredient; and
- have an indication accepted in relation to their inclusion in the Register that relates to the treatment of coronavirus disease 2019 (COVID-19); and
- are manufactured, imported or supplied by Gilead Sciences Pty Ltd.
5 Exemption
The specified products are exempt from the labelling requirements in:
- section 1.3(1)(a) of Part 2 of the current Poisons Standard; and
- section 1.3(1)(c) 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:
- labelling of the primary pack and immediate container with signal words, as required by section 1.3(1)(a);
- 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).
6 Repeals
Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Repeals
Note: See section 6.
Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021
1 The whole of the instrument
Repeal the instrument.