Therapeutic Goods (Poisons Standard) (COVID-19 Treatment – Gilead) (Remdesivir) Labelling Exemption 2021

I, John Skerritt, as the appropriate authority, grant the following labelling exemption.

Dated 10 September 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 - Gilead) (Remdesivir) Labelling Exemption 2021.

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.	11 September 2021

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 labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

4 Definitions

In this instrument:

Act means the Therapeutic Goods Act 1989.

specified product means the medicine that:

1. contains the active ingredient remdesivir; and
2. has an indication accepted in relation to its inclusion in the Register that relates to the treatment of coronavirus disease 2019 (COVID-19); and
3. is manufactured, imported or supplied by Gilead Sciences Pty Ltd.

5 Exemption

1. The specified product is exempt from the labelling requirements in:
   1. section 1.3(1)(a) of Part 2 of the current Poisons Standard; and
   2. section 1.3(1)(c) of Part 2 of the current Poisons Standard.

Period of exemption

2. This exemption takes effect on the commencement of this instrument and ceases to have effect on 1o July 2022.