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


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
  1. 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

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

Source link