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Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021

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This exemption has been repealed on the 4 August 2022. Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022 is the updated labelling exemption.

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

Dated 12 August 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 - GlaxoSmithKline) (Sotrovimab) 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 1Column 2Column 3
ProvisionsCommencementDate/Details
1. The whole of this instrumentThe day after this instrument is made.13 August 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Note: This table relates only to the provisions of this instrument as originally made.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.

  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

Note 1: A number of expressions used in this labelling exemption are defined in section 3 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 1 of the current Poisons Standard, including the following:
(a) appropriate authority.

In this instrument:

Act means the Therapeutic Goods Act 1989.

specified product means the medicine that:

  1. contains the active ingredient sotrovimab; 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 GlaxoSmithKline Australia Pty Ltd.

5 Exemption

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; and
  3. section 1.3(1)(k) of Part 2 of the current Poisons Standard; and
  4. 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).

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This webpage on the TGA website was printed on 21 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/news/notices/therapeutic-goods-poisons-standard-covid-19-treatment-glaxosmithkline-sotrovimab-labelling-exemption-2021

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