Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021 (Cth)

Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021

I, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following order.

Dated 24 September 2021

Adjunct Professor John Skerritt Deputy Secretary Health Products Regulation Group Department of Health

Contents Part 1Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions 5 Standard 6 Application 7 Transitional arrangements Part 2Labelling requirements 8 General requirements 9 Labels of HCT materials 10 Labels of biologicals Schedule 1—Labels in relation to HCT materials Schedule 2—Labels in relation to biologicals Part 1—Information on or attached to containers and primary packs Part 2—Information on, attached to, or supplied with containers or primary packs

Part 1Preliminary

1 Name (1) This instrument is the Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021. (2) This instrument may also be cited as TGO 107.

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 30 September 2021. 30 September 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Note: This table relates only to the provisions of this instrument as originally made.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. (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.