Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 (Cth)

Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021

I, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following order. Dated 24 March 2021

Dr Jane Cook First Assistant Secretary Medicines Regulation Division Health Products Regulation Group Department of Health

Contents Part 1—Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions 5 Standard 6 Application Part 2—Requirements 7 General requirements 8 Application of a data matrix code 9 Formatting etc. of a data matrix code 10 Information in a data matrix code

Part 1—Preliminary

1 Name (1) This instrument is the Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021. (2) This instrument may also be cited as TGO 106.

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 1 January 2023. 1 January 2023

Note: This table relates only to the provisions of this instrument as originally made.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

3 Authority This instrument is made under section 10 of the Therapeutic Goods Act 1989.

4 Definitions Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) batch; (b) container; (c) export only medicine; (d) label; (e) medicine; (f) primary pack; (g) product information; (h) standard. In this instrument: Act means the Therapeutic Goods Act 1989. Barcode Specifications means the document titled Barcode specifications for blood and blood products funded under the National Blood Arrangements published by the National Blood Authority (5 September 2014), as in force or existing at the commencement of this instrument. Note: This document is available on the internet at www.blood.gov.au. data matrix code means a two-dimensional arrangement of data consisting of blocks or dots in a square or rectangular pattern but does not include a QR code. GS1 means the not-for-profit standards organisation known as GS1 that has its headquarters in Belgium. GS1 General Specifications means the standard titled GS1 General Specifications published by GS1, as in force from time to time. Note: This standard is available on the internet at www.gs1.org. GTIN, or Global Trade Item Number, means the GS1 identification key used to identify trade items as defined in the GS1 General Specifications. Note: A GTIN comprises a GS1 company prefix, an item reference and check digit. national blood arrangements has the same meaning as in the National Blood Authority Act 2003. Regulations means the Therapeutic Goods Regulations 1990. relevant level of packaging, in relation to a medicine, means one of the following: (a) the primary pack; (b) the container; (c) single unit packaging within a container. Note 1: Primary pack is defined in subsection 3(1) of the Act as meaning the complete pack in which the goods, or the goods and their container, are to be supplied to consumers. Note 2: Container is defined in subsection 3(1) of the Act as meaning the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion. Note 3 Single unit packaging within a container includes an individual segment of a strip or blister pack, which immediately covers a single dosage unit, and which can be readily detached. serialisation, in relation to a medicine, means the unique identification of each unit of the medicine in a batch, at a relevant level of packaging. Note: Other grammatical forms of the word serialisation (such as serialised) have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901). serial number means a number that uniquely identifies a unit of a medicine.