Commonwealth legislation

Therapeutic Goods (Excluded Goods) Determination 2018

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

7/10 complexity

This instrument designates specified products as “excluded goods” under section 7AA of the Therapeutic Goods Act 1989, listing goods in Schedule 1 and goods in Schedule 2 when used, advertised or presented in specified ways (s5–6). It affects manufacturers, importers, suppliers and advertisers by removing registration and other therapeutic‑goods obligations for those products where they meet composition, labelling, performance or use conditions (for example sunscreen standards, software intent limits, and biological‑material/professional‑supervision requirements). Suppliers bear compliance costs; the regulator sets scope by this instrument.

JSON API Health / NDIS / medicines

Deep Dive

5,540 words · generated 12/06/2026

What it does

This instrument, the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination), declares specified classes of goods to be "excluded goods for the purposes of the Act" under subsection 7AA(1) and 7AA(2) of the Therapeutic Goods Act 1989 (the Act). Mechanically, section 5 records that the goods listed in Schedule 1 are excluded goods for the purposes of the Act, and section 6 records that the goods listed in Schedule 2 are excluded goods when they are used, advertised or presented for supply in the particular ways specified in that Schedule. The instrument is made under the authority of section 7AA of the Act (see section 3).

The Determination operates by reference to the Act for defined terms (section 4 notes that a number of expressions, including advertise, label, medical device, medicine, Register, supply and therapeutic use, are defined in subsection 3(1) of the Act) and by cross-referencing external standards and instruments. Key external references included within the instrument itself are AS 2896-2011 (medical gas pipeline systems), AS/NZS 2604:2021 (sunscreen products , evaluation and classification), the Medical Devices Regulations (Therapeutic Goods (Medical Devices) Regulations 2002), the Poisons Standard (the instrument made under s 52D of the Act), and the Regulations (Therapeutic Goods Regulations 1990). Several Schedule items impose conditional tests that must be met for the exclusion to apply (for example, sunscreen-related items require specific labelling and performance requirements drawn from AS/NZS 2604:2021; software items are defined by intended use and exclusions where clinical use, diagnosis or therapeutic decision-making is intended).

The Determination contains transitional provisions (Part 7) preserving earlier exclusion treatment for certain goods covered by Schedule 1 items 14 and 15 and Schedule 2 items 5 and 10, but only where (a) the goods were excluded under those items on 30 June 2024, (b) paragraph (b) in column 2 of each of those items applied as in force immediately before the Therapeutic Goods (Excluded Goods) Amendment (Sunscreen) Determination 2024, and (c) the goods are imported, manufactured or supplied before 1 July 2029.

Current sections

Direct links to the current provisions in Therapeutic Goods (Excluded Goods) Determination 2018.

Name

1 Name

This instrument is the Therapeutic Goods (Excluded Goods) Determination 2018.

Authority

3 Authority

This instrument is made under section 7AA of the Therapeutic Goods Act 1989.

Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act including:

(a) advertise;
(b) label;
(c) medical device;
(d) medicine;
(e) Register;
(f) supply;
(g) therapeutic use.

In this instrument:

Act means the Therapeutic Goods Act 1989.

AS 2896–2011 means the document, Australian Standard: Medical gas systems – Installation and testing of non-flammable medical gas pipeline systems (AS 2896–2011), prepared by Committee HE-017 (Medical Gas Systems), approved on behalf of the Council of Standards Australia on 13 January 2011, and published by SAI Global Limited under licence from Standards Australia on 8 May 2011, as in force or existing immediately before the commencement of this instrument.

AS/NZS 2604:2021 means the document Australian/New Zealand Standard AS/NZS 2604:2021, Sunscreen products ‑ Evaluation and classification, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing on 1 July 2024.

haematopoietic progenitor cells has the meaning given by clause 1 of Part 1 of Schedule 9 to the Regulations.

health professional has the same meaning as in the Medical Devices Regulations.

Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

Poisons Standard means the legislative instrument made under section 52D of the Act, as in force immediately before the commencement of this instrument.

Regulations means the Therapeutic Goods Regulations 1990.

secondary sunscreen product has the same meaning as in AS/NZS 2604:2021.

serious, for a condition, ailment or defect, has the same meaning as in the Medical Devices Regulations.

serious disease has the same meaning as in the Medical Devices Regulations.

Excluded goods

5 Excluded goods

For subsection 7AA(1) of the Act, the goods specified in Schedule 1 are excluded goods for the purposes of the Act.

Excluded goods when used, advertised or presented for supply in a particular way

6 Excluded goods when used, advertised or presented for supply in a particular way

For subsection 7AA(2) of the Act, the goods specified in Schedule 2, when used, advertised, or presented for supply in a way specified in that Schedule are excluded goods for the purposes of the Act.

7 Application, saving and transitional provisions

Items 14 and 15 of the table in Schedule 1 and items 5 and 10 of the table in Schedule 2, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Sunscreen) Determination 2024, continue to apply to goods covered by those items only where: (a) the goods were excluded goods under those items on 30 June 2024; and (b) paragraph (b) in column 2 of each of those items, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Sunscreen) Determination 2024, applies to the goods; and (c) the goods are imported, manufactured or supplied before 1 July 2029.

Schedule 1 Specified goods

(section 5)

<table cellspacing="0" cellpadding="0" style="width:421.9pt; border-collapse:collapse"><thead><tr style="height:16.1pt"><td colspan="3" style="width:411.1pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td></tr><tr style="height:16.1pt"><td colspan="2" style="width:51.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 1</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Item</span></p></td><td style="width:349pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 2</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:44.25pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>1</span></p></td><td colspan="2" style="width:356.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>adhesive removers and non-medicated skin cleansers relating to colostomy and ileostomy</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>1A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>anatomical models that are intended by the manufacturer to be used for educational or record-keeping purposes</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="line-height:115%; font-size:10pt"><span>antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="line-height:115%; font-size:10pt"><span>articles that are non-sterile personal protective equipment or safety apparel other than articles specified in item 1 of Schedule 1 to the </span><span style="font-style:italic">Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>cosmetic finishing components for orthoses and prostheses</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>craniofacial prostheses that are:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>spectacle-retained; or</span></p><p style="margin-left:18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; display:inline-block"> </span><span>adhesive-retained</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>dental bleaches and dental whiteners</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3AA</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>dental impression trays</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>detergents and soaps for laundering or general cleaning use, other than detergents and soaps that are disinfectants within the meaning of the Regulations</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>4</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>devices for measuring alcohol content in body fluids or exhaled air</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>5</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>disinfectant and sterilant gases</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>6</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>drinking water purification and treatment equipment</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ear candles</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7AA</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ear moulds that are intended by the manufacturer to anchor hearing aids</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>fluoridated reticulated drinking water</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>8</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>hair bleaches, hair dyes, hair-colorants and hair-perming preparations</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>9</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>household and personal aids, or furniture and utensils, for people with disabilities</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>10</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>incontinence pads, mattress overlays and mattress protectors</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>10A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>medicament trays that are intended by the manufacturer to hold medicaments</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>menstrual pads other than tampons and menstrual cups</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>mouthguards intended by the manufacturer to be used to protect teeth from external forces including, but not limited to, mouthguards used in contact sports</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ocular prostheses intended by the manufacturer to be used for cosmetic purposes</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>physical impressions of anatomy, and models cast from such impressions</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>12</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>sanitation, environmental control and environmental detoxification equipment (including films and coatings), other than articles specified in item 3 of Schedule 1 to the </span><span style="font-style:italic">Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020</span></p><p class="notetext" style="margin-top:4pt; margin-left:39.9pt; text-indent:-39.9pt; font-size:10pt"><span>Note:</span><span style="width:17.68pt; text-indent:0pt; display:inline-block"> </span><span>Sanitation, environmental control and environmental detoxification equipment does not include disinfectants within the meaning of the Regulations.</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>12A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>spectacle frames</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>13</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>topical preparations applied to the nails to harden, or deter the biting of, nails</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>products containing sunscreen that are intended for application to the lips, and that:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>are a secondary sunscreen product; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>meet the performance requirements for a broad-spectrum product set out in clause 5.3 and Table</span><span> </span><span>1 in clause 4.2 of AS/NZS 2604:2021</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>in relation to a serious disease or serious condition, ailment or defect; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software, or a combination of software and non-invasive hardware, that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer to promote or facilitate general health or wellness by measuring or monitoring (through non-invasive means) a physical parameter, such as movement, sleep, heart rate, heart rhythm, temperature, blood pressure or oxygen saturation; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a serious disease or a serious condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer to improve general health or wellness by coaching, or encouraging behavioural change, in relation to personal or environmental factors, such as weight, exercise, sun exposure or dietary intake; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice or to provide information to the consumer that would generally be accepted to require the interpretation of a health professional; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, prognosis, or making a decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14D</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used as a patient reported outcome measures (PROMs) questionnaire or patient survey; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14E</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is a digital mental health tool (including a cognitive behaviour therapy tool) based on established clinical practice guidelines that are referenced and displayed in the software in a manner that is reviewable by the user</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14F</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services; and</span></p><p class="ListParagraph" style="text-indent:-18pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14G</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the administration or management of health processes or facilities (including financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions, inventory and workflow); and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14H</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14I</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the sole purpose of providing alerts to health professionals in relation to patient care; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>replace the clinical judgement of a health professional; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>diagnose, screen for, prevent, alleviate, treat, or make a decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14J</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for clinical workflow management; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14K</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is middleware and is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>control medical devices; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>perform analysis, computation or logic that relates to the intended purpose of a medical device; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14L</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is a calculator and:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>either:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>uses relevant published clinical standards or authoritative sources to make calculations; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>displays calculations and outputs in a manner that may be validated by the user; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>is not intended by its manufacturer to control the administration of a calculated dosage</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14M</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software, or a combination of software and hardware, that is an electronic health record (however named or described) and is:</span></p><p style="margin-top:3pt; margin-left:38.95pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:10.15pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used in clinical practice by healthcare providers to collect, use, disclose and otherwise manage patient clinical data within or between healthcare facilities; and</span></p><p style="margin-top:3pt; margin-left:38.95pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:9.59pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14N</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is data analytics and is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the collection and analysis of class, group or population data; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation, of a disease, condition, ailment or defect in relation to individuals</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14O</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is a laboratory information management system (however named or described) and is not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>manipulate information or data to change, or generate new, diagnostic outputs (other than automating simple calculations or generating report comments); or</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>prevent, monitor, predict, make a prognosis of, treat or alleviate a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>15</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span></span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>tinted bases and foundations, such as liquids, pastes or powders, that contain sunscreen, and that:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>are a secondary sunscreen product; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>meet the performance requirements for a broad-spectrum product set out in clause 5.3 and Table 1 in clause 4.2 of AS/NZS 2604:2021</span></p></td></tr><tr style="height:0pt"><td style="width:55.05pt"></td><td style="width:7.05pt"></td><td style="width:359.8pt"></td></tr></tbody></table>

Schedule 2 Specified goods used, advertised or presented for supply in a particular way

(section 6)

<table cellspacing="0" cellpadding="0" style="width:423.6pt; border-collapse:collapse"><thead><tr style="height:16.1pt"><td colspan="3" style="width:235.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td><td style="width:166.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold"></span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 1</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Item</span></p></td><td style="width:166.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 2</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td><td colspan="2" style="width:180.6pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 3</span></p><p style="margin-top:3pt; margin-right:1.7pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">When used, advertised or presented for supply in a particular way</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>1</span></p></td><td style="width:166.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-right:1.7pt; line-height:115%; font-size:10pt"><span>anti-acne skin care products, including spot treatments, cleansers, face scrubs and masks, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard</span></p></td><td colspan="2" style="width:180.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>when advertised or presented for supply as controlling or preventing acne only through cleansing, moisturising, exfoliating or drying the skin</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2</span></p></td><td style="width:166.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-right:1.7pt; line-height:115%; font-size:10pt"><span>antibacterial skin care products that do not</span><span> </span><span>contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard</span></p></td><td colspan="2" style="width:180.6pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>when advertised or presented for supply as being active against bacteria and not advertised or presented for supply as being:</span></p><ol class="awlist1" style="margin:0pt; padding-left:0pt"><li class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>active against viruses, fungi or other microbial organisms (other than bacteria); or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for use in connection with disease, disorders or medical conditions; or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>active against a named bacterium that is known to be associated with a disease, disorder or medical condition; or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for use in connection with piercing of the skin or mucous membrane, for cosmetic or any other purpose; or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:8.01pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for use before physical contact with a person who is accessing medical or health services, or who is undergoing any medical or health care procedure; or</span></li><li class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>for use in connection with a procedure involving venepuncture or delivery of an injection</span></li></ol></td></tr><tr style="height:0pt"><td style="width:55.05pt"></td><td style="width:177.15pt"></td><td style="width:14.2pt"></td><td style="width:177.2pt"></td></tr></tbody></table>

3	anti-dandruff hair care products	when advertised or presented for supply as controlling or preventing dandruff only through cleansing, moisturising, exfoliating or drying the scalp
4	compressed gases	when used as a power source for medical devices
4A	goods in relation to which the following paragraphs apply:(a) the goods comprise, contain or are derived from, human cells or human tissues collected from a patient (the relevant patient) who is under the clinical care of a medical or dental practitioner (the relevant practitioner);(b) the relevant practitioner is registered in a State or internal Territory;(c) subject to paragraph (d), all steps in the manufacture of the goods are carried out by, or under the professional supervision of, the relevant practitioner in a hospital in a State or internal Territory (the relevant hospital);(d) if a step in the manufacture of the goods relating to the storage or testing of the goods is not carried out in the relevant hospital, it is carried out by a person under contract with the relevant hospital	when the goods are:(a) used for the relevant patient, who is a patient of the relevant hospital; and(b) not advertised directly to consumers
4B	goods that are fresh viable human haematopoietic progenitor cells	when used for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution
4C	goods that are fresh viable human organs or parts of human organs	when used for direct donor-to-host transplantation
4D	goods that are human reproductive tissue	when used in assisted reproductive therapy
4E	goods that are:(a) human eggs; or(b) human sperm	when used in carrying out an activity as authorised or purportedly authorised by a mitochondrial donation licence under the Research Involving Human Embryos Act 2002
5	moisturising skin care products containing sunscreen that are intended for dermal application (including anti-wrinkle, anti-ageing and skin whitening products), and that:(a) do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and(b) are a secondary sunscreen product; and(c) have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and(d) if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604: 2021; and(e) meet the performance requirements for a broad‑spectrum product set out in clause 5.3 and Table 1 in clause 4.2 of AS/NZS 2604:2021	when the product:(a) is not advertised or presented for supply as having a sun protection factor of more than 15; and(b) is not advertised or presented for supply as being water-resistant; and(c) if the product is not stable for at least 36 months—includes an expiry date on its label; and(d) has a pack size not larger than 300 mL or 300 g; and(e) does not have any therapeutic claims made in relation to it (including claims about skin cancer), other than those in relation to premature ageing in connection with sun exposure
6	oral hygiene products for the care of the teeth and the mouth, including dentifrices, mouth washes and breath fresheners, that do not contain any substance included in Schedules 2, 3, 4 or 8 to Poisons Standard	when advertised or presented for supply, the following two paragraphs apply:the only benefits claimed to result from the use of the product is consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay; andbenefits in relation to such other diseases or aliments, such as gum or other oral disease or periodontal condition, are not claimed to result from use of the product
7	packs and kits containing medical devices for the prevention of blood borne and sexually transmissible diseases where each individual therapeutic good contained within the packs or kits is already included on the Register	when advertised or presented for supply as a part of a Government endorsed health promotion program, having been expressly authorised by that Government as part of that program
8	piped medical gas systems	when installed and used in compliance with AS 2896–2011
9	preparations containing a sunscreening substance, if the primary purpose of the preparation is neither protection from solar radiation nor another therapeutic purpose	when the preparation is not advertised or presented for supply with:a statement of claimed sun protection factor; ora description of a claimed sun protection factor; ora reference to another therapeutic use in respect of the preparation
10	sunbathing skin care products that contain sunscreen (such as oils, creams, gels, tanning products without sun, and after-sun care products), and that:(a) have a sun protection factor of at least 4 and not more than 15; and(b) do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and(c) are a secondary sunscreen product; and(d) have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and(e) if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604:2021; and(f) meet the performance requirements for a broad‑spectrum product set out in clause 5.3 and Table 1 in clause 4.2 of AS/NZS 2604:2021	when the product:(a) is not advertised or presented for supply as having a sun protection factor of more than 15; and(b) is not advertised or presented for supply as being water-resistant; and(c) if the product is not stable for at least 36 months—includes an expiry date on its label; and(d) has a pack size not larger than 300 mL or 300 g; and(e) does not have any therapeutic claims made in relation to it (including claims about skin cancer), other than those in relation to premature ageing in connection with sun exposure
11	therapeutic goods for retaining, cushioning or repairing dentures	when advertised or presented for supply to the ultimate consumer

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Name

This instrument is the Therapeutic Goods (Excluded Goods) Determination 2018.

3 Authority

This instrument is made under section 7AA 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:

(a) advertise;
(b) label;
(c) medical device;
(d) medicine;
(e) Register;
(f) supply;
(g) therapeutic use.

In this instrument:

Act means the Therapeutic Goods Act 1989.

haematopoietic progenitor cells has the meaning given by clause 1 of Part 1 of Schedule 9 to the Regulations.

health professional has the same meaning as in the Medical Devices Regulations.

Medical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

Poisons Standard means the legislative instrument made under section 52D of the Act, as in force immediately before the commencement of this instrument.

Regulations means the Therapeutic Goods Regulations 1990.

secondary sunscreen product has the same meaning as in AS/NZS 2604:2021.

serious, for a condition, ailment or defect, has the same meaning as in the Medical Devices Regulations.

serious disease has the same meaning as in the Medical Devices Regulations.

5 Excluded goods

For subsection 7AA(1) of the Act, the goods specified in Schedule 1 are excluded goods for the purposes of the Act.

6 Excluded goods when used, advertised or presented for supply in a particular way

Compliance under this Determination means constructing and documenting a clear, auditable factual record that shows a product meets the specific conditions for exclusion. The following checklist maps concrete steps to the instrument’s text.

Identify the correct Schedule item. Start by matching the product to the precise Schedule 1 or Schedule 2 item that appears to describe it. Read the full wording , many items use narrow language (for example Schedule 1, items 14-15 for sunscreen-containing tinted bases/foundations; Schedule 1 items 14A-14N for software categories; Schedule 2 items 4A-4E for human-derived goods).
Confirm compositional exclusions with the Poisons Standard. Where an item requires that the product “do not contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard” (e.g. Schedule 1, items 14 and 15; Schedule 2, items 5 and 10), verify each ingredient against the current Poisons Standard. Retain batch specifications and ingredient declarations as evidence.
For sunscreens, comply with AS/NZS 2604:2021 requirements and label clauses. If the exclusion depends on ASNZS 2604:2021 clauses (e.g. Schedule 1, items 14 and 15; Schedule 2, items 5 and 10), ensure product testing meets clause 5.3 broad‑spectrum performance requirements and Table 1 in clause 4.2. Ensure labels follow clause 5 and, if a protection factor is stated, the label meets clauses 6.1 and 6.3. Maintain test reports, certified lab records and labelled artwork as documentary proof.
Observe pack-size and water-resistance restrictions. Some Schedule 2 sunscreen exclusions require pack size not larger than 300 mL or 300 g and non-presentation as water-resistant. Ensure packaging SKUs respect those limits and that marketing materials do not claim water resistance where the exclusion forbids it.
Control advertising language strictly. For Schedule 2 items that depend on advertising or presentation (for example, anti-acne/dandruff entries, antibacterial skin care products, oral hygiene products), develop pre-publication compliance checks for all marketing copy, including online descriptions, point-of-sale material, and social media. Avoid claims of diagnosis, treatment, prevention of disease, or claims of activity beyond the permitted functions (e.g. cleansing, moisturising, exfoliating, drying).
Document manufacturer’s intended use for software. For software exclusions under Schedule 1 (items 14A-14N), draft a concise intended-use statement and a product description that aligns with the item’s language (for example, consumer self-management for non‑serious conditions, not for clinical practice or diagnostic decision-making). Align user documentation, marketing and technical specifications to that intended use. Capture internal sign-offs and version-controlled product specifications as proof.
Keep robust records for clinical manufacture of human-derived products. For Schedule 2, item 4A, retain clinical records showing the relevant patient/ practitioner relationship, a registered practitioner’s oversight, hospital manufacture records, and any contracts for outsourced storage or testing. Ensure products are used for the relevant patient only and are not advertised directly to consumers.
Ensure conformity to AS 2896-2011 for piped medical gas systems. For Schedule 2, item 8, document compliance with AS 2896-2011 and retain installation and testing records demonstrating conformity.
For Government-endorsed kits, obtain express authorisation in writing. Schedule 2, item 7’s exclusion requires that the kit be advertised or presented as part of a Government endorsed health promotion program and expressly authorised. Seek written confirmation from the relevant government agency and retain that authorising instrument.
Manage pack composition across SKUs. A change in formulation that introduces a scheduled poison, or a change in label or packing (e.g. a larger size or different marketing claim), can change classification. Treat product variation as a regulatory event requiring re-assessment against the Determination.
Use version control and dated evidence. Because the Determination ties exclusions to particular versions of standards and to pre-amendment conditions for the transitional saving (Part 7), keep dated evidence showing when a specific edition of a standard was used, and whether the goods were excluded on 30 June 2024 where the saving applies. Track the 1 July 2029 deadline for grandfathered goods.
Prepare for audits and regulator queries. Because the Determination hinges on factual matters susceptible to audit (lab reports, manufacturer’s intention statements, advertising copy, clinical manufacturing logs), assemble a compliance pack for each excluded product that includes ingredient declarations, lab test reports, label proofs, marketing approvals, and internal policies showing how the product meets each Schedule condition.
Seek regulatory advice if borderline. If there is uncertainty , for example, whether a software feature could reasonably be construed as “making a recommendation or decision about the treatment of a disease” (Schedule 1 items 14A-14D) or whether marketing crosses advertised purpose limitations , document the uncertainty and seek a regulator view or legal advice. The Determination’s exclusion is factual and contextual; proactive resolution reduces enforcement exposure.
Monitor changes in referenced instruments. Because changes to the Poisons Standard, AS/NZS 2604:2021, AS 2896-2011 or related instruments may affect exclusion status, assign regulatory responsibility to monitor those instruments and trigger product re-assessment when updates occur.

In sum, compliance under this Determination is a process of precise fit: match the product to the exact Schedule language; document proof of conformity to all conjunctive conditions; control advertising and labelling; and retain records enabling a regulator to verify that the product legitimately falls outside the Act’s scope.

Therapeutic Goods (Excluded Goods) Determination 2018

Plain English Summary

Deep Dive

What it does

Current sections

Name

1 Name

Authority

3 Authority

Definitions

4 Definitions

Excluded goods

5 Excluded goods

Excluded goods when used, advertised or presented for supply in a particular way

6 Excluded goods when used, advertised or presented for supply in a particular way

Source text: opening excerpt

1 Name

1 Name

3 Authority

3 Authority

4 Definitions

4 Definitions

5 Excluded goods

5 Excluded goods

6 Excluded goods when used, advertised or presented for supply in a particular way

6 Excluded goods when used, advertised or presented for supply in a particular way

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply