Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

This specification, made under subsection 61(5D) of the Therapeutic Goods Act 1989, prescribes the specific kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act (see s 3 and s 5). The instrument is procedural and declaratory: it does not itself create an approval power; it categorises the information types that may be published in connection with approvals granted under section 19A of the Act. The specification was made 15 December 2017 by a delegate of the Minister for Health, was registered 19 December 2017 and, under s 2, commenced the day after registration.

Mechanically, s 5 of the specification operates by pointing to Schedule 1. Schedule 1 sets out eleven discrete items (items 1 to 11), each a “kind of therapeutic goods information” with a precise description in column 3. The items are tied to two central classes of goods and processes referenced in the Act: registered goods that are “unavailable or in short supply in Australia” and “specified therapeutic goods approved under section 19A of the Act”. Many of the items link the published information to approvals given under section 19A, for example particulars of goods approved under section 19A (item 2), the identity and contact details of the person to whom a section 19A approval is granted (item 4), and the expiry date of such approvals (item 7).

Operationally the specification requires no new database or separate statutory regime; rather it standardises what the Secretary may disclose publicly. Certain items require the Secretary to publish hyperlinks to existing public resources where they exist, for example to the Medicine Shortages Information Initiative database for active-ingredient-related shortage information (item 9) and to the Pharmaceutical Benefits Scheme website for PBS information (item 11), or otherwise to confirm absence of such public information. Other items require publication of particulars, including trade name, active ingredient, strength, dosage form and registration number for unavailable or short-supply registered goods (item 3), or photographic images of packaging as supplied in one or more foreign countries with a detailed list of packaging data (item 5).

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Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health, make this specification under subsection 61(5D) of the Therapeutic Goods Act 1989.

Dated 15 December 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1 Name of specification

This specification is the Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017.

2 Commencement

(1) Each provision of this specification 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.

<table cellspacing="0" cellpadding="0" style="width:93.68%; margin-left:14.2pt; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Commencement information</span></p></td></tr><tr><td style="width:25.54%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 1</span></p></td><td style="width:55.22%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 2</span></p></td><td style="width:19.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 3</span></p></td></tr><tr><td style="width:25.54%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Provisions</span></p></td><td style="width:55.22%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Commencement</span></p></td><td style="width:19.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:25.54%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">1.</span><span style="font-size:10pt"> </span><span style="font-size:10pt">The whole of this </span><span style="font-size:10pt">specification</span></p></td><td style="width:55.22%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">The day after this </span><span style="font-size:10pt">specification</span><span style="font-size:10pt"> </span><span style="font-size:10pt">is registered.</span></p></td><td style="width:19.24%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">19 Dec</span><span style="font-size:10pt">e</span><span style="font-size:10pt">mber</span><span style="font-size:10pt"> 2017</span></p></td></tr></tbody></table>

Note: This table relates only to the provisions of this specification as originally made. It will not be amended to deal with any later amendments of this specification.

(2) Any information in column 3 of the table is not part of this specification. Information may be inserted in this column, or information in it may be edited, in any published version of this specification.

3 Authority

This specification is made under subsection 61(5D) of the Therapeutic Goods Act 1989.

4 Definitions

In this specification:

Act means the Therapeutic Goods Act 1989.

active ingredient has the meaning as in section 2 of the Therapeutic Goods Regulations 1990.

Note A number of expressions used in this specification are defined in the Act, including the following:

Note: (a) included in the Register;

Note: (b) indications;

Note: (c) Register;

Note: (d) registered goods;

Note: (e) registration number;

Note: (f) sponsor;

Note: (g) therapeutic goods;

Note: (h) therapeutic goods information; and

Note: (i) therapeutic use.

5 Therapeutic goods information

The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.

Note Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).

Schedule 1 Specified kinds of therapeutic goods information

(section 5)

For each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.

<table cellspacing="0" cellpadding="0" style="width:425.3pt; margin-right:9pt; margin-left:9pt; border-collapse:collapse; float:left"><thead><tr style="height:16.1pt"><td colspan="5" style="width:414.5pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">K</span><span style="font-size:11pt; font-weight:bold">inds of therapeutic goods information</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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; margin-left:1.7pt; text-indent:-1.7pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 1</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Item</span></p></td><td colspan="2" style="width:123.9pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 2</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">I</span><span style="font-size:11pt; font-weight:bold">nformation</span></p></td><td colspan="2" style="width:216pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 3</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Description</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:53pt; 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; margin-left:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">1</span></p></td><td colspan="2" style="width:123.9pt; 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; margin-left:1.7pt; line-height:12pt"><span style="font-size:11pt">n</span><span style="font-size:11pt">ame of a</span><span style="font-size:11pt">ctive ingredient</span><span style="font-size:11pt"> of registered goods</span></p></td><td colspan="2" style="width:216pt; 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; margin-left:1.7pt; line-height:12pt"><span style="font-size:11pt">the </span><span style="font-size:11pt">name of </span><span style="font-size:11pt">one or more </span><span style="font-size:11pt">active ingredient</span><span style="font-size:11pt">s</span><span style="font-size:11pt"> </span><span style="font-size:11pt">of </span><span style="font-size:11pt">the </span><span style="font-size:11pt">registered </span><span style="font-size:11pt">goods</span><span style="font-size:11pt"> </span><span style="font-size:11pt">described in column 3 of item</span><span style="font-size:11pt"> </span><span style="font-size:11pt">3</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">2</span></p></td><td colspan="2" style="width:123.9pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">p</span><span style="font-size:11pt">articulars </span><span style="font-size:11pt">of s</span><span style="font-size:11pt">pecified therapeutic goods </span><span style="font-size:11pt">approved </span><span style="font-size:11pt">under section 19A</span></p></td><td colspan="2" style="width:216pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he </span><span style="font-size:11pt">name </span><span style="font-size:11pt">of specified therapeutic goods </span><span style="font-size:11pt">approved </span><span style="font-size:11pt">under section 19A of the Act</span><span style="font-size:11pt"> </span><span style="font-size:11pt">for which the registered goods described in column</span><span style="font-size:11pt"> </span><span style="font-size:11pt">3 of item 3 may be substituted, </span><span style="font-size:11pt">comprising the trade </span><span style="font-size:11pt">name, </span><span style="font-size:11pt">active ingredient name, strength and dosage form</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">3</span></p></td><td colspan="2" style="width:123.9pt; 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:12pt"><span style="font-size:11pt">p</span><span style="font-size:11pt">articulars </span><span style="font-size:11pt">of r</span><span style="font-size:11pt">egistered </span><span style="font-size:11pt">goods</span></p></td><td colspan="2" style="width:216pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he n</span><span style="font-size:11pt">ame of </span><span style="font-size:11pt">one or more </span><span style="font-size:11pt">therapeutic goods included in the Register </span><span style="font-size:11pt">that </span><span style="font-size:11pt">are unavailable or in short supply in Australia</span><span style="font-size:11pt"> comprising </span><span style="font-size:11pt">the trade name, active ingredient name, strength</span><span style="font-size:11pt">,</span><span style="font-size:11pt"> dosage form </span><span style="font-size:11pt">and registration number</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">4</span></p></td><td colspan="2" style="width:123.9pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">n</span><span style="font-size:11pt">ame of p</span><span style="font-size:11pt">erson to whom approval </span><span style="font-size:11pt">is granted </span><span style="font-size:11pt">under section 19A</span></p></td><td colspan="2" style="width:216pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he n</span><span style="font-size:11pt">ame</span><span style="font-size:11pt">, contact telephone number and Australian Business Number </span><span style="font-size:11pt">of the person to</span><span style="font-size:11pt"> </span><span style="font-size:11pt">whom </span><span style="font-size:11pt">an </span><span style="font-size:11pt">approval </span><span style="font-size:11pt">for importation </span><span style="font-size:11pt">into</span><span style="font-size:11pt"> Australia</span><span style="font-size:11pt">, or </span><span style="font-size:11pt">the </span><span style="font-size:11pt">supply </span><span style="font-size:11pt">in Australia</span><span style="font-size:11pt">,</span><span style="font-size:11pt"> of specified </span><span style="font-size:11pt">therapeutic goods </span><span style="font-size:11pt">is </span><span style="font-size:11pt">granted under section 19A of the</span><span style="font-size:11pt"> </span><span style="font-size:11pt">Act</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">5</span></p></td><td colspan="2" style="width:123.9pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:1.7pt; line-height:12pt"><span style="font-size:11pt">i</span><span style="font-size:11pt">mage of specified therapeutic goods packaging</span></p></td><td colspan="2" style="width:216pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:1.7pt; line-height:12pt"><span style="font-size:11pt">o</span><span style="font-size:11pt">ne or more </span><span style="font-size:11pt">p</span><span style="font-size:11pt">hotographic or pictorial image</span><span style="font-size:11pt">s</span><span style="font-size:11pt"> of the </span><span style="font-size:11pt">packaging of </span><span style="font-size:11pt">the </span><span style="font-size:11pt">specified therapeutic goods </span><span style="font-size:11pt">approved under section 19A of the Act, </span><span style="font-size:11pt">as supplied in </span><span style="font-size:11pt">one or more </span><span style="font-size:11pt">foreign countr</span><span style="font-size:11pt">ies</span><span style="font-size:11pt">, display</span><span style="font-size:11pt">ing</span><span style="font-size:11pt"> </span><span style="font-size:11pt">in relation to the goods</span><span style="font-size:11pt">:</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.55pt; margin-bottom:3pt; text-indent:-17.85pt; line-height:12pt"><span style="font-size:11pt"><span>(a)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the name and address of the </span><span style="font-size:11pt">person in whose name the goods are registered or approved for general marketing</span><span style="font-size:11pt">;</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.55pt; margin-bottom:3pt; text-indent:-17.85pt; line-height:12pt"><span style="font-size:11pt"><span>(b)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the </span><span style="font-size:11pt">name of </span><span style="font-size:11pt">one or more </span><span style="font-size:11pt">active ingredient</span><span style="font-size:11pt">s</span><span style="font-size:11pt">;</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.55pt; margin-bottom:3pt; text-indent:-17.85pt; line-height:12pt"><span style="font-size:11pt"><span>(c)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the strength, dosage form</span><span style="font-size:11pt"> and</span><span style="font-size:11pt"> pack size</span><span style="font-size:11pt">;</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.55pt; margin-bottom:3pt; text-indent:-17.85pt; line-height:12pt"><span style="font-size:11pt"><span>(d)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the name of the manufacturer</span><span style="font-size:11pt">;</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:11pt"></span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:11pt"></span></p></td></tr><tr style="height:0pt"><td style="width:63.8pt"></td><td style="width:127.6pt"></td><td style="width:7.1pt"></td><td style="width:219.7pt"></td><td style="width:7.1pt"></td></tr></tbody></table>

<table cellspacing="0" cellpadding="0" style="width:425.3pt; margin-right:9pt; margin-left:9pt; border-collapse:collapse; float:left"><thead><tr style="height:16.1pt"><td colspan="5" style="width:414.5pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">K</span><span style="font-size:11pt; font-weight:bold">inds of therapeutic goods information</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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; margin-left:1.7pt; text-indent:-1.7pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 1</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Item</span></p></td><td colspan="2" style="width:123.9pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 2</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">I</span><span style="font-size:11pt; font-weight:bold">nformation</span></p></td><td colspan="2" style="width:216pt; 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; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Column 3</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-size:11pt; font-weight:bold">Description</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt"></span></p></td><td colspan="2" style="width:123.9pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt"></span></p></td><td colspan="2" style="width:216pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:19.7pt; text-indent:-18pt; line-height:12pt"><span style="font-size:11pt"><span>(e)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the name of the distributor, if different from the person in whose name the goods are registered or approved for general marketing;</span></p><p class="ListParagraph" style="margin-left:19.7pt; text-indent:-18pt; line-height:12pt"><span style="font-size:11pt"><span>(f)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the </span><span style="font-size:11pt">reference number of the goods registered or approved for general marketing in one or more foreign countries;</span></p><p class="ListParagraph" style="margin-left:19.7pt; text-indent:-18pt; line-height:12pt"><span style="font-size:11pt"><span>(g)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the storage conditions</span><span style="font-size:11pt">;</span></p><p class="ListParagraph" style="margin-left:19.7pt; text-indent:-18pt; line-height:12pt"><span style="font-size:11pt"><span>(h)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">the batch number and expiry date</span><span style="font-size:11pt">; and</span></p><p class="ListParagraph" style="margin-left:19.7pt; text-indent:-18pt; line-height:12pt"><span style="font-size:11pt"><span>(i)</span></span><span style="font:7pt 'Times New Roman'"> </span><span style="font-size:11pt">any other packaging information including additional administration instructions</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">6</span></p></td><td colspan="2" style="width:123.9pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">i</span><span style="font-size:11pt">ndications</span><span style="font-size:11pt"> </span><span style="font-size:11pt">of </span><span style="font-size:11pt">specified therapeutic goods</span></p></td><td colspan="2" style="width:216pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he therapeutic uses of </span><span style="font-size:11pt">the </span><span style="font-size:11pt">specified therapeutic goods </span><span style="font-size:11pt">specified in the </span><span style="font-size:11pt">relevant </span><span style="font-size:11pt">notice of approval as a condition of that approval </span><span style="font-size:11pt">under section 19A of the Act</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">7</span></p></td><td style="width:116.8pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">e</span><span style="font-size:11pt">xpiry date</span><span style="font-size:11pt"> of approval</span></p></td><td colspan="2" style="width:216pt; 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:8.75pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he d</span><span style="font-size:11pt">ate </span><span style="font-size:11pt">on which </span><span style="font-size:11pt">the</span><span style="font-size:11pt"> </span><span style="font-size:11pt">approval under </span><span style="font-size:11pt">paragraph </span><span style="font-size:11pt">19A</span><span style="font-size:11pt">(8)(a)</span><span style="font-size:11pt"> of the </span><span style="font-size:11pt">Act expire</span><span style="font-size:11pt">s</span><span style="font-size:11pt">, as specified in the </span><span style="font-size:11pt">relevant </span><span style="font-size:11pt">notice </span><span style="font-size:11pt">of approval</span></p></td><td style="border-top:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">8</span></p></td><td style="width:116.8pt; 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:1.7pt; line-height:12pt"><span style="font-size:11pt">i</span><span style="font-size:11pt">nformation </span><span style="font-size:11pt">relating to </span><span style="font-size:11pt">the </span><span style="font-size:11pt">lapsing of </span><span style="font-size:11pt">any approval </span><span style="font-size:11pt">under section 19A </span><span style="font-size:11pt">for </span><span style="font-size:11pt">the </span><span style="font-size:11pt">specified therapeutic goods</span></p></td><td colspan="2" style="width:216pt; 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:8.75pt; line-height:12pt"><span style="font-size:11pt">t</span><span style="font-size:11pt">he date </span><span style="font-size:11pt">on which </span><span style="font-size:11pt">any previous approval </span><span style="font-size:11pt">under section 19A </span><span style="font-size:11pt">was</span><span style="font-size:11pt"> granted</span><span style="font-size:11pt"> in relation to </span><span style="font-size:11pt">the </span><span style="font-size:11pt">specified therapeutic goods</span><span style="font-size:11pt">, the period for which it was granted as specified in the </span><span style="font-size:11pt">relevant </span><span style="font-size:11pt">notice of approval, the </span><span style="font-size:11pt">date </span><span style="font-size:11pt">on which the approval lapsed, and the </span><span style="font-size:11pt">reason for </span><span style="font-size:11pt">such lapsing in accordance with </span><span style="font-size:11pt">paragraph </span><span style="font-size:11pt">19A(8)</span><span style="font-size:11pt">(b)</span><span style="font-size:11pt"> and </span><span style="font-size:11pt">subsection </span><span style="font-size:11pt">19A(9) of the Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">9</span></p></td><td style="width:116.8pt; 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:1.65pt; line-height:12pt"><span style="font-size:11pt">m</span><span style="font-size:11pt">edicine shortage</span><span style="font-size:11pt">s information</span></p></td><td colspan="2" style="width:216pt; 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:8.75pt; line-height:12pt"><span style="font-size:11pt">a hyperlink to </span><span style="font-size:11pt">i</span><span style="font-size:11pt">nformation </span><span style="font-size:11pt">relating to the active ingredient </span><span style="font-size:11pt">described in column 3 of item 1 </span><span style="font-size:11pt">that is </span><span style="font-size:11pt">publicly </span><span style="font-size:11pt">available</span><span style="font-size:11pt">, by reason other than this s</span><span style="font-size:11pt">pecification,</span><span style="font-size:11pt"> </span><span style="font-size:11pt">on the </span><span style="font-size:11pt">Medicine Shortages Information Initiative database </span><span style="font-size:11pt">on the Therapeutic Goods Administration website</span><span style="font-size:11pt">; or, in the event that there is no such in</span><span style="font-size:11pt">formation, confirmation that no</span><span style="font-size:11pt"> information is publicly available on the Medicines Shortages Information Initiative database in relation to that ingredient</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:16.1pt"><td style="width:53pt; 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:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">10</span></p></td><td style="width:116.8pt; 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:1.65pt; line-height:12pt"><span style="font-size:11pt">supply information</span></p></td><td colspan="2" style="width:216pt; 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:8.75pt; line-height:12pt"><span style="font-size:11pt">information relating to </span><span style="font-size:11pt">the availability </span><span style="font-size:11pt">of the specified therapeutic goods</span><span style="font-size:11pt"> during the period of approval</span><span style="font-size:11pt"> under section 19A of the Act</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:12pt"><span style="font-size:11pt">11</span></p></td><td style="width:116.8pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:1.65pt; line-height:12pt"><span style="font-size:11pt">pharmaceutical benefits scheme information</span></p></td><td colspan="2" style="width:216pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:8.75pt; line-height:12pt"><span style="font-size:11pt">a hyperlink to </span><span style="font-size:11pt">information relating to the specified </span><span style="font-size:11pt">therapeutic </span><span style="font-size:11pt">goods, that is </span><span style="font-size:11pt">publicly available, </span><span style="font-size:11pt">by reason other than this specification</span><span style="font-size:11pt">,</span><span style="font-size:11pt"> </span><span style="font-size:11pt">on the Pharmaceutical Benefits Scheme </span><span style="font-size:11pt">website</span><span style="font-size:11pt">; or</span><span style="font-size:11pt">,</span><span style="font-size:11pt"> in the event that there is no such information</span><span style="font-size:11pt">, confirmation that no</span><span style="font-size:11pt"> information is publicly available on the Pharmaceutical Benefits Scheme website in relation to th</span><span style="font-size:11pt">ose</span><span style="font-size:11pt"> goods</span></p></td><td style="vertical-align:top"></td></tr></tbody><tbody><tr style="height:0pt"><td style="width:63.8pt"></td><td style="width:127.6pt"></td><td style="width:7.1pt"></td><td style="width:219.7pt"></td><td style="width:7.1pt"></td></tr></tbody></table>

Note

Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See http://www.legislation.gov.au.

1 Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health, make this specification under subsection 61(5D) of the Therapeutic Goods Act 1989.

Dated 15 December 2017

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1 Name of specification

This specification is the Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017.

2 Commencement

<table cellspacing="0" cellpadding="0" style="width:93.68%; margin-left:14.2pt; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Commencement information</span></p></td></tr><tr><td style="width:25.54%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 1</span></p></td><td style="width:55.22%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 2</span></p></td><td style="width:19.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Column 3</span></p></td></tr><tr><td style="width:25.54%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Provisions</span></p></td><td style="width:55.22%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Commencement</span></p></td><td style="width:19.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:25.54%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">1.</span><span style="font-size:10pt"> </span><span style="font-size:10pt">The whole of this </span><span style="font-size:10pt">specification</span></p></td><td style="width:55.22%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">The day after this </span><span style="font-size:10pt">specification</span><span style="font-size:10pt"> </span><span style="font-size:10pt">is registered.</span></p></td><td style="width:19.24%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">19 Dec</span><span style="font-size:10pt">e</span><span style="font-size:10pt">mber</span><span style="font-size:10pt"> 2017</span></p></td></tr></tbody></table>

The specification is narrow in ambition: it specifies kinds of “therapeutic goods information” for release under s 61(5C) of the Act. That phrase is one of those identified as defined in the Act (see s 4, notes). The specification itself defines only a small number of terms directly. It imports other terms from the Act and Regulations. Notably, “active ingredient” is defined by reference to section 2 of the Therapeutic Goods Regulations 1990 (s 4).

Two statutory constructs are central to the schedule. First, “registered goods” included in the Register that are “unavailable or in short supply in Australia” are the subject of item 3 (names and particulars). Second, “specified therapeutic goods approved under section 19A” appear across items 2, 4-8, 10 and 11. Section 19A (not reproduced in the specification) is the Act provision that authorises approval for importation or supply of specified therapeutic goods, typically in response to shortages; the specification repeatedly cross-references paragraph 19A(8)(a), paragraph 19A(8)(b) and subsection 19A(9) when defining expiry and lapsing information (items 7 and 8).

Schedule 1 is structured as a table of items. Each item is a distinct kind of information, for example:

Item 1: name of active ingredient(s) of the registered goods described in item 3. The description links the active ingredient entry to item 3’s registered goods.
Item 2: particulars of specified therapeutic goods approved under s 19A, comprising trade name, active ingredient, strength and dosage form.
Item 3: particulars of registered goods that are unavailable or in short supply, to include trade name, active ingredient, strength, dosage form and registration number.
Item 4: name, contact telephone number and Australian Business Number of the person to whom an approval under s 19A is granted.
Item 5: one or more photographic or pictorial images of packaging of the specified therapeutic goods as supplied in one or more foreign countries, together with a detailed list of packaging data (a)-(i), including registered owner, manufacturer, distributor, pack size, storage conditions, batch number and expiry date, and any additional administration instructions.
Item 6: indications, that is the therapeutic uses of the specified therapeutic goods as specified in the relevant notice of approval as a condition of approval under s 19A.
Item 7: expiry date of approval as specified in the relevant notice of approval under paragraph 19A(8)(a).
Item 8: information relating to the lapsing of any approval under s 19A, including the date of grant, the original period for the approval, date the approval lapsed and the reason for lapsing in accordance with paragraph 19A(8)(b) and subsection 19A(9).
Item 9: medicine shortages information, implemented as a hyperlink to the Medicine Shortages Information Initiative database on the TGA website that is publicly available by reason other than this specification, or confirmation that no such information is publicly available on that database.
Item 10: supply information, that is information relating to the availability of the specified therapeutic goods during the period of approval under s 19A.
Item 11: Pharmaceutical Benefits Scheme information, implemented as a hyperlink to PBS website information publicly available independently of this specification, or confirmation that no such PBS information is publicly available.

The specification is an instrument under the Act that operationalises transparency around shortage-related authorisations. It is not a standalone regulatory regime. It connects the Secretary’s discretion under s 61(5C) to a fixed catalogue of fields for public release in shortage and replacement-supply contexts, and it explicitly relies on external public resources (Medicine Shortages Initiative and PBS) where available.

The specification names neither prohibited nor mandatory actors, but its practical effect touches several identifiable groups because of the categories of information it describes.

The Secretary of the Department of Health is the decision-maker who may release the specified information under subsection 61(5C) of the Act. The specification explicitly contemplates public release by the Secretary (s 5 and the Note to s 5).
Persons to whom approvals under section 19A are granted will be affected directly because item 4 requires publication of the name, contact telephone number and Australian Business Number of that person. Those persons commonly include importers, sponsors or suppliers authorised to import or supply a non-registered or overseas product for use in Australia during a shortage.
Sponsors and holders of registrations for goods listed in the Register are affected. Item 3 requires publication of particulars of registered goods that are unavailable or in short supply, including trade name, active ingredient, strength, dosage form and registration number. Sponsors of registered goods therefore have their registered product identifiers exposed in any public notice linked to a s 19A approval.
Manufacturers, distributors and foreign marketing authorisation holders are implicated by item 5, which contemplates publication of images of foreign packaging together with detailed packaging data (manufacturer name, distributor name, reference numbers in foreign jurisdictions, storage conditions, batch number, expiry date, pack size, and any other packaging information).
Healthcare providers, pharmacists and procurement officers are secondary affected parties because the published information is designed to inform substitution and supply decisions. Item 2 and item 6 link specified therapeutic goods approved under s 19A to the trade name, active ingredient, strength, dosage form and therapeutic uses in the approval notice.
Patients and consumer groups are affected as recipients of the public information that explains which products are being imported or supplied as substitutes, which registered goods are in short supply and where to find shortage-related information via the Medicine Shortages Information Initiative or PBS hyperlinks (items 9 and 11).
Journalists, compliance officers and researchers will be able to access a standardised set of fields about approvals and substitute products, including packaging imagery and supply availability statements (items 5 and 10).

Who pays: the specification itself does not create fees or direct monetary obligations. However, the practical costs fall on affected commercial parties in two ways. First, reputational and commercial exposure arises because trade names, registration numbers, ABNs and contact numbers may be published. Second, affected parties may incur administrative costs to ensure that the Register entries, foreign packaging images and related records are accurate and aligned with any information the Secretary publishes.

Who decides: the Secretary (and delegates) decide whether to release information under s 61(5C). The specification defines what may be released, not what must be released; the Act’s discretion remains central. The specification does not itself create appeal processes, nor does it prescribe a schedule for release. It anchors the Secretary’s disclosure power to a set of fields that must be understood and managed by sponsors, importers and manufacturers if they are to anticipate public exposure during a shortage-related approval.

The specification principally defines kinds of information; it is not drafted as an instrument that imposes new statutory duties on private parties. Nevertheless, it creates expectations and triggers rights under the Act in respect of public release.

Duties and administrative roles

The Secretary has the administrative authority to release the specified kinds of therapeutic goods information under subsection 61(5C), and the specification identifies those kinds under subsection 61(5D) (s 3 and s 5). The Schedule operationalises that authority by defining what the Secretary may publish in respect of section 19A approvals and related registered goods.
The specification does not itself impose new data-provision duties on sponsors or applicants, nor does it specify the mechanism by which information will be collected for publication. The Schedule prescribes the content of the public disclosures, but the Act’s administrative framework and the terms of any s 19A approval or notice of approval will determine the procedural obligations (s 5 and Schedule 1 items 2, 4, 6, 7, 8, 10).

Rights of the public

Members of the public gain potential access to a standard suite of information about shortage-related approvals and substitute products: active ingredient, trade names, registration numbers, identity and contact details of the person granted approval, packaging images with detailed particulars and hyperlinks to existing public resources such as the Medicine Shortages Information Initiative and the PBS (Schedule 1 items 1-11).
Items 9 and 11 build explicit public rights of access to existing public information by requiring the Secretary to link to external public pages where such information exists, or to confirm that no such public information exists.

Information content rights and limits

The specification mandates publication of tangible identifiers (trade name, registration number) and contact data (telephone number, ABN) for the person to whom a s 19A approval is granted (item 4). This effectively converts administrative approval events into publicised, searchable records containing corporate identifiers.
Packaging images and their associated particulars (item 5) include batch number and expiry date. Publication of batch and expiry particulars is unusual for a specification of this type and could have implications for traceability and pharmacovigilance.

What is not present

The instrument does not set out rights to correct or appeal the content of the published material, nor does it prescribe confidentiality exceptions or explicit limits on the Secretary’s discretion beyond cross-references to section 19A of the Act. It does not provide penalties for failure to provide information nor does it create an express private right of action.

In short, the specification gives the Secretary a menu of fields to disclose and the public a right to be given those fields when the Secretary exercises discretion under s 61(5C). Private parties should treat the schedule as the authoritative list of what may become public in relation to s 19A approvals, and manage their records and public-facing identifiers accordingly.

The specification itself contains no penalty provisions. It is a disclosure specification rather than an enforcement instrument. The text does not create offences, civil penalties or administrative sanctions, nor does it prescribe enforcement mechanisms or compliance penalties. The instrument’s mechanics are confined to naming kinds of therapeutic goods information that may be released under subsection 61(5C) of the Act (s 5 and Schedule 1).

Consequences of publication

The principal “enforcement” effect is reputational and practical: publication of product particulars, packaging images, ABNs, contact details and batch/expiry data can affect commercial behaviour and market responses. Those are indirect consequences rather than penalties imposed by the specification.
Where the underlying Act or its regulations contain offences or other enforcement mechanisms (for example, in relation to false or misleading information, counterfeit goods, sponsor obligations or mislabelling), the Secretary’s public disclosures could trigger enforcement action under those provisions. The specification does not, however, itself create such triggers; it merely defines information types that can be published.

Administrative review

The specification is silent on administrative review or internal appeal rights in relation to publication decisions taken by the Secretary under s 61(5C). It does not provide a statutory right to prevent or delay publication, to require a particular form of publication, or to adjudicate disputes over the content to be released. Any remedies or reviews would need to be sought under the Act’s broader administrative law framework or under general administrative law avenues, not under the specification itself.

Compliance monitoring and accuracy

The specification does not prescribe verification or record-keeping processes for ensuring the accuracy of the published material. Nor does it set timeframes for updating information such as supply availability during the approval period (item 10) or the expiry date of an approval (item 7).

Practical enforcement risk

The absence of penalties in the specification shifts attention to other legislative and administrative instruments for enforcement. Parties concerned about publication of particular fields must therefore look to the underlying Act, to any conditions attached to s 19A approvals, or to non-statutory pathways (for example, negotiations with the Department) if they wish to influence what is published. The specification itself is not an enforcement tool beyond prescribing disclosure categories.

The specification is an instrument under the Therapeutic Goods Act 1989. Its legal operation is expressly tethered to the Act: it is made under subsection 61(5D) and specifies kinds of therapeutic goods information for the purposes of subsection 61(5C) (s 3 and s 5). It therefore interacts with the Act’s disclosure power and with section 19A, which authorises approvals for importation or supply of specified therapeutic goods, a recurring reference point in the Schedule.

Interaction with the Act

The specification does not alter the substantive conditions or criteria of section 19A approvals; it only defines what the Secretary may release publicly in association with those approvals (Schedule 1 repeatedly references “specified therapeutic goods approved under section 19A”).
Items 7 and 8 are specifically linked to paragraph 19A(8)(a), paragraph 19A(8)(b) and subsection 19A(9), meaning the content of any notice of approval under s 19A (for example the expiry date and the reason for lapsing) will be used as the source for published information. The specification therefore relies on the Act’s notice-of-approval mechanics.

Interaction with Regulations and other statutory definitions

The specification imports the definition of “active ingredient” from the Therapeutic Goods Regulations 1990 (see s 4). Other terms such as “Register”, “registration number”, “sponsor” and “therapeutic goods information” are noted as defined in the Act in the explanatory note to s 4. Any legal effect or meaning therefore depends on the Act and Regulations for precise content.

Interaction with external public information repositories

Items 9 and 11 explicitly direct the Secretary to link to other public resources where information already exists independently of this specification: the Medicine Shortages Information Initiative database on the Therapeutic Goods Administration website (item 9) and the Pharmaceutical Benefits Scheme website (item 11). The specification therefore bridges the Act’s disclosure power with existing public data sources rather than requiring duplication of those datasets.
The specification requires that where such information is not otherwise publicly available on those respective databases, the Secretary should publish a confirmation that no such information is publicly available. That design integrates the Secretary’s disclosures with the status of information on related public platforms.

Privacy, confidentiality and commercial information regimes

The specification is silent on protections for commercially sensitive information and for personal or business privacy. It expressly requires publication of corporate identifiers (ABN, telephone number) and potentially commercial details such as foreign registration reference numbers and distributor names (item 5 and item 4). If the Act elsewhere contains confidentiality protections or processes for dealing with commercially sensitive information, those provisions will determine whether particular items can be withheld; the specification itself does not create exemptions or carve-outs.

Legislation Act 2003 and legislative instrument context

The specification is a legislative instrument that will be registered on the Federal Register of Legislation under the Legislation Act 2003, as noted in the instrument’s Note. That placement affects how the instrument is accessed and how it is amended in future.

In summary, the specification is a clarifying, content-prescribing instrument that depends for legal force and limits on the Act, the Regulations and any other statutory confidentiality or appeal mechanisms. It integrates the Secretary’s disclosure role under the Act with pre-existing public information systems such as the Medicine Shortages database and the PBS.

The instrument contains a commencement table (s 2) and a note that the table relates only to the specification as originally made and will not be amended to account for later amendments of the specification. The specification was made 15 December 2017, was registered on 19 December 2017 and, per s 2(1), commenced the day after registration. The instrument includes a formal signing: LARRY KELLY, Delegate of the Minister for Health.

The specification does not include any recorded amendments within the instrument text provided. The Note at the end points users to the Federal Register of Legislation kept under the Legislation Act 2003 for the registered instrument and compilations, but the body of the instrument contains no amendment entries or amending schedules. The instrument explicitly warns that the commencement table relates only to the original making of the specification and will not be amended in the instrument to reflect later amendments. That means users seeking an amendment history should consult the public Federal Register of Legislation to view any historical versions, amendments, or replacement instruments.

Practical implications of the amendment design

Because the specification uses an explicit commencement table for the original instrument and states that it will not be amended to reflect later changes, legal practitioners and affected parties should rely on the Federal Register of Legislation or the consolidated legislative database to track amendments. The instrument itself is static in the sense that it documents only the original making.
Any substantive changes to the kinds of information specified would require a later legislative instrument made under subsection 61(5D) and registered in accordance with applicable requirements. Absent an entry in the Schedule or a subsequent instrument, the fields in Schedule 1 as provided remain the operative catalogue.

No retroactive amendments or transitional provisions are set out in the specification. The instrument’s narrow scope and declaratory function limit the need for complex transitional arrangements, but future amendments could matter to sponsors and to persons granted s 19A approvals if the list of publishable fields were broadened or narrowed.

The instrument itself records no litigation, judicial interpretations, or case law. There are no references to court proceedings, tribunal decisions or contested administrative actions in the text provided. The specification functions as a descriptive disclosure schedule and does not include dispute-resolution mechanisms or an internal appeal framework for publication decisions.

What this absence means legally

The lack of litigation history in the instrument is unsurprising given its declaratory and procedural nature. It does not create offences, rights of private action or detailed procedural rights that typically generate litigation. Instead, it standardises data fields for public disclosure associated with s 19A approvals.
That said, publication decisions made under the Act and informed by this specification could in practice give rise to administrative law challenges in the future, for example if a party sought to prevent publication of an ABN, contact number, or packaging image on grounds of confidentiality, commercial harm or privacy. Those possibilities are outside the document’s text and not recorded in the instrument.

Practical research routes

To identify any case law that has engaged with the operation of this specification in the years since it came into force, search administrative law decisions, Federal Court and Federal Circuit Court decisions, and tribunal records for challenges to TGA disclosure decisions under section 61(5C) or for disputes concerning section 19A approvals. The specification itself does not provide citations or examples.
Users should also review the Federal Register of Legislation and the Department of Health/TGA publications to find administrative practice notes, guidance or policy documents that explain how the Secretary exercises disclosure discretion in practice. Those sources may be relevant if an actual administrative decision taken under s 61(5C) has been challenged.

In sum, the instrument contains no litigation history; any future or past litigation relating to its operation must be identified by separate legal research beyond the text of this specification.

Several practical points follow from the specification’s structure and content that are easily overlooked.

Precision of fields, not process

The specification defines the content of public disclosure in granular terms, for example photographic images of foreign packaging plus a list of packaging particulars including batch number, expiry date and storage conditions (item 5). It does not, however, define the timing, frequency, or format of disclosure. Parties should not assume a fixed publication timetable or a particular file format or database schema for the images and particulars.

Linkage across items

Some items refer to others. Item 1 provides for the “name of active ingredient(s) of the registered goods described in column 3 of item 3”. The specification therefore prescribes linked entries rather than independent fields. Practically, that link means that active ingredient entries published under item 1 will correspond to particular registered goods listed under item 3.

Use of external public sources

Items 9 and 11 require publication as a hyperlink to other public databases where information exists independently of this specification, or a confirmation that no such information is publicly available. This design means that the Secretary will not re-write or duplicate the Medicine Shortages Initiative or PBS content in full; instead the Secretary either points to existing pages or states that none are available. Dependence on third-party or pre-existing public resources creates a risk that the hyperlinks could point to outdated content or that the external data will differ in structure or terminology from the Secretary’s published fields.

Commercial sensitivity and privacy exposure

The specification contemplates publication of an Australian Business Number and telephone number for the approved person (item 4) and detailed packaging information including foreign registration reference numbers, manufacturer and distributor names, batch number and expiry date (item 5). These are potentially commercially sensitive identifiers. The instrument does not provide express confidentiality protections for those fields. The practical consequence is that private parties should treat these disclosures as likely to become publicly accessible if a section 19A approval is granted.

Batch/expiry publication and brand implications

Publication of batch number and expiry date in relation to foreign-supplied packaging (item 5(h)) could create traceability benefits for clinicians and regulators, but it also risks disclosure of supply chain details and batch-specific commercial data. That is unusual for a disclosure schedule and poses possible commercial and operational consequences for manufacturers and distributors.

Lack of procedural safeguards in the specification

The specification does not provide a process for contesting publication, for seeking redaction, or for requesting a delay. It does not describe thresholds for withholding information as confidential or commercially sensitive. Parties seeking to limit publication must therefore rely on any confidentiality provisions in the Act, on conditions attached to the s 19A approval, or on negotiation with the Department.

Scope confined to s 19A-related circumstances

The kinds of information are anchored to approvals and to registered goods in short supply. The specification does not apply to unrelated disclosure contexts. That focus is a constraint but also a potential blind spot: parties may assume that similar disclosures will not occur outside s 19A contexts, which is correct only insofar as other parts of the Act do not provide similar disclosure powers.

No penalties or enforcement mechanisms in the instrument

Because the specification does not create offences or sanctions, parties looking to influence publication through threat of penalty will not find that leverage in this instrument.

In sum, the “gotchas” arise from the specification’s detailed content list, its linkages to external public datasets, its lack of procedural protections for affected private parties, and its potential to reveal commercial identifiers and batch-level data. Those features create operational and reputational risks that sponsors and prospective approval-holders should anticipate.

The specification does not impose explicit procedural duties on private parties, but affected entities should take practical steps to manage the disclosure risk and to facilitate regulatory accuracy. Below are concrete measures aligned to the information fields in Schedule 1.

Audit Register entries and product particulars

Ensure that entries in the Australian Register of Therapeutic Goods accurately record trade names, active ingredient names, strengths, dosage forms and registration numbers. Item 3 contemplates publication of precisely these fields when registered goods are unavailable or in short supply.

Prepare packaging imagery and metadata

For products that may be the subject of s 19A approvals, collate high-resolution photographs of packaging as supplied in foreign countries and maintain an internal index of the metadata itemised in item 5: name/address of the foreign registration holder, active ingredient(s), strength, dosage form, pack size, manufacturer, distributor, foreign reference numbers, storage conditions, batch numbers, expiry dates and any administration instructions. Having those materials ready will speed regulatory interactions and reduce the risk of discrepancies in public notices.

Maintain accurate corporate identifiers

If a person or entity is likely to apply for or accept a s 19A approval, ensure that corporate identifiers such as the Australian Business Number and contact telephone numbers are current, and nominate authorised contacts who can respond to media or clinical enquiries. Item 4 requires publication of the name, contact telephone number and ABN of the person granted approval.

Track and update supply availability information

Item 10 contemplates publication of “supply information” relating to availability during the period of approval. Prepare internal stock, supply chain and distribution status reports that can be shared with the Department or the Secretary on request, and ensure version control so the data published reflect current availability.

Integrate with external public resources

Items 9 and 11 expect that the Secretary will link to the Medicine Shortages Information Initiative database and to PBS pages where those external resources hold relevant information. Sponsors and approval-holders should confirm that their products are recorded correctly on those external platforms, so the hyperlinks the Secretary publishes lead to coherent and accurate material.

Anticipate pharmacovigilance and traceability consequences

Because the specification contemplates publication of batch number and expiry date for foreign-supplied packaging (item 5(h)), approval-holders should ensure robust traceability, recall capacity and pharmacovigilance data collection. Publication of batch-related data may accelerate identification of product-specific safety signals.

Consider confidentiality and administrative options early

The specification does not provide explicit confidentiality mechanisms, so applicants should, before seeking or accepting a s 19A approval, discuss with the Department any concerns about the public release of commercially sensitive details. If confidentiality protections exist under other parts of the Act or in approval conditions, seek those protections as part of the approval process rather than after publication.

Coordinate communications and stakeholder engagement

Because publication is public-facing and can affect clinicians, pharmacists and patients, plan communications strategies to explain substitution products, therapeutic indications (item 6), and any differences from the registered product. Provide clinicians with clinical equivalence information and clear administration instructions where packaging differs from Australian-labelled products.

Document provenance of information

Keep records showing the source of any published data, especially when the Secretary’s publication will link to external databases. Record where packaging images came from, their date, and whether they reflect current labelling in the foreign jurisdiction to reduce dispute risk over accuracy.

Monitor the TGA and Federal Register

The specification itself does not establish a publication schedule. Parties should monitor the TGA website and the Federal Register of Legislation for actual notices, release formats and any subsequent changes to the specification or the Department’s disclosure practice.

In short, compliance is proactive record-keeping, accuracy in public-facing identifiers, preparedness to provide packaging imagery, and early engagement with the Department about confidentiality concerns. Because the specification provides the Secretary with a defined list of publishable fields, the sensible compliance strategy is to assume these fields will be disclosed upon a s 19A approval and to prepare records and communication strategies accordingly.

Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

Plain English Summary

Deep Dive

What it does

Current sections

Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

Source text: opening excerpt

1 Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017

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