{"id":"F2017L01637","name":"Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017","slug":"therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":144416,"registerId":"commonwealth-F2017L01637-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017","content":"![](image.001.png)\n\nTherapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017\n\nTherapeutic Goods Act 1989\n\nI, LARRY KELLY, a delegate of the Minister for Health, make this specification under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\nDated 15 December 2017\n\n(Signed by)\n\nLARRY KELLY\n\nDelegate of the Minister for Health\n\n \n\n1 Name of specification\n\nThis specification is the Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017.\n\n2 Commencement\n\n(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.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this specification

The day after this specification is registered.

19 December 2017

\n```\n\nNote: This table relates only to the provisions of this specification as originally made.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.\n\n(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.\n\n3 Authority\n\nThis specification is made under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\n4 Definitions\n\nIn this specification:\n\nAct means the Therapeutic Goods Act 1989.\n\nactive ingredient has the meaning as in section 2 of the Therapeutic Goods Regulations 1990.\n\n> Note A number of expressions used in this specification are defined in the Act, including the following:\n\n> Note: (a) included in the Register;\n\n> Note: (b) indications;\n\n> Note: (c) Register;\n\n> Note: (d) registered goods;\n\n> Note: (e) registration number;\n\n> Note: (f) sponsor;\n\n> Note: (g) therapeutic goods;\n\n> Note: (h) therapeutic goods information; and\n\n> Note: (i) therapeutic use.\n\n5 Therapeutic goods information\n\nThe 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.\n\n> 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).\n\nSchedule 1 Specified kinds of therapeutic goods information\n\n(section 5)\n\nFor 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.\n\n```html\n

Kinds of therapeutic goods information

Column 1

Item

Column 2

Information

Column 3

Description

1

name of active ingredient of registered goods

the name of one or more active ingredients of the registered goods described in column 3 of item 3

2

particulars of specified therapeutic goods approved under section 19A

the name of specified therapeutic goods approved under section 19A of the Act for which the registered goods described in column 3 of item 3 may be substituted, comprising the trade name, active ingredient name, strength and dosage form

3

particulars of registered goods

the name of one or more therapeutic goods included in the Register that are unavailable or in short supply in Australia comprising the trade name, active ingredient name, strength, dosage form and registration number

4

name of person to whom approval is granted under section 19A

the name, contact telephone number and Australian Business Number of the person to whom an approval for importation into Australia, or the supply in Australia, of specified therapeutic goods is granted under section 19A of the Act

5

image of specified therapeutic goods packaging

one or more photographic or pictorial images of the packaging of the specified therapeutic goods approved under section 19A of the Act, as supplied in one or more foreign countries, displaying in relation to the goods:

(a) the name and address of the person in whose name the goods are registered or approved for general marketing;

(b) the name of one or more active ingredients;

(c) the strength, dosage form and pack size;

(d) the name of the manufacturer;

\n```\n\n```html\n

Kinds of therapeutic goods information

Column 1

Item

Column 2

Information

Column 3

Description

(e) the name of the distributor, if different from the person in whose name the goods are registered or approved for general marketing;

(f) the reference number of the goods registered or approved for general marketing in one or more foreign countries;

(g) the storage conditions;

(h) the batch number and expiry date; and

(i) any other packaging information including additional administration instructions

6

indications of specified therapeutic goods

the therapeutic uses of the specified therapeutic goods specified in the relevant notice of approval as a condition of that approval under section 19A of the Act

7

expiry date of approval

the date on which the approval under paragraph 19A(8)(a) of the Act expires, as specified in the relevant notice of approval

8

information relating to the lapsing of any approval under section 19A for the specified therapeutic goods

the date on which any previous approval under section 19A was granted in relation to the specified therapeutic goods, the period for which it was granted as specified in the relevant notice of approval, the date on which the approval lapsed, and the reason for such lapsing in accordance with paragraph 19A(8)(b) and subsection 19A(9) of the Act

9

medicine shortages information

a hyperlink to information relating to the active ingredient described in column 3 of item 1 that is publicly available, by reason other than this specification, on the Medicine Shortages Information Initiative database on the Therapeutic Goods Administration website; or, in the event that there is no such information, confirmation that no information is publicly available on the Medicines Shortages Information Initiative database in relation to that ingredient

10

supply information

information relating to the availability of the specified therapeutic goods during the period of approval under section 19A of the Act

11

pharmaceutical benefits scheme information

a hyperlink to information relating to the specified therapeutic goods, that is publicly available, by reason other than this specification, on the Pharmaceutical Benefits Scheme website; or, in the event that there is no such information, confirmation that no information is publicly available on the Pharmaceutical Benefits Scheme website in relation to those goods

\n```\n\nNote\n\n> 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.","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The specification remains tightly focused on its original purpose: authorising publication of information about section 19A approvals granted due to medicine shortages. It has not expanded beyond this specific transparency function."},"complexity_factors":["Short, single-purpose instrument (5 operative sections plus Schedule)","Only 2 defined terms in section 4, with remaining definitions incorporated by reference to parent Act and Regulations","Simple tabular structure in Schedule 1 listing 11 discrete information categories","No nested exceptions or conditional logic — each information type is independently specified","Straightforward cross-referencing to section 19A of the parent Act and Medicine Shortages Information Initiative database","Minimal administrative machinery (commencement table, authority citation, notes)"],"plain_english_summary":"This specification lets the TGA publish specified details about emergency approvals that allow imported substitute medicines when an Australian medicine is scarce or unavailable. It makes information about what’s been approved, who can supply it, and where to find it accessible to patients, clinicians, pharmacists and importers. The aim is to improve transparency and access to safe temporary alternatives while limiting unnecessary disclosure of commercial secrets."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This specification does not expand or narrow the legal power in the Act; it implements subsection 61(5D) by specifying the kinds of therapeutic goods information that the Secretary may release under subsection 61(5C) (see section 3 and section 5). It operationalises publication choices (who decides: the Secretary) and the data fields to be published (e.g. approval-holder name/contact/ABN — Schedule item 4; packaging images — item 5; hyperlinks to MSII/PBS — items 9 and 11). While it increases the granularity of publicly releasable data (creating practical verification and data-collection tasks for approval holders and administrators), it does not alter the statutory scope of the Secretary’s release power."},"complexity_factors":["Cross-references to multiple Act provisions (authority under s61(5D); release under s61(5C); reliance on approvals under s19A) (see sections 3 and 5 and Schedule items referencing section 19A).","Large set of distinct information types in Schedule 1 (items 1–11) requiring different data formats: names, strengths, registration numbers, ABNs, contact numbers, images, batch and expiry data, hyperlinks.","Dependency on external data sources/databases (Medicine Shortages Information Initiative and Pharmaceutical Benefits Scheme) for hyperlinks or confirmations of absence (Schedule items 9 and 11).","Operational/administrative burdens to collate, verify and publish detailed packaging, supply and approval-period information (Schedule items 5, 10 and 7–8).","Delegated instrument form and commencement mechanics (delegate-made under subsection 61(5D); specific commencement clause) increases technical drafting and implementation considerations (sections 1–3 and clause 2)."],"plain_english_summary":"This specification tells the Therapeutic Goods Administration what kinds of information it may publish about medicine shortages and substitute supplies. It lists specific data the Secretary can release — for example, names of unavailable registered goods, approved substitute products under section 19A, packaging images, contact and ABN details of approval holders, supply status, and hyperlinks to existing databases. It affects approval holders, sponsors and users of medicines by making identified product and supply details publicly available; the Secretary decides what is released."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017","history":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017/history","analysis":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017/analysis","conflicts":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017/conflicts","importantCases":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017/important-cases","documents":"/api/acts/therapeutic-goods-information-approvals-relating-to-medicine-shortages-specification-2017/documents"}}