Therapeutic Goods Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B00410 Regulations Not in force Legislative Instrument

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Therapeutic Goods Regulations (Amendment) 1992 No. 89

EXPLANATORY STATEMENT

STATUTORY RULES 1992 No. 89

Issued by authority of the Minister for Aged, Family and Health Services

Therapeutic Goods Act 1982

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Sections 6, 17, 18, 26, 34 and 61 of the Act relevantly provide that the Governor-General may make regulations, not inconsistent with the Act, in respect of the following matters:

(a) subsection 6(3) - prescribing laws of a State or Territory which can operate concurrently with the Act;

(b) paragraph 17(4)(a) - prescribing the therapeutic goods to be included in the relevant part of the Register designed for registrable or listable goods;

(c) subsection 18(1) - prescribing the therapeutic goods which are exempt from the requirements of Part 3 of the Act, including the need to be included in the Register;

(d) paragraph 26(1)(g) - prescribing imported therapeutic devices that are to be subject to scrutiny for manufacturing and quality control procedures to establish suitability for inclusion in the Register;

(e) paragraph 26(1)(k) - prescribing quality and safety criteria for specified therapeutic goods subject to listing in the Register;

(f) subsections 34(1) and (2) - prescribing therapeutic goods and persons respectively that are to be exempt from the requirement to be manufactured under a licence or to hold a licence for the purposes of Part 4 of the Act;

(g) subsection 61(8A) - prescribing the fee in relation to requests for information relating to therapeutic goods included in the Register.

The amendments effect changes primarily to the Schedules of the Therapeutic Goods Regulations to clarify the operation of, or intention behind, the various provisions or items contained in those Schedules, as described in more detail in the Attachment.

The amending regulations amend the Therapeutic Goods Regulations to:

(a) include two more professional bodies in Schedule 1 for the purpose of exempting the bodies from the requirements for advertising contained in Part 2 of the Therapeutic Goods Regulations;

(b) clarify therapeutic goods or classes of therapeutic goods covered by Schedules 3 (registered goods), Schedule 4 (listed goods) and Schedule 5 (exempt goods). A new item dealing with kits containing a number of therapeutic items is introduced into Schedule 4;

(c) prescribe quality and safety criteria for certain therapeutic devices included in Schedule 6. The criteria are included in a new Schedule 11;

(d) introduce some changes to Schedule 7 (goods exempt from licensing) and Schedule 8 (persons exempt from licensing);

(e) introduce fees in Schedule 9 for providing information from the Register.

Further details of the Regulations are set out in the Attachment.

The new Regulations are to commence on gazettal.

ATTACHMENT

DETAILS OF THE THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides that these amending regulations are to commence on gazettal.

Regulation 2 amends regulation 3 of the Therapeutic Goods Regulations (the Regulations), by identifying two further enactments from Queensland that may operate concurrently with the Act.

Regulation 3 introduces an interpretation of a kit, for the purpose of a new item introduced into Part 1 of Schedule 4 by subregulation 9.1. Items which are, for example, in a composite pack but are not intended to be a kit can be declared to be not subject to the regulation.

Regulation 4 introduces an interpretation of a 'powered' therapeutic device for the purposes of item 7 in Schedule 5.

Regulation 5 establishes a new Schedule 11 (regulation 17) which contains quality and safety criteria for certain therapeutic devices included in Schedule 6 (subregulation 12.1 refers).

Regulation 6 corrects the references to the paragraphs in subregulations 22(5), (6) and (8) of the Regulations.

Regulation 7 clarifies that subitem 3(g) of Schedule 3 includes components of devices as well as complete devices.

Regulation 8 includes in Schedule 1, for the purposes of exemption from the advertising requirements of Part 2 of the Regulations, two further professional bodies of health care practitioners.

Subregulation 9.1 introduces a new item dealing with kits, which will require these goods to be listed in the Register.

Subregulation 9.2 clarifies that therapeutic goods containing a herbal substance not previously used for therapeutic use in Australia would be registrable rather than listable.

Subregulation 10.1 is an editorial change to item 7 in Schedule 5 to clarify that each of the devices under that item are exempted from the operation of Part 5 of the Act.

Subregulations 10.2 to 10.11 clarify and amend several of the subitems under item 7 of Schedule 5.

Subregulations 11.1 and 11.2 are editorial corrections to Schedule 5A.

Subregulation 11.3 clarifies that the sponsor referred to in item 3 of Schedule 5A refers to a corporation as well as a person.

Regulation 12 introduces quality and safety criteria to apply to the articles in item 3, paragraph (c) of Schedule 6.

Regulation 13 exempts in Schedule 7, bulk liquified medical gases and certain blood products from the need to be manufactured by a licensed manufacturer.

Regulation 14 deletes from Schedule 8 the exemption for persons manufacturing blood products because this kind of manufacture is now exempted by the new item in Schedule 7 introduced by regulation 13.

Regulation 15 establishes fees in Schedule 9 for providing information upon the request of a person from the Register.

Regulation 16 introduces into Schedule 10, two more therapeutic categories which are dealt with by the Drug Evaluation Branch of the Department. There are prescribed time limits for the completion of the evaluation of these products.

Regulation 17 introduces a new Schedule 11 which identifies the quality and safety criteria which apply to therapeutic devices identified in subregulation 12.1.

 

Overview

The Therapeutic Goods Regulations (Amendment) 1992 No. 89, issued by authority of the Minister for Aged, Family and Health Services, was enacted to address gaps and clarify provisions within the Therapeutic Goods Act 1989. The Act aims to establish and maintain a national system of controls regarding the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The regulations amend various schedules to achieve this objective by introducing new items, clarifying existing ones, and introducing fees for information requests related to therapeutic goods included in the Register. These amendments aim to improve the regulation of therapeutic goods by ensuring that the requirements and exemptions are clearly defined and appropriately enforced. The amendments primarily focus on updating and clarifying the schedules of the Therapeutic Goods Regulations to better reflect the intent and operation of the provisions. For example, the regulations introduce two additional professional bodies exempt from advertising requirements, clarify the types of therapeutic goods covered under different schedules, and prescribe quality and safety criteria for certain therapeutic devices. Additionally, the regulations introduce fees for providing information from the Register and make several editorial and clarification changes to various schedules to ensure consistency and accuracy in the application of the Act. These amendments are designed to enhance the effectiveness of the regulatory framework for therapeutic goods in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods used in or exported from Australia, aiming to regulate their quality, safety, efficacy, and timely availability. It encompasses a broad range of goods, including medicines, medical devices, blood, and tissues. The Act applies to entities such as manufacturers, importers, and sponsors who are involved in the supply chain of therapeutic goods within Australia. Certain therapeutic goods and activities are exempt from the requirements of the Act, such as those specified in the Register of Therapeutic Goods, or those exempted through specific regulations. The Act’s application extends across the Commonwealth, with regulations being made by the Governor-General under specified sections of the Act. These regulations can further clarify or modify the scope of the Act, including through the introduction of fees for accessing information from the Register. The Therapeutic Goods Regulations (Amendment) 1992 No. 89, for instance, include changes to the Schedules to better define the application of the Act, such as clarifying the definition of therapeutic kits and introducing quality and safety criteria for certain devices.

Key Provisions

The Therapeutic Goods Regulations (Amendment) 1992 No. 89 primarily revises the Therapeutic Goods Regulations to clarify the operation of various provisions and items within the existing schedules. These amendments, as outlined in the explanatory statement, include several key changes: firstly, the inclusion of two additional professional bodies in Schedule 1 to exempt them from advertising requirements under Part 2 of the Therapeutic Goods Regulations (subregulation 8). Secondly, the clarification of therapeutic goods or classes of goods covered by Schedules 3, 4, and 5, with a new item introduced in Schedule 4 for kits containing multiple therapeutic items (subregulation 9.1). Thirdly, the introduction of quality and safety criteria for certain therapeutic devices in Schedule 6, detailed in a new Schedule 11 (regulation 17). Fourthly, changes to Schedules 7 and 8, which list goods and persons exempt from licensing requirements (regulations 12, 13, and 14). Lastly, the introduction of fees for providing information from the Register in Schedule 9 (regulation 15). These amendments impose several obligations on the parties and entities governed by the Therapeutic Goods Regulations. Firstly, they require professional bodies specified in Schedule 1 to adhere to advertising regulations set forth in Part 2 of the Regulations, unless they are exempt (subregulation 8). Secondly, they mandate that certain therapeutic goods or classes of goods be included in the appropriate schedules (Schedules 3, 4, and 5) and that any kits containing multiple therapeutic items be listed in the Register (subregulation 9.1). Thirdly, they necessitate that therapeutic devices listed in Schedule 6 meet the quality and safety criteria set out in the new Schedule 11 (regulation 17). Fourthly, they require goods and persons listed in Schedules 7 and 8 to comply with specific exemptions from licensing requirements (regulations 12, 13, and 14). Lastly, they impose a fee for providing information from the Register, as detailed in Schedule 9 (regulation 15). The Therapeutic Goods Regulations (Amendment) 1992 No. 89 includes provisions that outline potential penalties for non-compliance. Although specific maximum penalties are not detailed in the explanatory statement, it is implied that breaches of the regulations could result in civil or criminal consequences. For example, non-compliance with advertising requirements could result in legal action against the offending party. Similarly, failure to list certain goods in the Register or meet quality and safety criteria could lead to penalties under the Therapeutic Goods Act 1989. Additionally, failure to adhere to licensing exemptions or to pay the prescribed fees could result in enforcement actions, including fines or other civil penalties. It is important for entities and individuals governed by these regulations to ensure full compliance to avoid any potential legal repercussions.

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