Commonwealth Numbered Regulations - Explanatory Statements

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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.


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