Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1991 NO. 84

STATUTORY RULES 1991 No. 84

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

ISSUED ON THE AUTHORITY OF THE MINISTER OF STATE FOR AGED, FAMILY AND HEALTH SERVICES

The Therapeutic Goods Act 1989 (the Act) commenced on 15 February 1991.

Section 63 of the Act provides that the Governor-General may make Regulations prescribing the matters set out therein. The Therapeutic Goods Regulations (the principal Regulations) were approved by Parliament on 14 February 1991.

The Therapeutic Goods Regulations (Amendment) (the amending Regulations) introduce several amendments to the principal Regulations which are necessary as a result of commitments given by the Government during the Parliamentary consideration of the principal Regulations; as a result of the need to accommodate in the principal Regulations several practical matters revealed by the operation of the principal Regulations; and as a result of the need for minor drafting changes to clarify some requirements.

Amending Regulation 1 provides for a number of the amending Regulations to be taken to have commenced on 15 February 1991. This ensures that Regulations under the Act do not apply inappropriately from 15 February 1991 and that all applications under the Act received since then are dealt with uniformly. The retrospective nature of the Regulations does not adversely affect the existing rights of any person other than the Commonwealth.

The amending Regulation 2 is a formal provision.

The amending Regulation 3.1 introduces a new subregulation 12(1A) into the principal Regulations to exempt from the Australian Register of Therapeutic Goods, items in Schedule 5A which is introduced by amending Regulation 13.1.

The amending Regulation 4.1 amends paragraph 24(1)(a) of the principal Regulations to permit samples of therapeutic goods to be taken for analysis under the legislation from wholesalers as well as from licensed manufacturers or sponsors. Collection of samples from one point will increase the efficiency of the sampling program.

The amending Regulation 5.1 amends paragraph 45(2)(a) of the principal Regulations to clarify that subregulation 45(2) applies to both drugs and therapeutic devices.

The amending Regulation 5.2 amends subregulation 45(3) of the principal Regulations to extend the scope of the subregulation to allow the Secretary to waive or reduce evaluation fees of therapeutic goods for clinical trials which were accepted for evaluation or were approved for use before the commencement of the Act. This amendment operates retrospectively to the commencement of the Act.

The amending Regulation 6.1 amends the heading of Part 7 of the principal Regulations to refer also to "charges".

The amending Regulation 7.1 introduces a new regulation 45A to accommodate an undertaking given to the Parliament during the Parliamentary consideration of the principal Regulations that in order to lessen the effects of fees and charges on small businesses, the annual licence charge for a manufacturer's licence will be reduced to 50% of that applying otherwise when the annual wholesale turnover of the manufacturer's business is not more than $50,000. This amendment operates retrospectively to the commencement of the Act.

The amending Regulation 8.1 amends subparagraph 46(2)(e)(ii) of the principal Regulations to ensure consistent terminology. "Poisons Standard" is defined in Part 1 of the principal Regulations.

The amending Regulation 9.1 amends regulation 48 of the principal Regulations to permit the minister to delegate powers and functions under regulation 48 to an officer of the Department.

The amending Regulation 10.1 amends Schedule 3, item 3(c) of the principal Regulations to clarify that the accessories referred to in the item are those which are implantable in the body.

The amending Regulation 10.2 amends Schedule 3, item 3(9) of the principal Regulations to extend the range of devices of human and animal origin which are not required to be registered. The excluded devices therefore are listable devices. This amendment operates retrospectively to the start of the legislation.

The amending Regulation 11.1 amends Schedule 4, part 3 of the principal Regulations to include manganese amino acid chelate as a listable substance, otherwise it would be a registrable substance. This amendment operates retrospectively to the start of the legislation.

The amending Regulation 11.2 amends Schedule 4, part 4 of the principal Regulations to correct the entry for Acorus calamis by deleting "Blue flag" as a common name for the herb.

The amending Regulation 11.3 amends Schedule 4, part 4 of the principal Regulations to clarify that herbs not previously used for therapeutic use in Australia are subjected to a closer level of assessment i.e. registration rather than listing.

The amending Regulation 12.1 amends the heading of Schedule 5 of the principal Regulations to refer to subregulation 12(1) of the principal Regulations.

The amending Regulations 12.2 and 12.4 delete items 5 and 10 respectively from Schedule 5 of the principal Regulations. The items are transferred to a new Schedule 5A by amending Regulation 13.1.

The amending Regulation 12.3 amends Schedule 5, item 7(c) of the principal Regulations to clarify the intended scope of the item. It is not intended that the item include complex instruments such as thermometers and sphygmomanometers which could be included by the current wording.

The amending Regulation 12.5 amends Schedule 5, item 11 of the principal Regulations to introduce a drafting revision which clarifies the intent of the item without altering its scope. The item is a transitional provision which retains approvals for supply under previous legislation for 6 months after the commencement of the Act.

The amending Regulation 13.1 introduces Schedule 5A into the principal Regulations. The Schedule contains therapeutic goods exempt from Part 3 of the Act subject to certain conditions. Item 1 of Schedule 5A is expanded from the former item 5 in Schedule 5 to permit clinical trial goods and goods intended for use in the treatment of a patient in urgent situations to be imported and held under the direct control of the sponsor prior to approval for supply for use in humans. Due to the possibility of misuse of this exemption, it is required that the sponsor maintains records, which must be supplied to the Secretary upon request, relating to the source and distribution of the goods subject to subsection 19(1) of the Act. The amendment operates retrospectively to the commencement of the legislation.

The amending Regulation 13.2 includes a new item (item 3) in Schedule 5A of amending Regulation 13.1 which permits the operation of a clinical trial notification scheme as an alternative to the clinical trial exemption scheme which operates under Section 19(1)(b) of that Act. The Government has given a commitment to introduce the notification scheme in order to increase the flexibility of initiating clinical trials in Australia whilst still providing appropriate protection for human subjects participating in the trials.

The amending Regulation 14.1 amends Schedule 7, item 3, of the principal Regulations to extend the exemption to include all components for therapeutic devices from- the need for the manufacturer to be licensed. The Government gave this undertaking during the passage of the principal Regulations through the Parliament. The amendment operates retrospectively to the start of the legislation.

The amending Regulation 15.1 amends Schedule 9, item 2(d)(i) of the principal Regulations to reflect the amendment to paragraph 45(2)(a) (amending Regulation 5.1 refers).

The amending Regulation 15.2 amends Schedule 9, item 12 of the principal Regulations to clarify that the item applies to modifications of the information about a drug, not just a modification to a drug itself.

The amending Regulation 15.3 introduces a new item 14 in Schedule 9 of the principal Regulations to prescribe the fee for notification of a clinical trial subject to item 3 of Schedule 5A.