Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 NO. 398

STATUTORY RULES 1997 No. 398

Issued by Authority of the Minister for Health and Family Services

Therapeutic Goods Act 1989

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 are exported from Australia. The Therapeutic Goods Administration (the TGA) has the responsibility of administering the Act.

Section 63 of the Act provides that the Governor-General may make Regulations prescribing, amongst other things, matters necessary or convenient for carrying out or giving effect to the Act.

Paragraphs 63(2)(c) and (g) and 63(3)(b) of the Act prescribe requirements for the advertising of therapeutic goods, fees for the evaluation of data concerning therapeutic goods or the inspection of manufacturing operations, and providing for the refund, reduction or waiving of fees or charges in cases identified in the Regulations.

Paragraphs 17 (4)(a) and (b), and subsections 18(1) and (3) of the Act prescribe the classes of therapeutic goods Which are to be included in each part of the Australian Register of Therapeutic Goods (ARTG), transferred from one part to the other, exempted from inclusion or included by revocation of an exemption.

Paragraph 26 (1)(g) of the Act prescribes what devices are required to meet manufacturing and quality control procedures where they are imported into Australia.

Subsections 34(1) and (3) of the Act prescribe the classes of therapeutic goods exempt from being manufactured by a licenced manufacturer and revoking such exemptions.

Accordingly, the Regulations:

(a)        make a number of minor and machinery changes to correct certain identified inconsistencies and incorrect references currently in the Regulations, and update some definitions (Regs 2, 3, 5, 6, 7, 8, 9. 1, 10, 11);

(b)        provide that reduced application fees may apply to low level registrable devices in certain circumstances (Regs 4.2, 4.3, 4.4, 4.5, 13.1);

(c)        include new fee categories for the evaluation of software and for the confirmatory evaluation of overseas reports and data (Regs 4.1, 13.2, 13.3, 13.4);

(d)        exempt manufacturers of medical devices from the requirement to be licensed where the only act of "manufacture" is to relabel the product to comply with the labelling requirements of the Standard for the Uniform Scheduling of Drugs and Poisons (Reg 12);

(e)        clarify that bench top and portable sterilisers are not excluded from the requirement to be listed on the ARTG (Reg 9.2);

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

The Regulations commence on the date of Gazettal.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 states that the Therapeutic Goods Regulations are amended as set out in these amending Regulations, and will commence on gazettal.

Regulation 2 (Interpretation)

Subregulations 2.1 and 2.2 update the existing definitions of "active implantable therapeutic device" to make it clear that the accessories used with the device form part of the device; and "diagnostic goods for in vitro use" to align it with the European Union definition, as part of TGA's move towards harmonisation of Australian and European requirements.

Regulation 15 (Application of registration or listing number to goods)

Subregulation 3.1 corrects a mistake in the Regulations by inserting a corrected reference in subregulation 15(1) to paragraph 20(2)(a) of the Act (the current reference is to paragraph 20(2)(d) of the Act, which does not exist)

Regulation 45 (Waiver or reduction of fees)

Subregulation 4.1 adds "software" as one of the matters for which a reduced fee for an application involving evaluation may apply, when an application is made to register a therapeutic device.

Subregulations 4.2, 4.3, 4.4 and 4.5 amend the provisions that provide for a reduced application fee to be paid in relation to multiple applications to register therapeutic devices included in Part 1 of Schedule 3 that require evaluation. The amendments take into account that applications for the evaluation of "software" may also qualify for reduced fees.

Schedule 1 (Part 2 does not apply to members of an Australian branch of one of these bodies)

Subregulation 5.1 inserts new item 17B into Schedule 1, adding the International Christian Association of Natural Therapists Ltd (ICANT) as a body whose members are not subject to the provisions of Part 2 of the Regulations, which relate to restrictions on advertising.

Schedule 2 (Prohibited and required representations for the purposes of paragraphs 6(1) (a) and (b))

Subregulation 6.1 clarifies that the required representation in relation to vitamin preparations, provided for in Item 1, Part 2 of Schedule 2, is only necessary when the vitamin preparations are for oral ingestion.

Schedule 3 (Therapeutic goods required to be included in the part of the Register for Registered Goods)

Subregulation 7.1 deletes item 1 of Part 2 of Schedule 3. This currently requires that bradycardia pacemakers and leads to which a Therapeutic Goods Order (TGO) made under subsection 10(1) of the Act applies, be registered. There has never been a TGO introduced for bradycardia pacemakers, which have now been overtaken by newer technology. As it is therefore unlikely that there will be any more applications for the registration of bradycardia pacemakers there is no need to develop a TGO for them, and this item is therefore redundant.

Subregulations 7.2 and 7.3 correct item 5 of Part 2 of Schedule 3 by clarifying that the item refers to both instrument grade disinfectants and sterilants which make certain therapeutic claims ' rather than just instrument grade disinfectants. A minor punctuation change is also made.

Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)

Subregulation 8.1 clarifies that custom made devices are exempt from being listed on the Australian Register of Therapeutic Goods (ARTG), by inserting a reference to item 5 of Schedule 5 into Item 2(b) of Part 1 of Schedule 4. This reference had been inadvertently omitted previously.

Subregulation 8.2 updates the reference in item 7 of Part 1 of Schedule 4 to refer to the most current standard for the testing of sun protection factor for sunscreen preparations.

Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

Subregulation 9.1 deletes Item 7, subparagraph (b)(iv) from Schedule 5. This is a reference to in vitro diagnostic goods used for the diagnosis of HIV or Hepatitis C. These are now registrable goods and are included in Part 2 of Schedule 3. The reference to them in Schedule 5, which lists therapeutic goods exempt from the requirement to be listed or registered, is therefore inconsistent.

Subregulation 9.2 amends item 7(e) of Schedule 5 to also provide that bench top and portable sterilisers (that are not permanently plumbed or wired) used for the sterilisation of medical and dental instruments are not exempt from the operation of part 3 of the Act.

Subregulation 9.3 updates the reference in subparagraph g (i) of item 8 of Schedule 5 to refer to the most current standard for the testing of sun protection factor for sunscreen preparations.

Schedule 6 (Therapeutic goods prescribed for the purposes of paragraph 26(1) (g) of the Act)

Subregulation 10.1 deletes Item 3, subparagraphs (t) (iii) and (iv) from Schedule 6. This is a reference to in vitro diagnostic goods used for the diagnosis of HIV or Hepatitis C. These are now registrable goods and are included in Part 2 of Schedule 3. The reference to them in Schedule 6, relating to listable devices, is therefore inconsistent.

Subregulation 10.2 deletes Item 5 from Schedule 6. Item 5 enables the Secretary to refuse to fist certain imported hospital grade disinfectants on the ARTG where manufacturing and quality control procedures undertaken overseas are considered unacceptable. However, licensing and manufacturing requirements for these imported products have not been resolved and are currently the subject of consultation with industry. This item should therefore not be in operation.

Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)

Subregulation 11.1 deletes Item 4, subparagraphs (g) (iii) and (iv) from Schedule 6. This is a reference to in vitro diagnostic goods used for the diagnosis of HIV or Hepatitis C. These are now registrable goods and are included in Part 2 of Schedule 3. The reference to them in Schedule 7, which exempts products from manufacturing controls, is therefore inconsistent

Subregulations 11.2 and 11.3 correct an inconsistency in relation to Items 13, 20, 21 and 22 of Schedule 7. Currently, Item 13 provides that all disinfectants are exempt from the operation of Part 4 of the Act (relating to manufacturing standards), and items 20, 21 and 22 also specify that certain types of disinfectants are exempt, but not other classes of disinfectants. The intention was that only instrument grade disinfectants used on critical or semi-critical medical devices should be exempt. The proposed Subregulations therefore delete items 20, 21 and 22 and clarify item 13 to achieve this intention.

Schedule 8 (Persons exempt from the operation of Part 4 of the Act)

Subregulation 12.1 adds new Item 6 to Schedule 8 to exempt manufacturers of therapeutic devices from the requirement to be licensed where the only act of "manufacture" is to relabel the product to comply with the labelling requirements of the Standard for the Uniform Scheduling of Drugs and Poisons. There are only a few devices subject to poisons scheduling, and therefore required to be relabelled. It is not intended to require licensing of manufacturers who only relabel, however as relabelling is an act of "manufacture" under subsection 3(1) of the Act this clarification has been made.

Schedule 9 (Fees)

Subregulation 13.1 adds new subparagraphs (h)(i) and (ii) to Item 2 of Schedule 9 which set out reduced application fees to apply in certain circumstances for applications to register low level registrable devices (those mentioned in Part 2 of Schedule 3). The circumstances are that more than one application is lodged at the same time and the information lodged in support of the multiple applications is sufficiently common to allow simultaneous evaluations.

Subregulation 13.2 sets out a fee for the initial evaluation of software which is part of a therapeutic device.

Subregulation 13.3 inserts new Item 6AC to Schedule 9. This item introduces new fees for the confirmatory evaluation of overseas reports or data for new and subsequent applications to register devices under section 25 of the Act.

Subregulation 13.4 inserts a new paragraph (ca) to Item 7 to set out a fee for the evaluation of changes to software in therapeutic devices already included in the Register.