Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 3) 2002 NO. 143

STATUTORY RULES 2002 No. 143

Issued by the authority of the Parliamentary Secretary to the Minister for Health and Ageing

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2002 (No. 3)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 63 of the Act provides that the Governor-General may make Regulations for the purposes of the Act. In particular, the Governor-General may, under subsection 63(1) and paragraphs 63(2)(h) and 63(3)(a) of the Act, make regulations prescribing fees for any matter under the Act or the Therapeutic Goods Regulations 1990 (the Regulations), as well as fees in relation to different classes of therapeutic goods or different steps in the manufacture of such goods.

Schedule 9 of the Regulations provides the list of fees chargeable under the Act. These fees reflect the cost incurred by the TGA in performing the various tasks under the Act and the Regulations.

The purpose of the Regulations is to increase the fees payable under Schedule 9 of the Therapeutic Goods Regulations, which include the processing of applications for registration and listing of therapeutic goods in the Australian Register for Therapeutic Goods (ARTG), the processing of applications for varying the entry evaluation of these goods in the ARTG, and the inspection and licensing of manufacturing premises, by 6.315 per cent; make control material used with diagnostic goods for in vitro purposes registrable therapeutic devices; omit redundant fee items; and add new fee items.

The Regulations increase the fees payable under Schedule 9 of the Therapeutic Goods Regulations by 6.315 per cent to enable the TGA to continue to meet the government's requirement that the TGA operates on a full cost-recovery basis. These fees reflect the cost incurred by the TGA in performing the various tasks under the Act and Regulations. The proposed Regulations now require control material for use with diagnostic goods for in vitro use to be entered into ARTG as registered therapeutic devices. Control material is used to validate the performance of an in vitro diagnostic test and is normally incorporated within an in vitro diagnostic kit. However, occasionally the control material is supplied separately and this amendment allows this control material to be evaluated and entered into the ARTG in its own right. The proposed Regulations also omit redundant fee items and add new fee items relating to control material for use with diagnostic goods for in vitro use and the registration (or variation to entries in the Australian Register of Therapeutic Goods (ARTG)) of implantable therapeutic devices which incorporate or are designed to incorporate an ancillary medicine, where the purpose of the incorporation is to enhance the function of the device.

The 6.315 per cent increase is made up of:

50 per cent annual Wage Cost Index (WCI)................1.75 per cent

50 per cent CPI (annual adjusted)...........................1.55 per cent

increased rent...........................................3.015 per cent

The increased rent is a result of the Government's policy of commercialisation of its special-purpose and industrial estates, which includes the TGA building in Symonston. This led to an increase in the annual rent that must be paid. The increase of $3.317 million is to be phased in over 3 years from 1 July 2002 at the rate of $1.5 million in each of the first two years and the balance in the third year. An increase to both fees and charges of 3.3 per cent is required to fully recover the $1.5 million rental increase in the 2002/2003 financial year. The formula for the 6.315 per cent increase was discussed with all key industry bodies. These are the Australian Self-Medication Industry, the Complementary Healthcare Council, the Medical Industry Association of Australia and the Australian Pharmaceutical Manufacturers Association. The four industry associations have agreed to the formula as the basis for the 6.315 per cent increase to the fees in Schedule 9 of the Therapeutic Goods Regulations 1990.

Details of the Regulations are set out in the Attachment.

The Regulations commence on 1 July 2002.

ATTACHMENT

Details of the Therapeutic Goods Amendment Regulations 2002 (No. 3)

Regulation 1 states that the title of the Regulations will be the Therapeutic Goods Amendment Regulations 2002 (No. 3).

Regulation 2 provides that the Regulations will commence from 1 July 2002.

Regulation 3 provides that the Regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedule 1.

SCHEDULE 1 - AMENDMENTS

Item 1 increases the level of reduced fees that apply in the circumstances set out in regulation 45. A 6.315 per cent increase to the fees payable will now apply under this regulation. Regulation 45 provides the authority to the Secretary to waive or reduce fees payable to the TGA in specified circumstances.

Item 2 inserts control material for use with diagnostic goods for in vitro use in the list of therapeutic goods required to be included in the part of the Australian Register for Therapeutic Goods (ARTG) for registered goods, but which attract lower evaluation fees than registrable devices included in Part 1 of Schedule 3 to the Regulations.

Item 3 amends fee Item 2 in Schedule 9 to specifically exclude implantable therapeutic devices which incorporate or are designed to incorporate ancillary medicines, wherein the purpose of the incorporation is to enhance the function of the device, from fees payable under Item 2 of Schedule 9. This makes it clear that the application fee under Item 3A apply to these devices.

Item 4 inserts new fee items 3A and 3B for the registration and evaluation of implantable therapeutic devices which incorporate or are designed to incorporate ancillary medicinal substances, wherein the purpose of the incorporation is to enhance the function of the device. The application fee applicable for the purposes of paragraph 23(2)(a) of the Act for the registration of these devices is the fee applicable under paragraph 2(c) or 2(d) of Schedule 9. The evaluation fees applicable for the evaluation of the device and the medicinal component of the device are Items 6, 4(b) and 4(c) of Schedule 9, respectively. The Drug Safety and Evaluation Branch of TGA will be involved in the evaluation of the medicinal component.

Item 5 inserts a new fee Item 7AA for the evaluation of data submitted in support of a change to a therapeutic device to which Item 5 of Part 1 of Schedule 3 applies. Item 5 of Part 1 of Schedule 3 to the Regulations relates to implantable therapeutic devices which incorporate or are designed to incorporate ancillary medicinal substances, wherein the purpose of the incorporation is to enhance the function of the device. New fee Item 7AA provides that the fee for evaluation of data submitted in support of a change to the implantable therapeutic device within the scope of Item 5 of Part 1 of Schedule 3 are the following:

•       where the evaluation involves the review of the device (not including the medicinal component of the device, then the fee applicable under Item 7 applies;

•       where the evaluation involves the review of the medicinal component of the device, then the fees applicable under paragraphs 4(c), 4(d) and 7(d) apply.

•       where the evaluation involves the review of the device, including the medicinal component of the device, then the fees applicable under paragraphs 4(b) and 4(c) and Item 7 apply.

Item 6 inserts a fee under Item 5A to apply to control material for use with diagnostic goods for in vitro use to cover the cost of evaluating these products.

Item 7 excludes implantable therapeutic devices which incorporate or are designed to incorporate ancillary medicinal substances wherein the purpose of the incorporation is to enhance the function of the device, from the description of devices set out under fee Item 6 of Schedule 9. This makes it clear that the evaluation fees under Item 3B apply to these devices.

Item 8 excludes implantable therapeutic devices which incorporate or are designed to incorporate ancillary medicinal substances, wherein the purpose of the incorporation is to enhance the function of the device, from the description of devices set out under fee Item 7 of Schedule 9. This makes it clear that the fees payable for a variation to the entry in the ARTG in relation to these devices will be the new fees set out in Item 7AA.

Item 9 omits Item 9A of Schedule 9 to the Regulations as this is no longer relevant. Item 9A relates to the fee for the evaluation of therapeutic goods under relevant sections of the Act, in respect of the evaluation of steps in the manufacture of therapeutic goods, by reference to data in relation to premises where manufacture of the goods takes place, being data contained in a file known as the plant master file. TGA no longer rely on written material provided by manufacturers known as the plant master file for the purposes of Good Manufacturing Practices (GMP) requirements under the Act. For the purposes of GMP audits, TGA now carries out on -site audits, and relies on GMP certificates and/or GMP inspection reports from recognised regulatory authorities from countries in which manufacturing of the therapeutic goods is located.

Item 10 omits Item 15 of Schedule 9 to the Regulations as the same fee reduction is already provided for in regulation 45. Regulation 45 provides the authority to the Secretary to waive or reduce fees payable to the TGA in specified circumstances.

Item 11 increases all the fees in Schedule 9 by 6.315 per cent.