Select Legislative Instrument 2009 No. 142

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1)

The Therapeutic Goods (Charges) Act 1989 (the Charges Act) allows for the imposition of an annual charge on the registration and listing of therapeutic goods, and on the licensing of manufacturers of therapeutic goods, the inclusion of a kind of medical device in the Australian Register of Therapeutic Goods (the Register). The Therapeutic Goods Administration is responsible for administering the Charges Act.

Subsection 5(1) of the Charges Act allows the Governor-General to make regulations, not inconsistent with the Charges Act, prescribing the amounts of annual charges payable.

The Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (the Amendment Act), which commenced on 1 January 2009, repealed subsection 5(3) of the Charges Act. The repealed subsection 5(3) allowed regulations to be made providing for exemption from liability annual charges in respect of the registration or listing of therapeutic goods, or the inclusion of kinds of medical devices in the Register. One particular exemption is set out in the Therapeutic Goods (Charges) Regulations 1990 (the Principal Regulations) and applied where the turnover of particular therapeutic goods or devices is of low volume or low value.

Following the enactment of the Amendment Act, the provisions relating to the exemption to pay applicable annual charges by persons with low value or volume turnover are now implemented under the Therapeutic Goods Act 1989. As a consequence, the requirements relating to the granting of that exemption from payment of applicable annual charges will now be included in the Therapeutic Goods Regulations 1990 which are the subject of a separate Minute. The Amendment Act provides that despite the repeal of subsection 5(3), that subsection also continues to apply after 1 January 2009 in relation to working out whether the annual charges are payable by persons for the financial year beginning on 1 July 2008 and all earlier financial years.

The purpose of the Regulations is to repeal the redundant provisions in the Principal Regulations. The Regulations also provide for the applicable transitional arrangements.

Details of the Regulations are set out in the Attachment.

Interested parties were consulted on a number of proposed changes to the current regulatory framework held in Parliament House during late July and early August 2008. These amendments were discussed during these consultations. These amendments have a nil to low impact on business, individuals and the economy and therefore do not require a regulatory impact statement.

A regulatory impact statement was not prepared as these changes will have no impact on industry.

The Charges Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

The Regulations commence on 1 July 2009.

Authority: Subsection 5(1) of the

Therapeutic Goods (Charges) Act 1989

ATTACHMENT

Details of the Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1)

Regulation 1 names the Regulations as the Therapeutic Goods (Charges) Amendment Regulations 2009 (No. 1).

Regulation 2 provides that the Regulations commence on 1 July 2009.

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

Regulation 4 provides the transitional provision applying to the regulations to be repealed as set out in Schedule 1. It provides that despite the repeal of those regulations, they continue to apply after 1 July 2009 in relation to working out whether the annual charges mentioned in those regulations are payable by a person for the financial year beginning on 1 July 2008 and all earlier financial years.

SCHEDULE 1 –Amendments

Item [1]

Item [1] omits and has the effect of repealing regulations 4B, 4C, 4D, 4E, 4F and 5 of the Principal Regulations. These provisions relate to the granting of an exemption and the cancellation of that exemption from the liability to pay annual charges by a person whose turnover of the relevant goods entered in the Register is low volume and low value. The corresponding provisions prescribing the requirements for the granting of an exemption and the cancellation of that exemption will be set out in the Therapeutic Goods Regulations 1990 (the TG Regulations). This is a consequence of the amendments made to the Therapeutic Goods (Charges) Act 1989 and the Therapeutic Goods Act 1989 by the Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008. Specific requirements such as the granting of an approval for the exemption, the cancellation of an exemption, the making of an application, the criteria for the exemption, the auditing of the granted exemption, and Administrative Appeals Tribunal reviews relating to decisions about the exemption are now to be implemented under section 44A of the Therapeutic Goods Act 1989 and details will be set out in the TG Regulations.