Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) AMENDMENT REGULATIONS 2002 (NO. 6) 2002 NO. 345

STATUTORY RULES 2002 No. 345

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

Therapeutic Goods Act 1989

Therapeutic Goods (Charges) Amendment Regulations 2002 (No. 6)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a 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.

Section 18 of the Act and Regulation 12 of the Therapeutic Goods Regulations 1990 (the Principal Regulations) specify that the therapeutic goods currently listed under Schedule 5A to the Principal Regulations are exempt from registration and listing requirements, subject to compliance with the relevant conditions specified in the Schedule.

Inclusion of therapeutic goods in Schedule 5A has enabled the Government to import unregistered goods to create a preparedness for bioterrorist attacks. These exemptions will expire on 31 December this year, but the proposed amendments would enable the goods to continue to be stored for future use in the event of an emergency where the goods continue to be "exempted" under section 18A of the Act.

Section 18A of the Act enables the Minister to exempt therapeutic goods from the usual registration or listing requirements where it is considered to be in the national interest to (a) stockpile those goods in preparation for a potential threat to public health; or (b) those goods are required in response to an actual threat to public health caused by an emergency. Generally, unless therapeutic goods are registered or listed in the Australian Register of Therapeutic Goods or are exempted from the requirement to be so included in that Register, the importation, manufacture or supply of such goods by their sponsors would be unlawful.

The purpose of the Regulations is to make technical amendments to the Principal Regulations to enable specific therapeutic goods, currently exempted, to continue to be made available for stockpiling in preparation for a potential threat to public health caused by an emergency, such as a bioterrorist attack.

Details of the Regulations are set out in the Attachment.

Regulations 1 to 3 and Schedule 1 commence on gazettal. The Regulations set out in Schedule 2 commence on 1 January 2003. The Schedule 2 amendments commence on 1 January 2003 to coincide with the expiry of the exemptions, on 31 December 2002, for goods described in Items 9 and 10 of Schedule 5A.

ATTACHMENT

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

Regulation 1 states that the title of the Regulations will be the Therapeutic Goods Amendment Regulations 2001 (No. 6 ).

Regulation 2 provides that Items 1 to 3 and Schedule 1 of these Regulations will commence from the date of gazettal and Schedule 2 of these Regulations will commence from 1 January 2003.

Regulation 3 provides that the Regulations amend the Thefapeutic Goods Regulations 1990 as provided in Schedules 1 and 2.

SCHEDULE 1- AMENDMENTS

Item 1

Item 1 omits subregulation 12(1D) to take account of Item 11 in Schedule 5A being omitted. Item 11 ceased to apply on 30 June 2002.

Item 2

Item 2 amends subregulation 47(1A) to take account of Item 11 in Schedule 5A being omitted.

Item 3

Item 3 amends Items 9 and 10 of Schedule 5A to the Regulations to make it clear that the exemption ceases on 31 December 2002 unless on that day, there is an exemption under section 18A of the Act that takes effect in relation to the goods immediately after that day.

Item 4

Item 4 deletes Item 11 of Schedule 5A. This exemption ceased to apply on 30 June 2002.

SCHEDULE 2 - AMENDMENTS

Item 1

Item 1 omits subregulation 12(1C). It is intended that Combopen and Atropen Autoinjectors (Item 9 of Schedule 5A of the Regulations) will be made exempt goods under section 18A of the Act from 1 January 2003. Similarly, specified smallpox vaccines are now exempt goods under section 18A of the Act. In view of the proposed exemptions under section 18A, subregulation 12(1C) will be redundant from 1 January 2003.

Item 2

Item 2 omits subregulation 47(1A). From 1 January 2003, Items 9 and 10 cease to be exempt goods under regulations made for the purposes of section 18 of the Act. In view of these amendments subregulation 47(1A) becomes redundant.

Item 3

Item 3 omits Items 9 and 10 of Schedule 5A of the Regulations. The exemptions for the purposes of section 18 cease to apply on 31 December 2002. It is intended that these goods should be covered by an exemption made under section 18A of the Act, from 1 January 2003.