Commonwealth Numbered Regulations - Explanatory Statements

[Index] [Search] [Download] [Related Items] [Help]


THERAPEUTIC GOODS AMENDMENT REGULATIONS 2004 (NO. 1) 2004 NO. 78

EXPLANATORY STATEMENT

STATUTORY RULES 2004 NO. 78

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

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2004 (No. 1)

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.

Subsection 63 (1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The purpose of the Regulations is to make a number of amendments to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The Regulations are part of the ongoing maintenance of the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. Specifically the Regulations:

•       amend Schedule 4 to the Therapeutic Goods Regulations 1990 to include certain therapeutic goods that have been the subject of listing notices. Under subsection 9A(5) (or its equivalent predecessor provision) of the Act the Minister's delegate has, by notices published in the Gazette (listing notices), required that the goods be included in the Australian Register of Therapeutic Goods (the Register). By virtue of subsection 9A(6) of the Act the listing notices will cease to have effect once the Regulations are made;

•       include additional exemptions from Part 3-2 (Registration and listing of therapeutic goods) and Division 3 of Part 4-11 (Offences relating to medical devices not on the Register) of the Act in specified limited circumstances;

•       make amendments to reflect a change in policy that certain products will be treated as medical devices rather than medicines. The change in policy was adopted following a review by the TGA that included consultation with industry associations and sponsors of the affected products. The change is consistent with the definition of 'medical device' introduced into the Act in October 2002 and with internationally recognised distinctions used in both the European Union and the United States; and

•       correct an incorrect reference and typographical errors.

Details of the Regulations are set out in the Attachment.

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

The Regulations commence on the date of their notification in the Gazette.

ATTACHMENT

DETAILS OF THE THERAPEUTIC GOODS AMENDMENT REGULATIONS 2004 (NO. 1)

Regulation 1 names the Regulations as the Therapeutic Goods Amendment Regulations 2004 (No. 1).

Regulation 2 provides that these Regulations commence on the date of their notification in the Gazette.

Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations)

Regulation 4 provides that Schedule 2 amends the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations).

SCHEDULE 1 - Amendments to the Principal Regulations

Item 1 omits from paragraph 24(1)(a) of the Principal Regulations the second mention of the word "or". This corrects a typographical error.

Item 2 omits from subregulation 47(3) the reference to "subregulation 9AA(3) or 9S(3)" and replace it with "subregulation 9(3)". The rectification of this incorrect reference has become necessary as a consequence of amendments made to the Principal Regulations in December 2003.

Items 3 and 4 updates the item references in the relevant paragraphs of Schedules 3 and 4 to include item 9 of Schedule 5A, added in 2003, as well as the new items to be added to Schedule 5A as described in Item 15.

Items 5 to 14 inserts changes to Schedule 4 of the Principal Regulations, which sets out the types of therapeutic goods that are eligible for listing (listable goods), rather than registration, in the Australian Register of Therapeutic Goods (the Register). "Listable goods" are lower risk therapeutic goods that are subjected to a lower level of scrutiny commensurate with the risk of harm associated with their use. Fees payable for listing these goods in. the Register are also lower than fees payable for the higher risk "registered goods" such as prescription medicines. Under subsection 9A(5) of the Act (which on 4 October 2002 replaced an equivalent predecessor provision - repealed subsection 17(5)) the Minister, or the Minister's delegate, may by notice published in the Gazette (listing notice), require that specified goods be included in the part of the Register for listed goods and specify any applicable conditions. In accordance with subsection 9A(6) of the Act, a listing notice ceases to have effect if the Principal Regulations are amended to require therapeutic goods included in the listing notice to be included in the part of the Register for listed or registered goods. The effect of the items is that the specified therapeutic goods, that have been the subject of listing notices made by the delegate of the Minister, are included in the part of the Register for listed goods. The items also include some minor changes to ensure consistency of referencing and numbering.

Item 15 provides three additional exemptions from the registration and listing requirements applicable to therapeutic goods under Part 3-2 of the Act. Generally all therapeutic goods supplied in Australia must, in accordance with Part 3-2 of the Act, be included in the Register prior to being imported, exported, manufactured in Australia or supplied to the Australian community. Certain limited exemptions to this requirement are provided in the Act and the Principal Regulations to take account of particular circumstances that warrant special treatment. Schedule 5A of the Principal Regulations specifies particular therapeutic goods that are exempt from the usual requirement of inclusion on the Register subject to compliance with specified conditions. Existing exemptions in Schedule SA include therapeutic goods that form part of international sporting teams' medical supplies while they visit Australia, and therapeutic goods carried by foreign military personnel on exercise in Australia. The effect of Item 15 is to extend the list of exemptions in Schedule 5A to include three additional sets of circumstances in which the supply of therapeutic goods not included in the Register is exempt from Part 3-2 of the Act. Specifically the new exemptions relate to therapeutic goods used by international medical evacuation teams (new item 10 of Schedule 5A), therapeutic goods carried by Heads of State or Heads of Government and senior Government officials visiting Australia on official business (new item 11 of Schedule 5A) and therapeutic goods that form part of the medical supplies of ships or aircraft visiting Australia (new item 12 of Schedule 5A). Conditions are imposed in the case of each exemption to ensure that the exemptions do not extend beyond the particular circumstances to which they are intended to apply. Supply of the therapeutic goods is not permissible outside the targeted groups. A record of use is required to be kept by a member of the group. The goods imported must not be prohibited under the Customs (Prohibited Imports) Regulations 1956. The quantity of the goods imported has to be consistent with their proposed use. All relevant goods have to be either used by the group, removed from Australia or destroyed at the end of the visit.

Item 16 substitutes items 9 and 10 of Part 1 of Schedule 10 with a new item 9 only, with the effect that haemodialysis solutions and irrigation solutions are excluded from the requirement to undergo evaluation by the Drug Safety and Evaluation Branch of the TGA. This amendment is necessary because a policy decision has been taken to regulate those therapeutic goods as medical devices rather than as medicines. This decision was taken following the implementation of the new regulatory system for medical devices and a subsequent TGA review of the way it regulates boundary therapeutic goods (that is, goods that can be considered to be either medicines or medical devices depending on the way the manufacturer markets the principal intended action of the goods) including haemodialysis solutions and irrigation solutions. The change is based on the new definition of 'medical device' in the Act and aligns the Australian system, as far as practicable, with internationally recognised distinctions used in both the European Union and the United States. Consultation by TGA with industry associations and sponsors of the affected products indicated broad support for the change. As haemodialysis solutions and irrigation solutions will be regulated as medical devices., the Office of Devices, Blood and Tissues in TGA will perform evaluation of these goods and the amendment is necessary to reflect this change.

Schedule 2 - Amendments to the Medical Devices Regulations

Item 1 amends paragraph (b), item 2.2 of Schedule 4 of the Medical Devices Regulations by replacing 'goods' with 'device'. This provides consistency of language in Schedule 4.

Item 2 provides additional exemptions in Schedule 4 of the Medical Devices Regulations from the requirement to include medical devices in the Register under Division 3 of Part 4-11 of the Act. When the new regulatory system for medical devices was introduced in October 2002 exemption provisions for medical devices, similar to those applying to other therapeutic goods, were included in the Act. The exemptions replicate the three sets of circumstances in which exemptions from the operation of Part 3-2 of the Act apply to therapeutic goods other than medical devices, as set out in Item 15 of Schedule 1 to these Regulations, with appropriate changes consistent with existing exemptions in Schedule 4.


[Index] [Related Items] [Search] [Download] [Help]