Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2003 (NO. 6) 2003 NO. 361

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 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 minor amendments to the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The Regulations:

-       regularise the appointment of authorised officers and authorised persons under the two sets of regulations;

-       recognise the Tasmanian Therapeutic Goods Act 2001 as corresponding State law;

-       increase the permissible number of consecutive terms for members of the Therapeutic Goods Advertising Code Council and the Complaints Resolution Panel;

-       recognise the change of name for Commercial Television Australia;

-       restore an omission in the description of the power of the Secretary to reduce evaluation fees;

-       make changes to the qualifications for permissible herbal substances in listable medicines for Piper methysticum (Kava); and

-       correct some typographical errors in Schedule 4 of the Therapeutic Goods Regulations 1990.

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 commenced on gazettal.

ATTACHMENT

THERAPEUTIC GOODS AMENDMENT REGULATIONS 2003 (NO. 6)

Regulation 1 names the Regulations as the Therapeutic Goods Amendment Regulations 2003 (No. 6).

Regulation 2 provides that these Regulations commence on gazettal.

Regulations 3 and 4 provide that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the regulations) and that Schedule 2 amends the Therapeutic Goods (Medical Devices) Regulations 2002 (the medical devices regulations).

Schedule 1        Amendments to the Regulations

Item 1 replaces the definition of `authorised person' in regulation 2 with a definition of `authorised officer'. This change and those set out in items 2, 3, 4, 5, 10 and 12, result from legal advice to the effect that the regulations should specifically provide for the declaration of persons as authorised for the purpose of specific provisions of the regulations. The existing regulations refer to `authorised persons' by reference to subsection 3(1) of the Act rather than section 7A. Section 7A has been identified as the proper source for authorising persons to carry out statutory functions. The amendments make the regulations, rather than the Act, the source for authorising persons to carry out particular functions under the regulations. In addition, to standardise the language used in the regulations, persons authorised to carry out particular functions under the regulations would now be referred to as `authorised officers'. Previously the terms `authorised person' and `authorised officer' were both used for this purpose.

Item 2 inserts a new regulation 2A providing for the exercise of power by authorised officers under specified provisions of the regulations, and replaces existing regulation 3 dealing with corresponding State law. The regulations currently declare laws in New South Wales and Victoria to correspond to the Act or the regulations for the purposes of the definition of `corresponding State law' in subsection 3(1) of the Act. The Therapeutic Goods Act 2001 (Tasmania) and the Therapeutic Goods Regulations 2002 (Tasmania) would now also be declared for the purposes of the definition of `corresponding State law' to correspond to the Act and Regulations.

Items 3, 4 and 5 make consequential amendments relating to the new definition of `authorised officer' as described in item 1. Regulation 12B is amended to make it clear that the authorisation in this context is of a different nature and relates to a medical practitioner authorised for the purposes of subsection 19(5) of the Act rather than an officer authorised to carry out functions under the regulations.

Item 6 amends regulation 42D to increase the number of consecutive terms a person holding office as a member of the Therapeutic Goods Advertising Code Council (the Council) can serve from 3 consecutive terms to 4 consecutive terms. The role of the Council is currently under review as part of the development of a new advertising regulatory model. This extension of the term of office is intended to provide for the retention of experienced long serving existing members of the Council during the transition to the new regulatory model.

Item 7 amends regulation 42J dealing with observers to the Council, to recognise the change of name of the `Federation of Australian Commercial Television Stations' to `Commercial Television Australia'.

Item 8 amends regulation 42U to increase the number of consecutive terms a person holding office as a member of the Complaints Resolution Panel (the CRP) can serve from 3 consecutive terms to 4 consecutive terms. The role of the CRP is currently under review as part of the development of a new advertising regulatory model. This extension of the term of office is intended to provide for the retention of experienced long serving existing members of the CRP during the transition to the new regulatory model.

Item 9 amends subregulation 45(1) so that it does not apply to reduction of evaluation fees for goods of a kind mentioned in Part 1 of Schedule 10 of the regulations (prescription medicines). New subregulation 45(4AA) was inserted recently into the regulations to deal specifically with the waiver or reduction of evaluation fees for prescription medicines.

Item 10 deletes the definition of `authorised persons' in regulation 47AA, as described in item 1.

Item 11 amends item 35 of Division 2, Part 4 of Schedule 4 of the regulations in line with recommendations of the Complementary Medicines Evaluation Committee in relation to the conditions of listing for medicines containing kava (Piper methysticum). This amendment is intended to ensure that only the currently known safe forms of kava are used in listed medicines.

Item 12 makes further consequential amendments relating to standardisation of use of the terms `authorised person' and `authorised officer', as described in item 1.

Item 13 includes technical amendments to correct references to column numbers in Schedule 4 that have gone out of alignment due to earlier amendments to that Schedule.

Schedule 2       Amendment to the Medical Devices Regulations

Item 1 replaces the definition of `authorised person' in regulation 10.1 with a new definition. This change, as for those set out in Schedule 1, items 1, 2, 3, 4, 5, 10 and 12 above, results from legal advice to the effect that the regulations should specifically provide for the declaration of persons as authorised for the purpose of specific provisions of the regulations. The existing regulation 10.1 refers to `authorised persons' by reference to subsection 3(1) of the Act rather than section 7A. Section 7A has been identified as the proper source for authorising persons to carry out statutory functions. This amendment makes the regulations, rather than the Act, the source for authorising persons to carry out particular functions under the medical devices regulations.