Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2003 (NO. 4) 2003 NO. 258

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 tighten and enhance existing requirements placed on manufacturers and sponsors to better protect public health and safety in relation to therapeutic goods supplied in, or exported from Australia. The Regulations ensure that the Therapeutic Goods Regulations 1990 (the Principal Regulations) are consistent with amendments to the Act that commenced operation on 27 May 2003; the amendments were made consequent to the failure of Pan Pharmaceuticals Ltd to meet the requirements of good manufacturing practice and the associated difficulties encountered by TGA in quickly identifying affected therapeutic goods for the purposes of recall.

Specifically the Regulations:

•       facilitate the better identification of therapeutic goods for the purposes of recall;

•       enhance compliance with guidelines issued by the TGA for the reporting of adverse reactions to the use of medicines; and

•       ensure that the Principal Regulations are consistent with expanded public notification and recovery requirements recently introduced into the Act.

The Regulations also make other amendments to update and clarify certain provisions of the Principal Regulations, to rectify inadvertent technical oversights made by previous amendments to the Principal Regulations, to extend the range of listable goods consistent with recommendations of the Complementary Medicines Evaluation Committee and to broaden the field of possible membership of the Medicines Evaluation Committee to cover consumer representatives.

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

Details of the Regulations are set out in the Attachment.

Regulations 1 to 3 and Schedule 1 would commence on gazettal. Schedule 2 would commence on 1 October 2004. This allows sufficient time for the implementation of any relabelling of goods to meet the new requirements specified in Schedule 2.

ATTACHMENT

Details of the Therapeutic Goods Amendment Regulations 2003 (No. 4).

Proposed Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods Amendment Regulations 2003 (No. 4).

Proposed Regulation 2 provides for Regulations 1 to 3 and Schedule 1 to commence on gazettal and for Schedule 2 to commence on 1 October 2004.

Proposed Regulation 3 provides for Schedules 1 and 2 to amend the Therapeutic Goods Regulations 1990.

SCHEDULE 1 - Amendments commencing on gazettal.

Proposed Item 1 omits the phrase "(except section 31A and sections 31C to 31F)" and inserts the phrase "(except sections 30EA, 31A and 31C to F)" in subregulation 12(1) of the Therapeutic Goods Regulations 1990 (the Regulations). This proposed amendment would ensure consistency with the intended operation of section 30EA (Public notification and recovery of therapeutic goods) in respect of exempt goods specified in Schedule 5 to the Regulations.

Proposed Item 2 omits the phrase "(except section 31A and sections 31C to 31F)" and inserts the phrase "(except sections 30EA, 31A and 31C to F)" in subregulation 12(1A) of the Regulations. This proposed amendment would ensure consistency with the intended operation of section 30EA in respect of exempt goods specified in Schedule 5A to the Regulations.

Proposed Item 3 omits the word ", exportation" from subregulation 12AB(1) of the Regulations. This amendment would mean that conditions of approval for the use of therapeutic goods solely for experimental purposes, which consist of certain assurances specified in subregulation 12AB(2), would only apply to the importation and supply of the goods and not to the exportation of the goods. This is consistent with the intention that the assurances be Australia-specific and not relate to goods exported from Australia that are intended for use in clinical trials overseas. The TGA has found that assurances provided in relation to exportations are difficult to monitor for compliance and inappropriately place Australia-specific requirements on investigators in other jurisdictions. It is noted that the proposed amendment would not alter the requirement for the Secretary of the Department of Health and Ageing to approve clinical trial products for export, but assurances concerning compliance with Australian requirements for the conduct of such trials overseas would no longer be required.

Proposed Item 4 replaces subregulation 12B(1). New subregulation 12B(1) prescribes medical practitioners engaged in clinical practice in or outside a hospital as a class of medical practitioners to whom an authority may be given under subsection 19(5) of the Therapeutic Goods Act 1989 (the Act) to supply unapproved therapeutic goods for human treatment. New subregulation 12B(1A) provides, in relation to medicines, an exception to the requirement under paragraph 19(6)(aa) for medical practitioners, who can be given an authority under subsection 19(5) of the Act, to obtain the approval of an ethics committee to supply the relevant medicines. The exception applies to a medical practitioner engaged in clinical practice outside a hospital who has demonstrated a lack of access to an ethics committee that could approve the supply of the medicines and who has received an endorsement from a specialist college with established expertise relevant to the use of those medicines. The amendments would rectify the current unintended effect of Regulation 12B that arose from a technical oversight when amendments were made to the regulation by the Therapeutic Goods Amendment Regulations 2000 (No. 7).

Proposed Item 5 inserts a new condition in relation to the registration of therapeutic goods specified in Part 1 of Schedule 10 to the Regulations. A person seeking registration of such therapeutic goods is required to comply with the reporting requirements set out in the publication of the Therapeutic Goods Administration (TGA) entitled 'Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by the Drug Safety and Evaluation Branch' as in force from time to time. The amendment would reinforce the need for sponsors to satisfy adverse reaction reporting requirements to the general benefit of better health and safety for the Australian public. The reporting requirements were first published in January 2003 and industry is familiar with the contents of the reporting requirements, having participated in consultation on them.

Proposed Item 6 has the effect of replacing the reference in subparagraph 42C(1)(a)(iv) to 'the Direct Sellers Association of Australia' (being a body that nominates a person to be one of the four manufacturing/supplier members of the Therapeutic Goods Advertising Code Council) with 'the Direct Selling Association of Australia Inc' to reflect that body's current name.

Proposed Items 7 and 8 omit paragraph 42J(2)(a) and inserts paragraph 42J(2)(ca). The effect of these amendments is to replace the reference to the 'Australian Pharmaceutical Manufacturer's Association' (being a body that may nominate a person to attend meetings of the Therapeutic Goods Advertising Code Council as an observer) with 'Medicines Australia' to reflect that body's current name.

Proposed Item 9 has the effect of replacing the reference in subparagraph 42J(2B)(a) to 'the Federation of Australian Radio Broadcasters' (being a body that may jointly with the Federation of Australian Commercial Television Stations nominate a person to attend meetings of the Therapeutic Goods Advertising Code Council as an observer) with 'Commercial Radio Australia Limited' to reflect that body's current name.

Proposed Item 10 has the effect of replacing the reference in subparagraph 42X(2) to 'The Australia New Zealand Food Authority' (being a body that may nominate a person to attend meetings of the Complaints Resolution Panel as an observer) with 'Food Standards Australia New Zealand' to reflect that body's current name.

Proposed Item 11 has the effect of adding paragraph 42ZZJ(j) that specifies 'consumer representation' as a new field of expertise and experience that the Minister may take into account in deciding whether to appoint a person to be a member of the Medicines Evaluation Committee.

Proposed Items 12, 13 and 14 amend Schedule 1 to the Regulations to add references to 'Australian College of Acupuncturists Ltd', 'The Australian Association of Homotoxicology Incorporated' and 'The Homeopathic Medicine Association Inc.'. The effect of the amendments is that Part 2 (Advertisements) of the Regulations would not apply to members of those bodies.

Proposed Items 15, 16, 17 and 18 amend Schedule 4, Part 3 of the Regulations by adding references to 'Borax', 'Borax pentahydrate', 'Boric acid', 'Magnesium phosphate dibasic trihydrate', 'Molybdenum trioxide' and 'Sodium perborate'. The effect of these amendments is that preparations containing these minerals (or mineral salts) as their therapeutically active ingredients would be eligible for listing in the Australian Register of Therapeutic Goods (the Register) where no contrary provision in item 3 of Schedule 4, Part 1 applies.

Proposed Items 19 and 20 amend Schedule 4, Part 4, Division 2 of the Regulations by adding references to plant material 'Azadirachta indica (Neem)' and 'Trametes versicolor' and qualifications applicable to each material. The effect of these amendments is that preparations containing as their therapeutically active ingredients a herbal substance derived from that plant material would be eligible for listing in the Register where they are consistent with applicable qualifications and no contrary provision in item 3 of Schedule 4, Part 1 applies.

Proposed Items 21, 22, 23 and 24 amend Schedule 4, Part 5, Division 1 of the Regulations by omitting reference to 'Bioflavonoids (except quercetin)' and adding references to 'Calcium sodium caseinate', 'Citrus bioflavonoids extract' and 'Quercetin'. The effect of these amendments is that preparations containing the specified substances as their therapeutically active ingredients would be eligible for listing in the Register where no contrary provision in item 3 of Schedule 4, Part 1 applies. The relevant substances are not subject to any dosage limit and do not require a warning label.

Proposed Items 25 and 27 amend Schedule 4, Part 5, Division 2, Subdivision 2 of the Regulations by adding references to 'Borax', 'Borax pentahydrate', 'Boric acid' and 'Sodium perborate' all with a specified maximum daily dose of '3 mg of boron'. The effect of these amendments is that preparations containing the specified substances as their therapeutically active ingredients would be eligible for listing in the Register where the preparations are supplied with the relevant information about daily dosage and no contrary provision in item 3 of Schedule 4, Part 1 applies.

Proposed Item 26 amends Schedule 4, Part 5, Division 2, Subdivision 2 of the Regulations by adding reference to 'Molybdenum trioxide' with a specified maximum daily dose of '125 µg of molybdenum'. The effect of this amendment is that preparations containing the specified substance as their therapeutically active ingredients would be eligible for listing in the Register where the preparations are supplied with the relevant information about daily dosage and no contrary provision in item 3 of Schedule 4, Part 1 applies.

Proposed Item 28 amends Schedule 4, Part 5, Division 3 of the Regulations by adding reference to 'Calcium sodium caseinate' with the warning 'Derived from cows milk'. The effect of this amendment is that preparations containing the specified substance as their therapeutically active ingredients would be eligible for listing in the Register where it is supplied with a label showing the required warning and no contrary provision in item 3 of Schedule 4, Part 1 applies.

Proposed Item 29 amends Schedule 5, item 9, paragraph (b) of the Regulations by replacing the reference to 'the Australian Red Cross Blood Service' with a reference to 'the holder of a licence to manufacture blood and blood components'. Schedule 5 to the Regulations specifies therapeutic goods that are exempt from the operation of Part 3-2 of the Act which deals with the requirements for registration and listing of therapeutic goods other than medical devices. The effect of this amendment is that any person holding a licence to manufacture blood and blood components, which may include others in addition to the Australian Red Cross Blood Service, will be entitled to the benefit of exemption from the Part 3-2 of the Act.

SCHEDULE 2 - Amendments commencing on 1 October 2004

Proposed Item 1 renumbers the current Regulation 6A as subregulation 6A(1) and inserts new subregulation 6A(2). As a result of an amendment to subsection 3(5) of the Act that took effect on 27 May 2003 the presentation of therapeutic goods is now unacceptable if it is capable of being misleading or confusing as to the identification of the goods, in addition to the content or proper purpose of the goods. Pursuant to paragraph 3(5)(e) of the Act new subregulation 6A(2) is made to provide that the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for recovery purposes. This amendment is designed to assist in redressing the significant difficulties TGA encountered in distinguishing medicines supplied by different manufacturers during the recall of products manufactured by Pan Pharmaceuticals Ltd. The new provisions would enhance TGA's ability to identify products affected by a future recall and monitor sponsors' compliance with product recalls. This provision would not come into effect until 1 October 2004 to allow for a transition period for implementation by sponsors as some sponsors will need to undertake relabelling to satisfy this requirement.