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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1992 NO. 19

STATUTORY RULES 1992 No. 19

Issued by the authority of the Minister for Aged, Family and Health Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Section 63 of the Act provides that the Governor-General may make Regulations for the purposes of the Act. The Act also contains a number of provisions which make specific reference to matters which may be prescribed, or otherwise provided for, by Regulation. Those sections of the Act relevant to the matters contained in the Regulations are sections 17, 20, 26 and 34.

The Therapeutic Goods Amendment Act 1991 (the Amending Act) amended the Act to give effect to a number of recommendations contained in Professor Peter Baume's "Report on the Future of Drug Evaluation in Australia".

The Baume Report was commissioned by the Minister for Aged, Family and Health Services. Peter Baume, Professor and Head of the School of Community Medicine at the University of New South Wales, conducted an inquiry and prepared his report on the question of access to drugs and the reform of the drug evaluation process in Australia. The Report was released on 3 July 1991 by both the Deputy Prime Minister and the Minister for Aged, Family and Health Services and they announced, on behalf of the Government, that Professor Baume's recommendations would all be adopted as a package.

Amongst other things, the recommendations provided for the introduction of time limits within which evaluations of certain drugs must be completed, to meet the Act's objective of timely availability of drugs, and for corresponding fee increases for processing applications that attract time limits. The Amending Act contains enabling provisions for time limits, and classes of therapeutic goods, to be prescribed for the purposes of giving effect to the Baume recommendations.

The amending Regulations amend the Therapeutic Goods Regulations to:

(a)       clarify the operation of Part 2 of the Regulations relating to the control of advertisements made in respect of therapeutic goods, and to effect consequential changes necessary to accommodate changes to the Act made by the Therapeutic Goods Amendment Act 1991;

(b)       clarify who is to be treated as the person in relation to whom goods are registered or listed in the Register where that person changes his/her or its name;

(c)       enable the Secretary to allow a person to adopt alternative labelling, requirements specified by the Secretary for the placement of the Register number when the prescribed placement is impractical;

(d)       introduce time limits within which approval to register certain drugs, or to approve variations to the registration of such drugs, must be processed and completed;

(e)       amend Schedules 3 and 4 of the Regulations to clarify what therapeutic goods are required to be included in the part of the Register for registrable and listable goods;

(f)       amend Schedules 6 and 7 to clarify that certain therapeutic devices (dressings, bandages and similar products), whether imported or locally manufactured, are to be subject to acceptable manufacturing standards;

(g)       in line with Recommendation 39 of the Baume Report, provide for fee increases of 20% for the evaluation of Schedule 10 drugs that attract time limits for the completion of evaluations.

Further details of the Regulations are set out in the attachment.

The new Regulations, except regulation 10, commenced on 1 February 1992. Regulation 10 is to commence on 1 July 1992.

ATTACHMENT

DETAILS OF THE THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides that, except for regulation 10, which is to commence on 1 July 1992, these amending regulations are to commence on 1 February 1992.

Regulations 3, 4 and 5 amend Part 2 of the Therapeutic Goods Regulations (the Regulations), which regulates advertisements in respect of therapeutic goods.

Regulation 4 of the Regulations sets out the professionals and practitioners, some of whom are described by reference to membership with professional associations or bodies, to whom unregulated advertisements about therapeutic goods may be directed. New subregulation 4(2A) is designed to ensure that members of those bodies listed in Schedule 1 of the Regulations will only be covered under this regulation if they have the qualifications and training that are necessary or appropriate for membership of the relevant body.

New Regulation 5A clarifies that advertisements dealing with therapeutic goods to be supplied overseas fall outside the regulatory requirements of Part 2 of the Regulations, except Regulation 7, which enables the Secretary to prevent false or misleading representations being made in an advertisement concerning therapeutic goods. Advertisements for exported goods primarily involve product information contained on the labels of the goods or supplied with the goods.

Regulation 5 seeks to clarify that the reference to "government or government authority" includes a reference to a foreign government or foreign government authority, and that the prohibition against advertisements implying that particular therapeutic goods have been approved or recommended by such an authority would not extend to include any statements to that effect authorised or required by that authority.

New paragraph 6(1)(f) has been inserted to prohibit any advertising of unapproved therapeutic goods that fall within Schedule 5A of the Regulations, or that are supplied under the "Special Access Scheme". Therapeutic goods listed under Schedule 5A are principally those that are being tested in clinical trials, Japanese Encephalitis Vaccine and goods that are held under the direct control of an importer pending approval, if given, for release for general marketing or for release to individual patients granted access to unapproved therapeutic goods. Under the "Special Access Scheme" certain experimental or unapproved drugs or devices may be supplied, in accordance with Regulations 12A and 12B, to certain categories of patients, such as terminally ill patients and other patients as described in subregulations 12A(5) and 12B(2), where appropriately qualified medical practitioners consider this is necessary or appropriate for the treatment of such patients. Advertisements in respect of such goods to the general public is to be prohibited.

Regulation 6 substitutes references to "therapeutic goods" with "drugs" in subparagraph 12B(1)(c)(iv) to maintain consistency with the terminology used in the other provisions in Regulation 12B.

Regulation 7 inserts new subregulation 13(4A) to provide that where a person in relation to whom goods are registered or listed changes his or her name or, as a result of a company amalgamation, acquires a new name, then the "new" person is to be entered in the Register as the person in relation to whom the goods are registered or listed in the Register. A similar amendment to Regulation 22 is effected by Regulation 1.1 to cover situations where persons operating under a manufacturer's licence change their names.

Regulation 8 inserts new subregulation 15(2) to allow the Secretary to vary the labelling requirements set out in subregulation 15(1) in cases where those requirements may be impracticable.

Regulations 9 and 10 insert new Regulations_16A, 16B, 16C, 16D, 16E and 16F under new Part 3A to the Regulations.

These new regulations introduce time limits within which the evaluation of certain drugs, identified in new schedule 10, are to be completed.

New Regulation 16A defines "working day", and sets out the periods that are to be discounted for the purposes of calculating the total number of days within which evaluations of Schedule 10 drugs must be completed in accordance with new Part 3A.

New Regulation 16B requires the Secretary to notify an applicant, within the periods set out in new subregulation 16B(2), whether the applicant's application to register a Schedule 10 drug, or to vary information in the Australian Register of Therapeutic Goods in relation to a Schedule 10 drug, has been accepted or rejected.

New Regulation 16C establishes the time limit for the completion of evaluations of applications, received on or after 1 February 1992, to register goods under the Act. New subregulation 16C(2) provides that the time limit commences on the day the Secretary sends a notification of acceptance or rejection of the application, or the day the fee payable under subsection 24(1) of the Act is paid, whichever is the later day. New subregulation 16C(3) provides that the time limit is to be 255 working days or, in the case of an application relating to a drug that satisfies criteria set out in new subregulation 16C(4) which would allow an abbreviated evaluation to be undertaken, 175 working days.

New Regulation 16D applies to applications to vary information in respect of Schedule 10 drugs contained in the Register, where such applications must be supported by clinical, pre-clinical or bio-equivalence data. The new regulation provides that the time limit within which such applications must be processed and completed is to be 255 working days or, if the drug to be evaluated satisfies the criteria set out in subregulation 16D(4) that will permit an abbreviated evaluation to take place, 175 working days.

New Regulation 16E provides that a failure to complete evaluations within the time limit stated in new Regulation 16D does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury of any kind that is caused by or arises out of the failure.

New Regulation 16F applies to applications to vary information (of a kind described in subregulation 16F(1)) in respect of Schedule 10 drugs contained in the Register, where such applications need not be supported by clinical, pre-clinical or bioequivalence data. In such cases, the variation sought is to take effect unless the Secretary raises an objection to that variation within 45 working days, commencing from the day the application is lodged and the appropriate evaluation fee is paid, whichever is the later day. Where the Secretary does raise an objection, the Secretary is required to decide the application within 30 working days of receipt of the applicant's response to the objection, otherwise the application to vary information is taken to be approved.

Regulation 12 inserts new regulation 43AA which provides that where the Secretary fails to meet the deadline set for completing evaluations of applications to vary information as set out in new Regulation 16D, then the evaluation fee payable by the applicant is to be reduced by 25%. An applicant submitting such applications need only pay 75% of the total evaluation owing at the time of lodging an application. The balance is to be paid upon completion of the evaluation within the time limit set under new Regulation 16D, unless that time limit has not been met.

Subregulations 13.1, 13.4 and 13.7 separate therapeutic devices currently covered by schedule 3 of the Regulations into two parts, Part 1 which includes goods subject to the current fees and level of evaluation and Part 2 which includes goods subject to lower fees because the goods require a lesser degree of evaluation as they belong to classes of goods which have established technology and a history of therapeutic use in humans.

Subregulations 13.2 and 13.3 make consequential adjustments to Item 2 of Schedule 3 of the Regulations to refer to Items in Schedules 5 and 5A which were amended by Statutory Rules 1991 No.84.

Subregulations 13.5 clarifies the articles to be covered by paragraph 3(g)(i) of Schedule 3 of the Regulations.

Subregulations 14.1 and 14.2 make consequential adjustments to Item 2 of Schedule 4 of the Regulations to refer to items in Schedules 5 and 5A which were amended by Statutory Rules 1991 No.84.

Subregulation 14.3 clarifies Item 4 of Part 1 of Schedule 4 of the Regulations so that homoeopathic preparations will not be registrable goods solely because a component more dilute than a 1 thousand fold dilution of a mother tincture is subject to a Schedule of the Poisons Standard.

Subregulations 14.4, 14.5 and 14.6 adjusts entries in Parts 2 and 5 of Schedule 4 of the Regulations relating to listable substances.

Subregulation 15.1 amends Item 1(c) of Schedule 5 of the Regulations to permit the importation of therapeutic goods for personal use in quantities in excess of three months supply if approved by the Secretary under regulation 5 of the Customs (Prohibited Imports) Regulations. This regulation relates to the importation of drugs identified in Schedule 4 of the Customs (Prohibited Imports) Regulations.

Subregulation 15.2 amends Item l(d) of Schedule 5 of the Regulations to cover prescription goods in schedule 8 as well as Schedule 4 of the Poisons standard.

Subregulation 15.3 requires goods being exported for clinical trial purposes to be included in the ARTG as listed goods.

Subregulations 16.1 and 17.1 amend Item 3(c) of Schedule 6 and Item 4(c) of Schedule 7 of the Regulations to ensure that the same products identified in those Items are subject to manufacturing standards whether or not they are imported or locally manufactured goods.

Subregulations 16.2 and 17.2 delete the requirement for antimicrobic susceptibility discs to be subject to manufacturing requirements.

Subregulations 18.1 and 18.9 introduce into Schedule 9 of the Regulations lower application and evaluation fees for therapeutic devices subject to new Part 2 of Schedule 3 of the Regulations, the fees being equivalent to those for registrable nonprescription drugs.

Subregulation 18.2 adjusts the Regulations to take into account changes made by Statutory Rules 1991 No 485.

Subregulations 18.3 to 18.7 increases the fees by 20% in Item 4 of Schedule 9 of the Regulations in accordance with Recommendation 39 of the Baume Report.

Subregulation 18.9 corrects the punctuation in Item 9 of Schedule 9 of the Regulations.

Subregulation 19 introduces a new Schedule 10 in the Regulations which identifies those classes of drugs evaluated by the Drug Evaluation Branch, Therapeutic Goods Administration of the Department, that attract time limits within which evaluations must be completed, in accordance with new Part 3A of the Regulations.