You are here

TGC meeting 22, 11 August 2003

Therapeutic Goods Committee

11 August 2003

Meeting report

How to access a pdf document

TGC 22nd meeting (11 August 2003) report (pdf,74kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 22nd Meeting held on 11 August 2003. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.

TGC subcommittees

  1. The Therapeutic Goods Committee establishes a Subcommittee on Blood and Tissues.
  2. The Subcommittee is to provide a draft Therapeutic Goods Order specifying standards for:
    • Haematopoietic stem cells harvested from placental cord blood; and
    • Haematopoietic stem cells harvested from sources other than placental cord blood,
    for consideration by the Therapeutic Goods Committee at its next Meeting.
  3. The Subcommittee is to be Chaired by Associate Professor Rawlinson and have an appropriate membership drawn from experts in this field.
  1. The Therapeutic Goods Committee establishes a Subcommittee on Child-Resistant Packaging.
  2. The Subcommittee is to advise the Therapeutic Goods Committee on:
    • Forms of child-resistant packaging not covered by the existing Therapeutic Goods Orders;
    • The newly introduced British Standard (BS 8404:2001) Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for pharmaceutical products and other relevant international standards; and
    • Issues of concern to injury prevention agencies or health departments related to the child-resistant packaging of therapeutic goods.
  3. The Subcommittee is to be Chaired by Associate Professor Holley and have an appropriate expert membership.

Top of page

Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines

  1. The Therapeutic Goods Committee notes that the new Therapeutic Goods Administration document, Mandatory Advisory Statements for Medicine Labels, will contain the warning statements transferred from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), as well as advisory statements from other sources such as the Therapeutic Goods Regulations.
  2. The Therapeutic Goods Committee recommends the following amendments to Therapeutic Goods Order No. 69 General requirements for labels for medicines, and that these amendments be implemented with effect from 1 July 2004:

    • Amend the definition of 'warning statements' contained in clause 2(1) Interpretation of Therapeutic Goods Order No. 69, to read

      'warning statements' means:
      1. any labelling requirements specified in the Mandatory Advisory Statements for Medicine Labels;
      2. any warning statements specified in the standard that applies to the goods;
      3. a warning statement where incorrect route or method of administration may be hazardous;
      4. any warnings required by the Secretary, Department of Health and Ageing to be included as a condition of Registration/Listing in relation to the goods;
    • Insert, immediately before clause 1 Application and exemptions, the following heading and paragraphs:

      Introduction

      The purpose of a medicine label is to provide information about the product such as its identity, potency, content, storage, expiry date, registration status and distributor. Medicine labels also include other information not required by the Order, but which may be required by other legislative instruments or for commercial purposes. These include items such as signal headings (eg. prescription only, pharmacist only), bar codes and sponsor's logos.

      For non-prescription medicines, the aim is that the information on the label is presented in such a way that consumers can:
      1. choose an appropriate medicine on their own;
      2. use the medicine safely and effectively;
      3. readily find the information they need, understand it and act on it; and
      4. access further information, if they want to know more about the medicine.
      Although there may be various means of achieving the aim stated above, products with labels that have been designed in accordance with the industry Code of Practice entitled [title of the industry code to be inserted]1 and published by [publication details to be inserted]2 will be taken to achieve this aim.

      The mandatory aspects of this Order for all medicines are contained in clauses 1- 7 inclusive and the Schedules to the Order.

1 Expected title is "Designing Medicine Labels for People - A Code of Practice for Developing Usable Labels for Non-Prescription Medicines"
2 To be published by the Communication Research Institute of Australia

Top of page

Adoption of standards for tamper-evident packaging of therapeutic goods

The Therapeutic Goods Committee recommends that the publication Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods3 be adopted through a Therapeutic Goods Order as a standard in Australia for therapeutic goods, with effect from 1 January 2004 and with a 12-month implementation period from 1 January 2004 for full compliance.

3 Available on the TGA website at www.tga.gov.au

Review of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56)

  1. The Therapeutic Goods Committee:
    • Notes those issues raised by stakeholders in relation to the proposed review of Therapeutic Goods Order No. 56 (TGO 56) General standard for tablets, pills and capsules; and
    • Establishes a Subcommittee on General Standards for Tablets, Pills and Capsules to consider those issues in detail and the continued relevance of a general standard for tablets, pills and capsules.
  2. The Subcommittee is to undertake a review of TGO 56, taking into account:
    • Changes in the British Pharmacopoeia since TGO 56 was gazetted;
    • Characteristics of, and regulatory arrangements for, prescription, non-prescription and complementary medicines; and
    • Relevant international standards, and
    provide a report to the first meeting of the Therapeutic Goods Committee in 2004.
  3. The Subcommittee is to be Chaired by Professor O'Donnell and have an appropriate expert membership, supplemented with relevant industry representation.

Top of page

Amendment to Therapeutic Goods Order No. 70 Standards for export only medicine

The Therapeutic Goods Committee recommends that Therapeutic Goods Order No. 70 Standards for export only medicine be amended to replace the reference to United States Pharmacopeia 25th edition with reference to United States Pharmacopeia 26th edition.

Standard for haematopoietic stem cell (HSC) products

The Therapeutic Goods Committee notes:

  • Progress in the development of a therapeutic goods order as a standard in Australia for haematopoietic stem cells; and
  • That the draft Therapeutic Goods Order will be referred to the next meeting of the Committee for consideration.

Update on medical device standards

The Therapeutic Goods Committee notes:

4 Available on TGA website at Standards orders and medical devices
5 Available on TGA website at Standards orders and medical devices
6 See Attachment 1 and Attachment 2

Top of page

Attachment 1: Documents adopted as Australian Standards - Round 1 - June 2002

Australian Standard Reference Title ISO/IEC/CEN/CENELEC Equivalent
AS ISO 9703.1-2002 Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals ISO 9703-1:1992
AS ISO 9703.2-2002 AS ISO 9703.2-2002 Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals ISO 9703-2:1994
AS EN 540-2002 Clinical investigation of medical devices for human subjects EN 540:1993
AS ISO 14155-2002 Clinical investigation of medical devices ISO 14155:1996
AS ISO 11135-2002 Medical devices - Validation and routine control of ethylene oxide sterilization ISO 11135:1994
AS ISO 11137-2002 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization ISO 11137:1995
AS EN 556.1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001
AS EN 724-2002 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices EN 724:1994
AS EN 1060.1-2002 Non-invasive sphygmomanometers - Part 1: General requirement EN 1060-1:1995
AS EN 1060.2-2002 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers EN 1060-2:1995
AS EN 1174.1-2002 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements EN 1174-1:1996
AS EN 1174.2-2002 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance EN 1174-2:1996
AS EN 1174.3-2002 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques EN 1174-3:1996
AS EN 1640-2002 Dentistry - Medical devices for dentistry - Equipment EN 1640:1996
AS EN 1641-2002 Dentistry - medical devices for dentistry - Materials EN 1641:1996
AS EN 1642-2002 Dentistry - Medical devices for dentistry - Dental implants EN 1642:1996
AS ISO 7376.1-2002 Laryngoscopic fittings - Part 1: Conventional hook-on type handle blade fittings ISO 7376-1:1994
AS ISO 7376.2-2002 Laryngoscopic fittings - Part 2: Miniature electric lamps - Screw threads and sockets for conventional blades ISO 7376-2:1997
AS ISO 7376.3-2002 Laryngoscopic fittings - Part 3: Fibre-illuminated re-usable rigid laryngoscopes ISO 7376-31996
AS ISO 8185-2002 Humidifiers for medical use - general requirements for humidification systems ISO 8185:1997
AS ISO 10535-2002 Hoists for the transfer of disabled persons - Requirements and test methods ISO 10535:1998
AS ISO 10555.1-2002 Sterile, single-use intravascular catheters - Part 1: General requirements ISO 10555-1:1995
AS ISO 10993.1-2002 Biological evaluation of medical devices - Part 1: Evaluation and testing ISO 10993-1:1997
AS ISO 10993.3-2002 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:1992
AS ISO 10993.4-2002 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood ISO 10993-4:1992
AS ISO 10993.5-2002 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-5:1992
AS ISO 10993.6-2002 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation ISO 10993-6:1994
AS ISO 10993.9-2002 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products ISO 10993-9:1999
AS ISO 10993.10-2002 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization ISO 10993-10:1995
AS ISO 10993.11-2002 Biological evaluation of medical devices - Part 11: Tests for systematic toxicity ISO 10993-11:1993
AS ISO 10993.12-2002 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials ISO 10993-12:1996
AS ISO 10993.13-2002 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices ISO 10993-13:1998
AS ISO 10993.16-2002 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables ISO 10993-16:1997
AS/NZS ISO 11990: 2002 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts ISO 11990:1999
AS EN 12182-2002 Technical aids for disabled persons - general requirements and test methods EN 12182:1999
AS ISO 14160-2002 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants ISO 14160:1998
AS/NZS ISO 15004: 2002 Ophthalmic instruments - Fundamental requirements and test methods ISO 15004:1997
AS EN 45502.1-2002 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer EN 45502-1:1997
AS ISO 13485-2002 Quality systems - Medical devices - Particular requirements for the application of ISO 9001 ISO 13485:1996
AS ISO 13488-2002 Quality systems - Medical devices - particular requirements for the application of ISO 9002 ISO 13488:1996
AS EN 46003-2002 Quality systems - Medical devices - Particular requirements for the application of ISO 9003 EN 46003:1999
AS EN 50103-2002 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry EN 50103:1995
AS IEC 60645.1-2002 Electroacoustics - Audiological equipment - Pure-tone audiometers IEC 60645-1:2001 (Modified)
AS IEC 60645.2-2002 Electroacoustics - Audiological equipment - Equipment for speech audiometry IEC 60645-2:1993
AS IEC 60645.3-2002 Electroacoustics - Audiological equipment - Auditory test signals of short duration for audiometric and neuro-otological purposes IEC 60645-3:1994
AS IEC 60645.4-2002 Electroacoustics - Audiological equipment - Equipment for extended high-frequency audiometry IEC 60645-4:1994

Top of page

Attachment 2: Documents adopted as Australian Standards - Round 2 - June 2003

Australian Standard Reference Title ISO/IEC/CEN/
CENELEC Equivalent
AS/NZS 3200.2.46:2003 Medical electrical equipment-Part 2.46: Particular requirements for the safety of operating tables IEC 60601-2-46:1998
AS 61010.1-2003 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1: General requirements IEC 61010-1:2001
AS 1600.2-2003 Medical equipment-Conical fittings with a 6 percent (Luer) taper for syringes, needles and certain other medical equipment-Part 2: Lock fittings ISO 594-2:1998
AS ISO 9360.1-2003 Anaesthetic and respiratory equipment-Heat and moisture exchangers (HMEs) for humidifying respired gases in humans-Part 1: HMEs for use with minimum tidal volumes of 250 ml ISO 9360-1:2000
AS ISO 9360.2-2003 Anaesthetic and respiratory equipment-Heat and moisture exchangers (HMEs) for humidifying respired gases in humans-Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml ISO 9360-2:2001
AS ISO 10993.4-2003 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2002
AS ISO 10993.7-2003 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals ISO 10993-7:1995
AS ISO 10993.8-2003 Biological evaluation of medical devices-Part 8: Selection and qualification of reference materials for biological tests ISO 10993-8:2000
AS ISO 10993.10-2003 Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity ISO 10993-10:2002
AS ISO 10993.14-2003 Biological evaluation of medical devices-Part 14: Identification and quantification of degradation products from ceramics ISO 10993-14:2001
AS ISO 10993.15-2003 Biological evaluation of medical devices-Part 15: Identification and quantification of degradation products from metals and alloys ISO 10993-15:2000
AS ISO 11134-2003 Sterilization of health care products-Requirements for validation and routine control-Industrial moist heat sterilization ISO 11134:1994
AS ISO 11979.1-2003 Ophthalmic implants-Intraocular lenses-Part 1: Vocabulary ISO 11979-1:1999
AS ISO 11979.2-2003 Ophthalmic implants-Intraocular lenses-Part 2: Optical properties and test methods ISO 11979-2:1999
AS ISO 11979.3-2003 ISO 11979-3:1999 Ophthalmic implants-Intraocular lenses-Part 3: Mechanical properties and test methods ISO 11979-3:1999
AS ISO 11979.4-2003 Ophthalmic implants-Intraocular lenses-Part 4: Labelling and information ISO 11979-4:2000
AS ISO 11979.5-2003 Ophthalmic implants-Intraocular lenses-Part 5: Biocompatibility ISO 11979-5:1999
AS ISO 11979.6-2003 Ophthalmic implants-Intraocular lenses-Part 6: Shelf-life and transport stability ISO 11979-6:2002
AS ISO 11979.7-2003 Ophthalmic implants-Intraocular lenses-Part 7: Clinical investigations ISO 11979-7:2001
AS ISO 11979.8-2003 Ophthalmic implants-Intraocular lenses-Part 8: Fundamental requirements ISO 11979-8:1999
AS ISO 16061-2003 Instrumentation for use in association with non-active surgical implants-General requirements ISO 16061-2000
AS EN 12442.1-2003 Animal tissues and their derivatives utilized in the manufacture of medical devices-Part 1: Analysis and management of risk EN 12442-1:2000
AS EN 12442.2-2003 Animal tissues and their derivatives utilized in the manufacture of medical devices-Part 2: Controls on sourcing, collection and handling EN 12442-2:2000
AS EN 12442.3-2003 Animal tissues and their derivatives utilized in the manufacture of medical devices-Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents EN 12442-3:2000
AS ISO 14534-2003 Ophthalmic optics-Contact lenses and contact lens care products-Fundamental requirements ISO 14534:2002
AS ISO 14602-2003 Non-active surgical implants-Implants for Osteosynthesis-Particular requirements ISO 14602:1998
AS ISO 14630-2003 Non-active surgical implants-General requirements ISO 14630:1997
AS ISO 14708.1-2003 Implants for surgery-Active implantable medical devices-Part 1: General requirements for safety, marking and for information to be provided by the manufacturer ISO 14708-1:2000
AS ISO 14949-2003 Implants for surgery-Two-part addition-cure silicone elastomers ISO 14949:2001
AS ISO 15225-2003 Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange ISO 15225:2000
AS ISO 15539-2003 Implants for surgery-Two-part addition-cure silicone elastomers ISO TS 15539:2000
AS ISO 25539.1-2003 Cardiovascular implants-Endovascular devices-Part 1: Endovascular prostheses ISO 25539-1:2003
AS ISO 5840-2003 Cardiovascular implants-Cardiac valve prostheses ISO 5840:1996
AS ISO 7198-2003 Cardiovascular implants-Tubular vascular prostheses ISO 7198:1998

Top of page