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TGC meeting 22, 11 August 2003
Therapeutic Goods Committee
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.
- The Therapeutic Goods Committee establishes a Subcommittee on Blood and Tissues.
- 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,
- The Subcommittee is to be Chaired by Associate Professor Rawlinson and have an appropriate membership drawn from experts in this field.
- The Therapeutic Goods Committee establishes a Subcommittee on Child-Resistant Packaging.
- 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.
- The Subcommittee is to be Chaired by Associate Professor Holley and have an appropriate expert membership.
- 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.
- 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:
- any labelling requirements specified in the Mandatory Advisory Statements for Medicine Labels;
- any warning statements specified in the standard that applies to the goods;
- a warning statement where incorrect route or method of administration may be hazardous;
- 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:
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:
- choose an appropriate medicine on their own;
- use the medicine safely and effectively;
- readily find the information they need, understand it and act on it; and
- access further information, if they want to know more about the medicine.
The mandatory aspects of this Order for all medicines are contained in clauses 1- 7 inclusive and the Schedules to the Order.
- Amend the definition of 'warning statements' contained in clause 2(1) Interpretation of Therapeutic Goods Order No. 69, to read
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
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
- 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.
- 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
- The Subcommittee is to be Chaired by Professor O'Donnell and have an appropriate expert membership, supplemented with relevant industry representation.
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.
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.
The Therapeutic Goods Committee notes:
- The Medical Device Standards Orders4 and Conformity Assessment Standards Orders5 gazetted to date; and
- Those EN, ISO and IEC standards on medical devices adopted as Australian Standards6 by Standards Australia.
|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|
|Australian Standard Reference||Title||ISO/IEC/CEN/
|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|