Joint Expert Committee on Labelling Requirements for Medicines
Terms of reference
The Expert Committee will consider, and make recommendations on, a harmonised standard for the labelling of medicines (which meets the public health needs of the people of Australia and New Zealand) to be applied by the new joint therapeutic products agency.
In addition to developing a draft Trans Tasman Labelling Order for consultation and finalisation prior to 1 July 2006, the Expert Committee will provide advice, where requested by the TGA / Medsafe, on matters relating to medicine labelling.
The Expert Committee will as part of the process, review:
- the current legislative requirements for medicines labelling in Australia and New Zealand.
In its considerations, the committee will be mindful of:
- labelling issues / reviews currently under consideration by the Therapeutic Goods Administration and / or Medsafe;
- the desirability of consolidating all necessary changes as a consequence of the trans Tasman arrangements into a single action;
- the need for ready identification of products being recalled;
- the needs of consumers and health professionals; and
- compliance costs for industry.
The committee will report to Therapeutic Products Interim Ministerial Council and the TGC in addition to the TGA and Medsafe on the outcomes of its considerations.
Membership
| Name | Affiliation | Expertise |
|---|---|---|
|
Prof. David Story (AUS) |
Innovation Professor, and Professor Emeritus, RMIT University. Former Professor of Pharmacology and Dean, Faculty of Life Sciences, RMIT University. Member and Former President, Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. Former Head, Department of Pharmacology, University of Melbourne. Member, Medicines Evaluation Committee. |
Pharmacology. Therapeutic goods regulation. Senior academic management. |
|
Ms Jenny Bergin (AUS) |
Pharmacist Consultant, Pharmacy Guild of Australia. Board Member, National Prescribing Service Limited. Former Member of the Pharmacy Board of Tasmania. |
Practice of Pharmacy. Quality improvement approach to the management of health services and the quality use of medicines. |
|
Dr Mark Bowden (AUS) |
Director, Research and Development, Pfizer Consumer Healthcare. Member, Therapeutic Goods Committee, Committee of Management and the Regulatory & Technical Subcommittee of the Australian Self-Medication Industry Inc. Registered pharmacist. |
Manufacture of pharmaceuticals. Therapeutic Goods Regulation. |
|
A/Prof. Shane Carney (AUS) |
Associate Professor of Medicine, Faculty of Health, The University of Newcastle. Consultant Nephrologist at John Hunter Hospital. Secretary, Executive Committee, The Hunter Postgraduate Medical Institute. Member, Australian Pharmaceutical Advisory Council. Chairman, Therapeutics Advisory Committee of the Royal Australasian College of Physicians. Board of Directors, National Prescribing Service Limited. |
Physician. Postgraduate medicine education. Quality use of medicines. |
|
Ms Bridget Crooks (NZ) |
Regulatory Affairs Manager, Weleda New Zealand Ltd. New Zealand Member of the Technical and Standards Committee and the Trans Tasman Harmonisation Group of the Complementary Healthcare Council of Australia. |
Naturopathy. Regulatory Affairs. Manufacture of medicines. |
|
Mr Philip Daffy (AUS) |
Director, Research and Development, Blackmores Ltd. Former consultant to the complementary medicines industry, including the Complementary Healthcare Council of Australia. Member, Therapeutic Goods Committee, Expert Advisory Panel to the Complementary Medicines Evaluation Committee. Member, Former Expert Committee on Complementary Medicines in the Health System. |
Product development and manufacture of complementary medicines. Therapeutic Goods Regulation. |
|
Ms Jan Donovan (AUS) |
Board Member, National Prescribing Service Limited. Consumer representative on the Medicines Evaluation Committee. Member, Consumers' Health Forum of Australia. Member, Australian Pharmaceutical Advisory Council, representing Council on the Ageing / National Seniors. |
Consumer issues, particularly consumer-focussed labelling and Consumer Medicines Information. Wise use of medicines in seniors. |
|
Mr John Fraser (NZ) |
Practicing pharmacist. NZ Conference award and NZ Pharmacy award for labelling paper. Immediate past President of Southland Pharmacists Assn. Southland Member of the Rural Primary Sector Advisory Group with the DHB. Trust Member of both the Tuatapere Medical & Hospital Trusts. Consultant to industry on labelling issues. |
Practice of pharmacy. Labelling issues. |
|
Ms Natalie Gauld (NZ) |
Member of the Pharmaceutical Society of New Zealand. Member of the Medicines Classification Committee. Associate Member of the Self-Medication Industries Association of New Zealand. Vice President of the Auckland Branch of the Pharmaceutical Society. Pharmacy Member on the PHO Advisory Group for Counties Manukau DHB. Part-time Community Pharmacist. Director Pharma Projects Ltd. Member of the College of Pharmacists. Editor and main author of Guide to Health through the School Years for consumers. On Editorial Board for Family Doctor Website. |
OTC medicines (has taught or written teaching material for pharmacy students and pharmacy assistant students). Medical writing, particularly for consumers. Pharmaceutical marketing. |
|
Mr John Lumby (AUS) |
Chief Pharmacist, Director, Pharmaceutical Services Branch, New South Wales Health Department. Member, National Co-ordinating Committee on Therapeutic Goods. Member, Complementary Medicines Evaluation Committee Expert Advisory Panel. Chairman, New South Wales Poisons Advisory Committee. |
Scheduling and access controls for medicines. Therapeutic goods regulation. |
|
Prof. Stella O'Donnell (AUS) |
Registered pharmacist in Queensland and Great Britain. Fellow of the Pharmaceutical Society of Australia and of the Royal Pharmaceutical Society of Great Britain. Chair, Therapeutic Goods Committee. Past-President of PSA (Queensland Branch). Visiting Scientist, Institute for Glycomics, Griffith University. Emeritus Professor, The University of Queensland. Honorary Professor, School of Health Science, Griffith University Gold Coast campus. Accredited Consultant Pharmacist. |
Pharmacology. Quality use of medicines in pharmacy practice. Therapeutic goods regulation. |
|
Mr Andrew Orange (NZ) |
Registered pharmacist. Clinical Services Manager with Manawatu Independent Practice Association. Medication reviewer in the Manawatu/Horowhenua, former lecturer and education services facilitator at Massey University UCOL and University of Otago postgraduate clinical pharmacy. Executive Member of the New Zealand Healthcare Pharmacists Association. Fellow of the New Zealand College of Pharmacists. Past Councillor of the New Zealand Pharmaceutical Society. Editor of Notes on Injectable Drugs. |
IPA facilitator, hospital pharmacy, drug information, optimal use of medicines as a therapy option. |
|
Prof. Paddy Phillips (AUS) |
Head of Medicine at Flinders University in South Australia. Member, Australian Council for Safety and Quality in Health Care. Royal Australasian College of Physicians, representative on the Medical Advisory Council of the Australian Patient Safety Foundation. |
Physician. Evidence-based practice. Safety and quality in healthcare. |
|
Ms Andrea Shirtcliffe (NZ) |
Medication Management Consulting Pharmacist. Project Pharmacist on Pharmacy Mental Health Project. Consultant pharmacist. Contract writer for Pharmacy Today. Deputy Chair of Pharmacy Council. Ministerial appointee to NZ Medicines Classification Committee. |
Practice of pharmacy and education. Medicines classification and utilisation. |
|
Mr Roger Smart (NZ) |
Director, Regulatory Affairs, Douglas Pharmaceuticals Ltd, Auckland. Member, Pharmaceutical Society of New Zealand, Pharmaceutical Society of Fiji, New Zealand Self-Medication Industry Association Inc), Australian Society of Clinical and Experimental Toxicologists and Pharmacologists, Drug Information Association and Regulatory Affairs Sub-committee of Non-Prescription Medicines Association of New Zealand. |
Practice of pharmacy. Manufacture of pharmaceuticals. |
|
Ms Penny Thornton (AUS) |
Hospital Pharmacist. Pharmacy Services Manager, The Children's Hospital at Westmead. Federal Councillor, The Society of Hospital Pharmacists of Australia (SHPA). Member, SHPA Project Steering Group on High Risk Medication Alerts. Member, Medication Taskforce of the Safety & Quality Council of Australia. Member, Development Group and Chair, Hospital Working Group, MediConnect Project. Former Member, Medicines Coding Council of Australia. Australian representative, Institute for Safe Medication Practices, USA. Editor of Medication Safety Series, Journal of Pharmacy Practice & Research. |
Safety and quality in healthcare. |
|
Prof. Les Toop (NZ) |
Head of Department of Public Health and General Practice, Christchurch School of Medicine. Past Chair of the former National Preferred Medicines Centre (PreMeC). Past Member of the former Pharmacology and Therapeutics Advisory Committee (PTAC). Member of the Advisory Board for WONCA Asia Pacific Medical Journal. |
Referred service utilisation. GP education. Direct-to-Consumer advertising of medicines. Inhaled and respiratory medications and management. |

