Regulation of non-prescription medicinal products : Department of Health and Ageing, Therapeutic Goods Administration / The Auditor-General

Creator
Australian National Audit Office
Call Number
Nq 328.94 AUS
Created/Published
Canberra : Australian National Audit Office, c2004
Images
162
View Catalogue

Contents

Regulation of Non-prescription Medicinal Products 1
Regulation of Non-prescription Medicinal Products 3
Contents 7
Abbreviations 9
Glossary 10
Summary and Recommendations Summary 13
Recommendations 23
Audit Findings and Conclusions 1. Introduction 31
2. Licensing and Certification of Manufacturers 42
3. Preparing and Executing the Audit Program 52
4. Conducting Manufacturer Audits 66
5. Addressing Manufacturer Non-compliance 78
6. Monitoring Compliance of Approved Products 94
7. Addressing Product Non-compliance 108
8. Management Framework 116
Appendices Appendix 1: Levels of therapeutic promise and therapeutic claims 125
Appendix 2: MRAs and MOUs/cooperative arrangements 128
Appendix 3: Classification of GMP compliance, 1992-2003 130
Appendix 4: Audit effort for non-prescription medicine manufacturers, 1999-2003 (hours) 131
Appendix 5: Classification of deficiencies, 1995-2003 132
Appendix 6: Key TGA steps in addressing manufacturer non-compliance 133
Appendix 7: Example of addressing a manufacturer’s non-compliance 134
Appendix 8: Triage criteria for Adverse Reaction Reports 136
Appendix 9: Adverse Reaction Reports referred to the CM EC, 2002-2003 137
Appendix 10: Reviews of non-prescription medicinal products and substances, 1999-2004 138
Appendix 11: Recall and cancellation options 140
Appendix 12: A large product recall 142
Appendix 13: Product cancellations in connection with a large manufacturer 144
Appendix 14: Fees and charges 145
Appendix 15: Departmental response 148
Index 156
Series Titles 158
Better Practice Guides 160

Text

Cite

Citation options:
Work identifier

http://nla.gov.au/nla.obj-1063613379

APA citation

Australian National Audit Office & Nicoll, Gillian. (2004). Regulation of non-prescription medicinal products : Department of Health and Ageing, Therapeutic Goods Administration Retrieved April 12, 2026, from http://nla.gov.au/nla.obj-1063613379

MLA citation

Australian National Audit Office and Nicoll, Gillian. Regulation of non-prescription medicinal products : Department of Health and Ageing, Therapeutic Goods Administration Canberra: Australian National Audit Office, 2004. Web. 12 April 2026 <http://nla.gov.au/nla.obj-1063613379>

Harvard/Australian citation

Australian National Audit Office & Nicoll, Gillian. 2004, Regulation of non-prescription medicinal products : Department of Health and Ageing, Therapeutic Goods Administration Australian National Audit Office, Canberra viewed 12 April 2026 http://nla.gov.au/nla.obj-1063613379

Wikipedia citation

{{Citation
  | author1=Australian National Audit Office.
  | author2=Nicoll, Gillian.
  | title=Regulation of non-prescription medicinal products : Department of Health and Ageing, Therapeutic Goods Administration
  | year=2004
  | section=159 pages : illustrations ; 25 cm.
  | isbn=0642808112
  | series=Parliamentary paper (Australia. Parliament) ;
  | issue=PP no. 6 of 2005, AR no. 18 (2004/2005)
  | location=Canberra
  | publisher=Australian National Audit Office
  | url=http://nla.gov.au/nla.obj-1063613379
  | id=nla.obj-1063613379
  | access-date=12 April 2026
  | via=Trove
}}

Citations are automatically generated and may require some modification to conform to exact standards.

Download

Select the images you want to download, or the whole document.

Available formats
TIF high resolution
Include
All
Current

Or select a range of images:

Order

You can order a copy of this work from Copies Direct.

Copies Direct supplies reproductions of collection material for a fee. This service is offered by the National Library of Australia

Include

Or select a range of images:

Share

Share on Twitter

Share on Facebook

What can I do with this?

In Copyright

Reason for copyright status
Unable to determine date of publication or creation

You may copy under some circumstances, for example you may copy a portion for research or study. Order a copy. Contact us for further information about copying.

Copyright status was determined using the following information:

Creator Status
Undetermined [Creator(s) Date Information is Incomplete]
Material type
Literary, dramatic or musical work
Published status
Unpublished

Copyright status may not be correct if data in the record is incomplete or inaccurate. Other access conditions may also apply.

For more information please see: Copyright in library collections.