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Tuesday, 8 February 2005
Page: 192


Senator Allison asked the Minister representing the Minister for Health and Ageing, upon notice, on 16 November 2004:

(1)   Can details be provided of each of the audits conducted by the Therapeutic Goods Administration (TGA) in Australia since April 2003 including the name of manufacturer audited, the date of audit, the cost charged by the TGA and any subsequent action including products recalled.

(2)   Which manufacturers voluntarily withdrew licenses within 3 months of a TGA audit.

(3) (a)   Which manufacturers were advised by the TGA to voluntarily withdraw licenses; and (b) what was the form of that advice.

(4)   Can the reports of those audits be provided; if not, why not.

(5)   How many auditors are currently employed by the TGA.

(6)   How many contract auditors are currently being used by the TGA.

(7)   How many audits have been conducted by contract auditors.

(8)   Is it the correct that contract auditors are required to sign confidentiality agreements with the TGA; if so, why.

(9)   Have any audits since April 2003 found that formulae had been changed by the manufacturer without approval.

(10)   What is the process by which a manufacturer can resume a license previously voluntarily withdrawn.

(11)   To the knowledge of the TGA, how many and which Australian manufacturers have or intend to transfer their production overseas.

(12)   Is it the correct that the TGA does not undertake unannounced audits of overseas manufacturing sites.

(13)   Can copies be provided of the audits conducted on the Sigma Company since 1997.

(14)   Has there been any change in the auditing standard since 1998; if so, what are the changes.

(15)   Were any of the following found in any of these audits; if so, what was found: (a) serious, widespread deficiencies in the company’s manufacturing and quality control procedures; (b) substitution and/or omission of active ingredients; and (c) falsification of documents; (d) systematic and deliberate manipulation of test results; (e) inadequate cleaning of equipment between manufacture of different products; and (f) failure of end product testing prior to release of the product for supply to consumers.


Senator Patterson (Minister for Family and Community Services and Minister Assisting the Prime Minister for Women’s Issues) —The Minister for Health and Ageing has provided the following answer to the honourable senator’s question:

(1)   A list of audits conducted by the TGA from 1 May 2003 to 16 November 2004 is at Attachment 1.         Australian medicinal product manufacturers are required to pay an annual licence charge of $4,230 if they undertake a single step in manufacture (eg sterilization only, packaging only) or $8,210 for multiple step manufacturing or for multiple products (such as medicines and medical devices). These charges allow for 16 audit hours in three financial years for the lower annual licence charge, and 48 audit hours for the higher charge. Where the audit hours exceed these times, the TGA charges for the additional audit time involved.         Following these audits, recalls were conducted on 38 products, of which one product was at consumer level, 10 products at retail level, 11 products at wholesale level, and 16 products at hospital level.

(2)   The following manufacturers requested suspension of their licences within three months of the TGA audit dates.

  • Excel Pharmaceuticals Pty Ltd                                             Suspension
  • Narwhal Pty Ltd trading as Ramprie Laboratories           Suspension
  • Soul Pattinson Manufacturing Pty Ltd                              Suspension

No manufacturer requested revocation of their licence within three months of the TGA audit date of their manufacturing site.

(3) (a)   &(b)- (4)

The TGA does not ordinarily advise manufacturers to voluntarily request suspension or revocation of a licence. However, if requested, the TGA would provide advice on all options available to the manufacturer regarding continuation of their licence.

(5)   The TGA audit team comprises 26 lead auditors and up to 34 specialists.

(6)   - (8) The TGA does not have contract auditors.

(9)   Generally at audit, the auditor will sample some of the formulations for compliance with details on the Australian Register of Therapeutic Goods. during the period specified, some manufacturers were found to have formulations that were not aligned with the details on the Register. Depending on the class of the product and the nature of the change, some amendments to formulation did not require TGA approval (eg excipients of complementary medicines). Any changes that required TGA approval were raised in the context of non-compliance with the marketing authorization.

(10)   If a licence has been suspended at the request of the manufacturer, the TGA will undertake an on-site audit, which must demonstrate compliance with the relevant Code of GMP before the suspension can be lifted. If the licence was revoked, a new application for a manufacturing licence is required.

(11)   Information on Australian manufacturers that may have transferred or intend to transfer their production overseas is not recorded on TGA information system. The TGA does not require manufacturers to divulge their reasons for seeking voluntary revocation of their licences.

(12)   Normally the TGA does not conduct unannounced audits of overseas manufacturers because it is necessary to obtain Australian sponsor’s agreement to the audit. Advance notice is given in as short a timeframe as practicable and no audit plan is provided in advance. Should the TGA have significant concerns relating to prior warning, it would then seek the assistance of the relevant government regulatory agency in conducting a joint unannounced audit with that overseas regulator.         The TGA’s practice is consistent with that of other regulators that inspect manufacturers in other countries.

(13)   Audit reports are considered commercial-in-confidence and are not made available without the agreement of the manufacturers involved. The TGA approached the company to seek its agreement to release the reports. The company has advised it does not wish to release copies of the reports.

(14)   The Manufacturing Principles under the Therapeutic Goods Act 1989 prescribe the standards that apply to the manufacturer of therapeutic goods.

        There have been changes to the auditing standards prescribed as Manufacturing Principles since 1998 and these are outlined below.

2000:

Adoption of the Australian Code of Good Manufacturing Practice - Human Blood and Tissues, August 2000. This was a revision of the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Blood and Blood Components and the Code of Good Manufacturing Practice for Therapeutic Goods - Human Tissues, 1995, to include fresh blood and blood components, requiring Technical Master Files for fresh blood components.

2002:

2002:

Adoption of the ICH (International Conference on Harmonisation) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients as a Manufacturing Principle for the audit and licensing of manufacturers of active pharmaceutical ingredients in Australia.

Adoption of the Australian Code of GMP for Medicinal Products, August 2002, as a Manufacturing Principle for the audit and licensing of manufacturers of medicinal products in Australia. This document, which is based on the Pharmaceutical Inspection Cooperation Scheme’s Good Manufacturing Practice Guide for Medicinal Products (PIC/S GMP Guide), replaced the Australian Code of GMP for Therapeutic Goods, August 1990.

Attachment 1

GMP Audits conducted by TGA from 1 May 2003 to 16 November 2004

Audit Date

Manufacturer Name

19-May-04

3M AUSTRALIA PTY LTD

3-Nov-03

3M PHARMACEUTICALS PTY. LIMITED

28-Aug-03

A C E PACKWELL PTY LTD

2-Jul-04

ABBOTT AUSTRALASIA PTY LTD

25-Sep-03

ACT BONE BANK

31-May-04

ACT BONE BANK

12-Jul-04

ACT BONE BANK

16-Oct-03

ADP PHARMACEUTICALS PTY LIMITED

28-May-03

AGEN BIOMEDICAL LIMITED                              

12-Jan-04

AGEN BIOMEDICAL LIMITED                              

15-Jun-04

AGEN BIOMEDICAL LIMITED                               

6-Sep-04

ALKALOIDS OF AUSTRALIA PTY. LIMITED                  

13-Jan-04

ALOE VERA INDUSTRIES PTY LTD

24-May-04

ALOE WELLNESS AUSTRALIA PTY LTD   

16-May-03

ALPHAPHARM PTY LTD                                   

5-Jul-04

ALPHAPHARM PTY LTD                                    

2-May-03

AMDEL LIMITED                                        

25-Aug-04

AMDEL LIMITED                                        

9-Sep-03

ANALYTICA LABORATORIES PTY LTD                       

25-Feb-04

ANALYTICA LABORATORIES PTY LTD                       

28-Sep-04

ANDRESEN FISHERIES PTY LTD                        

22-Sep-04

ANNEX HOLDINGS PTY LTD TRADING AS ANNEX MARKETING SERVICES    

5-Apr-04

ANSTO T/A ARI (ANSTO RADIOPHARMACEUTICALS AND INDUSTRIALS)

11-Oct-04

ANSTO T/A ARI (ANSTO RADIOPHARMACEUTICALS AND INDUSTRIALS)

4-Dec-03

APS MEDICAL SDN BHD

28-Aug-04

ARGUS BIOMEDICAL PTY LTD

3-Jun-03

ASTRAZENECA PTY LTD                                  

18-Jul-03

AUS SYSTEMS PTY. LIMITED        

23-Jul-03

AUSSIE TUCKER TECHNIK PTY LTD T/AS IJ CONTRACT PHARMACEUTICALS  

12-Dec-03

AUSSIE TUCKER TECHNIK PTY LTD T/AS IJ CONTRACT PHARMACEUTICALS  

14-Jul-04

AUSTRALERBA HERBAL PRODUCTS & SPAGYRIC LABORATORIES   

6-Sep-04

AUSTRALIAN ALKALOIDS PTY LTD

24-May-04

AUSTRALIAN ALOE PTY LTD

28-Jun-04

AUSTRALIAN BONE MARROW DONOR REGISTRY                 

20-Apr-04

AUSTRALIAN BOTANICAL PRODUCTS PTY. LTD.           

22-Sep-03

AUSTRALIAN ORTHOPAEDIC FIXATIONS PTY LTD             

1-Mar-04

AUSTRALIAN PHARMACEUTICAL MANUFACTURERS PTY LTD    

22-Aug-03

AUSTRALIAN PHARMACEUTICAL SERVICES PTY LTD       

31-May-04

AUSTRALIAN PHARMACEUTICAL SERVICES PTY LTD       

11-Nov-04

AUSTRALIAN PHARMACEUTICAL SERVICES PTY LTD       

12-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   ACT

24-Jul-03

AUSTRALIAN RED CROSS BLOOD SERVICE   NSW

4-Aug-03

AUSTRALIAN RED CROSS BLOOD SERVICE   NSW

5-Aug-03

AUSTRALIAN RED CROSS BLOOD SERVICE   NSW

6-Aug-03

AUSTRALIAN RED CROSS BLOOD SERVICE   NSW

5-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

18-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

27-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

4-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

5-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

29-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

17-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

31-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE   SA

2-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE   TAS

5-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE   TAS

26-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

27-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

27-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

27-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

27-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

28-Jul-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

29-Jul-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

31-Jul-03

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

7-Sep-04

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

8-Sep-04

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

9-Sep-04

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

10-Sep-04

AUSTRALIAN RED CROSS BLOOD SERVICE   WA

16-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE NORTH WEST REGION

17-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE NORTH WEST REGION

1-May-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

18-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

12-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

21-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

22-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

23-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

29-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

30-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

6-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

23-Feb-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

26-Feb-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

18-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

2-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

5-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

5-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

5-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

5-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

3-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

16-Jun-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

24-Jun-04

AUSTRALIAN RED CROSS BLOOD SERVICE NSW

18-Aug-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

20-Aug-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

15-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

29-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

1-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

9-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

16-Dec-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

17-Dec-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

18-Dec-03

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

5-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

6-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

23-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

23-Jun-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

23-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

26-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

4-Oct-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

11-Oct-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

12-Oct-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

13-Oct-04

AUSTRALIAN RED CROSS BLOOD SERVICE QLD

16-Jul-04

AUSTRALIAN RED CROSS BLOOD SERVICE TAS

2-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE TAS

5-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE TAS

16-Aug-04

AUSTRALIAN RED CROSS BLOOD SERVICE TAS

4-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

4-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

4-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

4-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

5-Jun-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

1-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

12-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

16-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

14-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

15-Oct-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

14-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

18-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

20-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

21-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

25-Nov-03

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

18-Feb-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

15-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

16-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

27-Apr-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

17-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

18-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

31-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

1-Jun-04

AUSTRALIAN RED CROSS BLOOD SERVICE VIC

15-Sep-03

AUSTRALIAN RED CROSS BLOOD SERVICE WA

1-Mar-04

AUSTRALIAN RED CROSS BLOOD SERVICE WA

17-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE WA

24-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE WA

27-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE WA

28-May-04

AUSTRALIAN RED CROSS BLOOD SERVICE WA

29-Apr-04

AUSTRALIAN SURGICAL DESIGN & MANUFACTURE PTY LTD

27-Nov-03

BALDWIN MEDICAL & VETERINARY DEVICES (AUSTRALIA) PTY LTD T/A BALDWIN MEDICAL

20-Apr-04

BAXTER HEALTHCARE PTY LTD                                

23-Apr-04

BAXTER HEALTHCARE PTY LTD                                

27-Apr-04

BAXTER HEALTHCARE PTY LTD                                

14-May-04

BAXTER HEALTHCARE PTY LTD                                 

11-May-04

BAYER AUSTRALIA LIMITED                             

28-Jun-04

BENRA PTY LTD TRADING AS GELFLEX LABORATORIES        

15-Dec-03

BETTER SACHETS PTY LTD

16-Mar-04

BIO NOVA INTERNATIONAL PTY LTD

12-Jul-04

BIOCLONE AUSTRALIA PTY LTD                          

17-Dec-03

BIOPHARM AUSTRALIA PTY LTD

16-Feb-04

BIOTECH PHARMACEUTICALS PTY LTD                      

13-Jul-04

BIOVITAL PTY LTD                                     

29-Jul-04

BLOOMS HEALTH PRODUCTS PTY LIMITED                   

27-Sep-04

BOOT HEALTHCARE AUSTRALIA PTY LTD

26-May-03

BRAUER NATURAL MEDICINE PTY. LTD.                      

27-Oct-03

BRESAGEN LIMITED    ACN 007 988 767

20-Sep-04

BRIEMAR NOMINEES PTY. LTD.                            

11-Dec-03

BRISBANE NORTH REGIONAL HEALTH AUTHORITY T/A ROYAL BRIS HOSP NUCLEAR MED

8-Jun-04

BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD

2-Sep-04

BRONSON & JACOBS PTY LTD                             

1-Jul-04

BRUCE GRAHAM TRADING AS BRUCE GRAHAM CONSULTING      

13-Nov-03

CARDINAL HEALTH AUSTRALIA 200 PTY LTD TRADING AS ALLEGIANCE   

25-Jun-03

CARDINAL HEALTH AUSTRALIA 401 PTY LTD TRADING AS R.P.SCHERER  

3-May-04

CARDIO DESIGN PTY LTD

7-Sep-04

CBIO LTD

17-Jun-03

CELLABS PTY LIMITED

20-Apr-04

CENTRAL SYDNEY AREA HEALTH SERVICE TRADING AS RACHEL FORSTER BONE BANK

27-Apr-04

CENTRE FOR BLOOD CELL THERAPIES

6-Nov-03

CENTRE FOR PHYTOCHEMISTRY & PHARMACOLOGY AT SCU       

26-Oct-04

CHEMICON AUSTRALIA PTY LTD                            

21-Sep-04

CHEMIKA PTY LIMITED                                  

8-Nov-04

CIBA VISION AUSTRALIA PTY LTD

14-May-03

CLVR PTY LTD

24-Sep-03

COCHLEAR LIMITED                                     

5-May-04

COLGATE-PALMOLIVE PTY LTD                            

21-Jul-03

COMAX-PHARMA PTY LTD                                  

14-Jul-04

COMAX-PHARMA PTY LTD                                 

11-Dec-03

CONSULCHEM PTY LTD

2-Mar-04

CONSULCHEM PTY LTD

11-Feb-04

CONTRACT MANUFACTURING & PACKAGING SERVICES PTY LTD  

16-Nov-04

CONTRACT PHARMACEUTICALS SERVICES OF AUSTRALIAlia

1-May-03

CORAL MOON INTERNATIONAL PTY. LTD.                   

27-May-03

COSMETIC MANUFACTURERS (AUST) PTY. LTD.              

23-Feb-04

CRYOSITE LIMITED          

29-Oct-03

CSL LIMITED                                         

5-May-03

CSL LIMITED                                          

12-May-03

CSL LIMITED                                          

8-Dec-03

CSL LIMITED                                          

28-Sep-04

CUMBERLAND INDUSTRIES LTD TRADING AS COMPLETE CLEAN-PAC SERVICES

30-Jun-03

CUSTOM LENSES AUSTRALIA PTY LTD                      

11-Mar-04

CYCLOTEK PTY LTD

7-Jun-04

DEFRIES INDUSTRIES PTY LTD

14-Sep-04

DELTA LABORATORIES

22-Apr-04

DEPARTMENT OF MICROBIOLOGY KING EDWARD & PRINCESS MARGARET HOSPITAL

9-Jun-04

DEPUY AUSTRALIA PTY LTD

2-Sep-03

DIAMED AUSTRALIA PTY. LIMITED                           

10-Nov-04

DIFA CHEMICAL INDUSTRIES PTY LTD

25-Nov-03

DRAEGER MEDICAL AUSTRALIA PTY LTD                         

8-Nov-04

DYNEK PTY LTD

4-Mar-04

E.L. BELL PACKAGING PTY LTD                          

23-Jun-03

EIFFEL TECHNOLOGIES LIMITED      

23-Feb-04

ELLEX MEDICAL PTY LTD

1-Aug-03

EML CONSULTING SERVICES QLD PTY LTD                              

1-Sep-04

ENSIGN LABORATORIES PROPRIETARY LIMITED               

9-Sep-04

EURELLA COMMUNITY SERVICES INC.    

28-Oct-03

EXCEL PHARMACEUTICALS PTY LTD                              

31-Aug-04

EXEL (AUSTRALIA) LOGISTICS PTY LTD                         

3-Nov-04

F.H. FAULDING & CO. LIMITED TRADING AS MAYNE PHARMA INTERNATIONAL

1-Apr-04

FAIRMONT MEDICAL PRODUCTS PTY. LIMITED              

19-Nov-03

FAULDING HEALTHCARE PTY LTD    

17-May-04

FAULDING HEALTHCARE PTY LTD    

8-May-03

FELTON GRIMWADE & BICKFORD PTY LTD

6-Jul-04

FINISHING SERVICES PTY. LTD.                           

24-Jul-03

FLINDERS MEDICAL CENTRE TRADING AS THE EYE BANK OF SOUTH AUSTRALIA

27-Sep-04

FRESENIUS MEDICAL CARE AUSTRALIA PTY LTD             

30-Mar-04

GAMBRO PTY LTD

1-Jul-04

GELFLEX PTY LTD

27-Aug-04

GENRX PTY LTD

28-Apr-04

GLAXOSMITHKLINE AUSTRALIA PTY LTD (CONSUMER HEALTHCARE DIVISION)

4-Feb-04

GLOBAL MANUFACTURING TECHNOLOGY PTY LTD            

18-Dec-03

GMP PHARMACEUTICALS PTY LIMITED                      

2-Nov-04

GMP PHARMACEUTICALS PTY LIMITED                      

8-Nov-04

GOLD COAST LABORATORIES PTY LTD

6-Sep-04

H C L MANUFACTURERS PTY. LTD.                        

30-May-03

HAIR ADVISORY CENTRE PTY LTD TRADING AS QUEENSLAND COSMETIC LABORATORIES

14-Oct-03

HAIR ADVISORY CENTRE PTY LTD TRADING AS QUEENSLAND COSMETIC LABORATORIES

28-Apr-04

HAIR ADVISORY CENTRE PTY LTD TRADING AS QUEENSLAND COSMETIC LABORATORIES

20-Oct-04

HAMILTON PHARMACEUTICALS

29-Jul-03

HANNA MATCH (AUSTRALIA) PTY LTD

9-Dec-03

HCoA OPERATIONS (AUSTRALIA) PTY LTD

3-Nov-03

HEALTH WORLD LIMITED                                  

11-Oct-04

HEALTH WORLD LIMITED                                 

15-May-03

HEALTHVISION PTY LTD T/A MEDICATION PACKAGING SYSTEMS        

5-Dec-03

HEALTHVISION PTY LTD T/A MEDICATION PACKAGING SYSTEMS        

8-Nov-04

HEALTHVISION PTY LTD T/A MEDICATION PACKAGING SYSTEMS        

28-May-03

HERBAL SUPPLIES PTY LTD

6-Oct-04

HERBPHARM AUSTRALIA PTY LTD

1-Jul-04

HERBWORX CORPORATION PTY LTD

29-Jul-03

HERRON PHARMACEUTICALS PTY LTD                    

13-Oct-03

HERRON PHARMACEUTICALS PTY LTD                    

12-Nov-03

HOLISTIC PRODUCTS GROUP PTY LTD    

16-Jun-03

HOMART PHARMACEUTICALS PTY LTD   

27-Oct-04

HOMART PHARMACEUTICALS PTY LTD   

11-Dec-03

HOUSE WITH NO STEPS, HUNTER VALLEY REGION           

8-Dec-03

HUNTER AREA PATHOLOGY SERVICE

5-Aug-04

HYDRATION PHARMACEUTICALS PTY LTD

10-Nov-04

HYDRON PTY LIMITED                                    

30-Jun-04

HYDRON PTY LTD T/AS COOPERVISION SURGICAL                

21-Jan-04

IMTHAGE PTY LTD

9-Mar-04

INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LIMITED       

30-Aug-04

INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LIMITED       

21-Jul-03

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

23-Jul-03

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

25-Jul-03

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

16-Dec-03

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

18-Dec-03

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

1-Apr-04

INSTITUTE OF MEDICAL & VETERINARY SCIENCE

21-Apr-04

ISOLAGEN TECHNOLOGIES PTY LTD

6-May-03

JALCO AUSTRALIA PTY. LIMITED                          

25-Oct-04

JALCO AUSTRALIA PTY. LIMITED                         

25-Sep-03

JALCO COSMETICS PTY. LIMITED    

23-Feb-04

JALCO COSMETICS PTY. LIMITED    

24-Aug-04

JOHNSON & JOHNSON MEDICAL PTY LTD                    

11-Aug-04

JOHNSON & JOHNSON PACIFIC PTY LTD                    

2-Aug-04

KARRI INDUSTRIES PTY LTD

30-Sep-04

KEV MEDICAL PTY.LTD.                            

21-Oct-04

KEY PHARMACEUTICALS PTY LTD

10-Sep-04

KIMBERLY CLARK AUST PTY LTD

23-Apr-04

KING EDWARD & PRINCESS MARGARET HOSPITAL - DEPT OF MICROBIOLOGY

19-Apr-04

KING EDWARD & PRINCESS MARGARET HOSPITAL T/A   - AUSPMAN

15-Dec-03

LABMARK PTY LIMITED      

26-Sep-03

LIONS NSW EYE BANK

11-Jun-03

LIPA PHARMACEUTICALS LTD      

21-Jul-03

LIPA PHARMACEUTICALS LTD     

20-Jan-04

LIPA PHARMACEUTICALS LTD      

17-May-04

LIR AUSTRALIA PTY LTD   

20-May-04

LOGIKAL HEALTH PRODUCTS PTY LTD                      

13-Oct-04

LUCAS PAPAW REMEDIES

28-Jan-04

LUDWIG INSTITUTE FOR CANCER RESEARCH                 

29-Jun-04

LYNDELEN PTY LTD TRADING AS THE HERBAL EXTRACT COMPANY OF AUSTRALIA  

3-Jun-04

MACRO LABORATORIES PTY LTD                      

11-Aug-04

MANSELL NEONATAL TRANSPORT EQUIPMENT PTY LTD

8-Jul-03

MATCHLAND PTY. LTD. TRADING AS NEW PRODUCTS DEVELOPMENT (QLD)

2-Oct-03

MATCHLAND PTY. LTD. TRADING AS NEW PRODUCTS DEVELOPMENT (QLD)

19-Feb-04

MATCHLAND PTY. LTD. TRADING AS NEW PRODUCTS DEVELOPMENT (QLD)

16-Dec-03

MATER HEALTH SERVICES - PATHOLOGY

4-Dec-03

MATER MISERICORDIAE HEALTH SERVICES BRISBANE LIMITED T/A QUEENSLAND CORD

23-Sep-03

MAYNE HEALTH PATHOLOGY PTY LTD T/A MAYNE HEALTH LAVERTY PATHOLOGY

21-Apr-04

MAYNE HEALTH PATHOLOGY PTY LTD T/A MAYNE HEALTH LAVERTY PATHOLOGY

3-Aug-04

MCKINNON DIRECT PACKAGING & FULFILMENT PTY LTD

2-Feb-04

MEDICAL ACCESS PTY LTD T/AS CUSTOM MEDICAL PRODUCTS   

27-Sep-04

MEDIHERB PTY. LTD.                                    

17-Aug-04

MEDIHONEY PTY LTD

4-Dec-03

MEDI-REDI PTY. LTD.                                

3-Dec-03

MEGA PRODUCTS AUSTRALIA PTY LTD

25-Jun-03

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD                 

25-Nov-03

MERCY TISSUE ENGINEERING LTD                     

10-Feb-04

MILPHARMA PTY LTD                                    

28-Jan-04

MONASH UNIVERSITY TISSUE CULTURE LABORATORY

17-Jun-03

NARWHAL PTY LTD TRADING AS RAMPRIE LABORATORIES

6-Nov-03

NARWHAL PTY LTD TRADING AS RAMPRIE LABORATORIES

10-Sep-03

NATIONAL SEROLOGY REFERENCE LABORATORY, AUSTRALIA

16-Dec-03

NATURE'S CARE MANUFACTURE PTY. LIMITED TRADING AS LEIMEI NATURE'S CARE

29-Sep-04

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28-Oct-04

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20-May-04

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2-May-03

NIEBALL TRADING AS ADDMIX PTY LTD

26-Feb-04

NORSLED PTY LTD

11-Dec-03

NOVOGEN LABORATORIES PTY LTD                                  

28-Jun-04

NOWRA CHEMICAL MANUFACTURERS PTY LTD

14-Aug-03

NSI DENTAL PTY LTD

23-Aug-04

NUMICO RESEARCH AUSTRALIA PTY. LTD.                    

16-Jul-04

NUTRI HEALTH FOODS CENTRE PTY LTD

8-Aug-03

NUTRITION CARE PHARMACEUTICALS PTY LTD              

19-Nov-03

NUTRITION CARE PHARMACEUTICALS PTY LTD               

9-Sep-04

OLIVE LEAF AUSTRALIA PTY. LTD.                       

18-Aug-04

OPHTHALMIC LABORATORIES PTY LIMITED TRADING AS PHARMALAB      

4-Aug-04

ORIELTON LABORATORIES PTY LIMITED

20-Jan-04

ORIELTON LABORATORIES PTY LIMITED                       

19-Jun-03

ORION LABORATORIES PTY. LTD.                         

3-Nov-03

ORION LABORATORIES PTY. LTD.                           

6-Jan-04

ORION LABORATORIES PTY. LTD.                            

13-Sep-04

ORTHOMOLECULAR MEDISEARCH LABORATORIES PTY LTD TRADING AS BIOLOGICAL THERAPIES

30-Oct-04

OSMOFLOW PTY LTD

29-Oct-04

PACKCENTRE MARKETING SERVICES PTY. LTD.              

4-May-04

PAKCARE PTY. LIMITED                                  

22-Jul-03

Pan Pharmaceuticals  

27-Aug-03

Pan Pharmaceuticals  

29-Sep-03

Pan Pharmaceuticals  

30-Jul-03

PAX AUSTRALIA PTY LIMITED                           

14-Sep-04

PERTH BONE AND TISSUE BANK INCORPORATED

17-May-04

PFIZER   AUSTRALIA   PTY LIMITED  

29-Sep-04

PFIZER   AUSTRALIA   PTY LIMITED  

19-Apr-04

PFIZER (PERTH) PTY. LIMITED                     

9-Feb-04

PHARM-A-CARE LABORATORIES PTY. LIMITED                       

8-May-03

PHARMACTION MANUFACTURING PTY LIMITED                      

30-Sep-04

PHARMACTION MANUFACTURING PTY LIMITED                      

7-Oct-04

PHARMACTION MANUFACTURING PTY LIMITED                      

4-May-04

PHARMAPAK TECHNOLOGIES PTY LTD                     

26-Aug-03

PHARMATEL P/L

20-Aug-03

PLASVACC PTY LTD          

11-Nov-03

PORTLAND ORTHOPAEDICS LIMITED

20-Oct-04

PORTLAND SURGICAL PRODUCTS PTY LTD

14-Jul-04

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17-Jun-04

PRINCESS ALEXANDRA HOSPITAL (TRADING AS QUEENSLAND BONE BANK)

8-Oct-04

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18-Oct-04

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1-Mar-04

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16-Jun-04

PROGEN INDUSTRIES LIMITED

20-Aug-03

PROQUALIX PTY LTD   (formerly MERISANT MANUFACTURING AUSTRALIA PTY LTD)  

20-Sep-04

PROTHERICS AUSTRALASIA PTY LTD                       

3-Mar-04

PROUDEX AUSTRALIA PTY LTD   

23-Aug-04

QLD HEALTH SCIENTIFIC SERVICES

7-May-04

QUEENSLAND HEALTH PATHOLOGY SERVICE   DEPT OF MICROBIOLOGY

15-May-03

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2-Dec-03

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13-May-04

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6-Oct-04

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8-Sep-04

RAINBOW AND NATURE PTY LTD

10-Aug-04

RESMED PTY LTD

10-Jun-03

ROLAND INFECTION CONTROL PTY LTD                   

28-Sep-04

SANDOZ PTY LTD

1-Jul-03

SARSTEDT AUSTRALIA PTY LTD                           

15-Apr-04

SCENTAL PACIFIC PTY. LTD.                                 

28-Oct-03

SCHERING-PLOUGH PTY. LIMITED                         

5-Apr-04

SELBORNE BIOLOGICAL SERVICES (AUSTRALIA) PTY LTD      

5-Aug-04

SELECT LIFESTYLE PTY LTD

19-Jan-04

SENTRY MEDICAL PTY LTD

7-Sep-04

SIGMA PHARMACEUTICALS PTY LTD                       

8-May-03

SIGMA PHARMACEUTICALS PTY LTD                        

30-Jun-03

SIGMA PHARMACEUTICALS PTY LTD                        

19-Aug-03

SIGMA PHARMACEUTICALS PTY LTD                        

27-Aug-03

SILLIKER MICROTECH PTY. LTD.                   

30-Jun-04

SOFT COLOURS PTY LTD (FORMERLY GELFLEX)

28-Jul-03

SOUL PATTINSON (MANUFACTURING) PTY LTD               

2-Sep-03

SOUL PATTINSON (MANUFACTURING) PTY LTD              

14-Oct-03

SOUL PATTINSON (MANUFACTURING) PTY LTD             

2-Aug-04

SOUL PATTINSON (MANUFACTURING) PTY LTD               

19-Apr-04

SOUTH EASTERN AREA LABORATORY SERVICES, DEPT OF MICROBIOLOGY

6-Nov-03

SOUTH PACK LABORATORIES PTY. LTD.                    

18-Oct-04

SOUTH PACK LABORATORIES PTY. LTD.                    

10-Mar-04

ST VINCENT'S HOSPITAL (MELBOURNE) LIMITED TRADING AS   ST VINCENT'S PATHOLOGY

5-Nov-03

ST VINCENT'S HOSPITAL SYDNEY LIMITED TRADING AS SYDPATH

19-Jun-03

ST VINCENT'S HOSPITAL TRADING AS SYDNEY HEART VALVE BANK

14-Oct-03

STERITECH PTY. LTD.                                

2-Dec-03

STERITECH PTY. LTD.                                 

18-Oct-04

STERITECH PTY. LTD.                                 

4-May-04

SULLIVAN NICOLAIDES PTY LTD TRADING AS SULLIVAN NICOLAIDES PATHOLOGY

8-Sep-04

SUNDAY AUSTRALIA PTY LTD        

13-Jul-04

SWISSE VITAMINS PTY LTD

20-May-03

SYDNEY ADVENTIST HOSPITAL LTD                              

25-Sep-03

SYDNEY ADVENTIST HOSPITAL LTD                              

10-Dec-03

SYDNEY ADVENTIST HOSPITAL LTD                           

29-Aug-03

SYNCOR AUSTRALIA PTY LIMITED                      

29-Jul-03

SYNCOR AUSTRALIA PTY LIMITED TRADING AS RADPHARM SCIENTIFIC   

9-Sep-03

TABCO PTY LTD                                               

24-Feb-04

TABCO PTY LTD                                              

27-Sep-04

TABCO PTY LTD                                              

5-Sep-03

THE DOUGLAS HOCKING RESEARCH INSTITUTE - BONE BANK

27-Oct-03

THE ST GEORGE HOSPITAL TRADING AS NEW SOUTH WALES BONE BANK

30-Jan-04

THE UNIVERSITY OF MELBOURNE TRADING AS LIONS CORNEAL DONATION SERVICE

8-Jul-03

THERMO TRACE LTD   T/AS   THERMO ELECTRON CORPORATION     

23-Aug-04

THURSDAY PLANTATION LABORATORIES LTD                 

25-Aug-04

THURSDAY PLANTATION LABORATORIES LTD                 

24-Nov-03

TISSUE SCIENCE LABORATORIES PTY LTD

27-May-04

TRIPAK INDUSTRIES PTY LTD

1-Jul-03

ULTRA MIX (AUST.) PTY. LTD.                          

19-Aug-04

ULTRAVISION INTERNATIONAL (AUST) PTY LTD                      

27-Sep-04

UNOMEDICAL PTY LIMITED          

16-Oct-04

USCOM LTD

18-Aug-03

VERIGEN AUSTRALIA PTY LTD                                   

8-Jun-04

VERIGEN AUSTRALIA PTY LTD                                    

16-Aug-04

VITEX PHARMACEUTICALS PTY LTD

4-Aug-04

WHITELEY INDUSTRIES PTY LTD

12-Nov-03

WHOLISTIC TRADERS PTY LTD T/A ESSENCE AROMAPATHY

8-Dec-03

WILLIAM A. COOK AUSTRALIA PTY. LTD.                 

5-May-04

WOHLK-CONTACT LENSES AUSTRALIA PTY. LTD.