apvma gazette no. 15, 28 july 2015 · summary of use for the protection of buildings and other...

No. APVMA 15, Tuesday, 28 July 2015

Published by The Australian Pesticides and Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995.

The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products and

other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and

related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes

in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 15, Tuesday, 28 July 2015 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2015

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any

process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

The Manager, Public Affairs and Communications

The Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au.

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals grant ed by the APVMA, notices as required

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activ ity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

The APVMA Gazette is published in electronic format only and is available from the APVMA website,

www.apvma.gov.au/publications/gazette/.

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870

For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

mailto:[email protected]

http://www.apvma.gov.au/

http://www.apvma.gov.au/publications/gazette/


CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 10 Approved Active Constituents ....................................................................................................................................... 11 Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations ............................... 12 Reconsideration of Active Constituents, Registrations and Label Approvals related to Fenamiphos ............................ 13 Licensing of Veterinary Chemical Manufacturers .......................................................................................................... 18 Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 ........................................................................................................................................................................ 29


Agricultural Chemical Products and Approved Labels


Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of

the registration in respect of the following products and has approved the label or varied the relevant particulars or

conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. RESTRICTED PRODUCT

Application no.: 101648

Product name: HomeGuard Protectacote Termite And Waterproof Barrier

Active constituent/s: 0.65 g/L bifenthrin

Applicant name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of use For the protection of buildings and other structures from concealed entry by termites

Date of registration/approval: 9 July 2015

Product registration no.: 80789

Label approval no.: 80789/101648


Product name: AC Bithrin Termiticide & Insecticide

Active constituent/s: 100 g/L bifenthrin

Applicant name: Axichem Pty Ltd


Summary of use For the protection of structures from subterranean termite damage and for the control of termites and a range of other urban pests




2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Baracuda Liquid Chlorine

Active constituent/s: 130 g/L available chlorine (Cl) present as sodium hypochlorite

Applicant name: Zodiac Group Australia Pty Ltd


Summary of use For the control of bacteria and algae in swimming pools and spas





Product name: Titan Bensulfuron 600WG Herbicide

Active constituent/s: 600 g/kg bensulfuron-methyl

Applicant name: Titan Ag Pty Ltd


Summary of use For control of arrowhead, dirty dora and star fruit and suppression of cumbungi and common spike rush in aerially sown rice







Product name: Termidor Foam Termiticide & Insecticide

Active constituent/s: 0.05 g/kg fipronil

Applicant name: BASF Australia Ltd


Summary of use: For the control of subterranean termites, drywood termites and ants





Product name: AC Hexagon 50 SC Fungicide

Active constituent/s: 50 g/L hexaconazole



Summary of use For the control of powdery mildew and other fungi





Product name: AC Gunfire Herbicide

Active constituent/s: 275 g/L terbutryn, 160g/L MCPA present as the potassium salt



Summary of use: For the control of seedling broadleaf weeds in a variety of crops





Product name: AC Metrizoom 480 SC Herbicide

Active constituent/s: 480 g/L metribuzin

Applicant name: Axichem PTY LTD


Summary of use: For control in selective weeds in asparagus, barley, chickpeas,

faba beans, lentils, lupins, oats, pigeon peas, potatoes, soybeans,

tomatoes, wheat and vetch





Product name: AC Militate Herbicide

Active constituent/s: 800 g/L MSMA

Applicant name: Axichem PTY LTD


Summary of use: For use in the control of annual and perennial grasses and burrs in cotton, annual and perennial grasses in sugarcane, grass weeds in couch turf, prickly pear and grasses and burrs in non-crop areas







Product name: AC Promide 500 SC Herbicide

Active constituent/s: 500 g/L propyzamide



Summary of use: For certain grasses and broadleaf weeds in lettuce, turf, lawn, legume seed crops and pastures





Product name: AC Amon Herbicide

Active constituent/s: 250 g/L amitrol



Summary of use: For the control of weeds in orchards, vineyards, irrigation ditches and drains, roadsides, wheat and barley, and for general industrial situations





Product name: Eureka! Glyphosate 360 SL Herbicide

Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt

Applicant name: Eureka! Agresearch Pty Ltd


Summary of use: For non-selective control of many annual and perennial weeds and grasses in certain situations





Product name: Rotam Escudo 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Rotam Agrochemical CO., Ltd

Applicant ACN: N/A

Summary of use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies





Product name: Coles Multi Insect Killer

Active constituent/s: 0.9 g/kg d-allethrin 20:80, 0.9 g/kg d-phenothrin, 4.05 g/kg tetramethrin 20:80

Applicant name: Aaron Laboratories Proprietary Limited


Summary of use: For control of various flying and crawling insect pests in household situations







Product name: Baracuda Granular Chlorine

Active constituent/s: 700 g/kg available chlorine (Cl) present as calcium hypochlorite



Summary of use: For controlling bacteria, viruses & algae in swimming pools





Product name: Baracuda Multi Action Chlorine Tablets

Active constituent/s: 810 g/kg available chlorine present as trichloroisocyanuric acid, 7.5.g/kg copper present as copper sulphate pentahydrate



Summary of use: For the control of bacteria, viruses and algae in swimming pools





Product name: Baracuda Spa Lithium Chorine

Active constituent/s: 350 g/kg available chlorine (Cl) present as lithium hypochlorite



Summary of use: For the control of bacteria, viruses and algae in spas




3. VARIATIONS OF REGISTRATION

Application no: 102554

Product name: Richgro Caterpillar Grasshopper & Millipede Insecticide

Active constituent/s: 100 g/L carbaryl (an anticholinesterase compound)

Applicant name: A. Richards Pty Ltd T/A Richgro Garden Products


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘RICHGRO CARBARYL CATERPILLAR, GRASSHOPPER AND MILLIPEDE INSECTICIDE’ to ‘RICHGRO CATERPILLAR GRASSHOPPER & MILLIPEDE INSECTICIDE’

Date of variation: 11 May 2015






Product name: Autograph Fungicide

Active constituent/s: 800 g/kg fosetyl present as the aluminium salt

Applicant name: Turf Culture Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘TURF CULTURE AUTOGRAPH FUNGCIDE’ to ‘AUTOGRAPH FUNGICIDE’ and to update sites of manufacture

Date of variation: 29 June 2015




Product name: Wetter Pro Surfactant And Penetrant

Active constituent/s: 1020 g/L polyether modified polysiloxane

Applicant name: Amgrow Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘AMGROW ORGANOSILICONE SURFACTANT’ to ‘WETTER PRO SURFACTANT AND PENETRANT’

Date of variation: 7 July 2015




Product name: Arysta Lifescience Basilica 300 Herbicide

Active constituent/s: 300 g/L 2,4-D present as the isopropylamine salt

Applicant name: Chemtura Australia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘CHEMTURA BASILICA 300 HERBICIDE’ to ‘ARYSTA LIFESCIENCE BASILICA 300 HERBICIDE’





Product name: FMC Paraquat 350 SL Herbicide

Active constituent/s: 350 g/L paraquat present as paraquat dichloride

Applicant name: Cheminova Australia Pty Limited


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘CHEMINOVA PARAQUAT 350 SL HERBICIDE’ to ‘FMC PARAQUAT 350 SL HERBICIDE’







Product name: Pool Sanitiser & Oxidiser Bioguard Cal Chlor Clc 700

Active constituent/s: 700 g/kg chlorine present as calcium hypochlorite

Applicant name: Biolab Australia Pty Ltd


Summary of variation: To change the product name from ‘BIOGUARD CAL-CHLOR CLC 700 POOL SANITISER’ to ‘POOL SANITISER & OXIDISER BIOGUARD CAL CHLOR CLC 700’ and to update the pack size to a range of 500 g-40 kg




4. VARIATION OF LABEL APPROVAL


Product name: Nufarm Bouncer 960S Herbicide

Active constituent/s: 960 g/L s-metolachlor

Applicant name: Nufarm Australia Limited


Summary of variation: To update the application in cotton




Product name: Roundup Ultra Max Herbicide

Active constituent/s: 570 g/L glyphosate present as the potassium salt

Applicant name: Monsanto Australia Ltd


Summary of variation: To increase the rate of the pre-harvest wheat use pattern




Veterinary Chemical Products and Approved Labels

Veterinary Chemical Products and Approved Labels


Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of

the registration in respect of the following products and has approved the label or varied the relevant particulars or

conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Uniferon 200 Iron Dextran Injection

Active constituent/s: 200 mg/mL iron present as iron dextran complex

Applicant name: Pharmacosmos A/S

Applicant ACN: N/A

Summary of use For the prevention and treatment of iron deficiency anaemia in piglets

Date of registration/approval:

30 June 2015




Product name: Nutrictc 200 g Feed Additive Premix

Active constituent/s: 200 g/kg chlortetracycline hydrochloride

Applicant name: Nutriment Health Pty Ltd


Summary of use: For the treatment and prevention of diseases of pigs, poultry and calves, caused by bacteria sensitive to chlortetracycline

Date of registration/approval:

8 July 2015




Approved Active Constituents

Approved Active Constituents


Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of

the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSITUTENT


Active constituent/s: Cyhalofop-butyl

Applicant name: Dow Agrosciences Australia Limited


Summary of use: For use in agricultural chemical products

Date of approval: 8 July 2015

Approval no.: 80420


Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations

Inclusion of Active Constituent Approvals and Product Registrations in current Reconsiderations

The APVMA, in accordance with subsection 31(1) of the Agricultural and Veterinary Chemicals Code scheduled to the

Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), has initiated a reconsideration of the active

constituent approvals and product registrations listed in Attachment 1.

The basis for initiating these reconsiderations is concerns, as set out in Attachment 1, about whether or not the active

constituents and products continue to meet the safety criteria.

The active constituents and products in Attachment 1 were approved or registered after the commencement of the

corresponding chemical reviews listed in Attachment 2. These active constituents and products had not been placed

under formal reconsideration previously. Instead, these approvals and registrations were granted with a condition

providing that they would be subject to the outcomes of the corresponding chemical review.

From 1 July 2015, new legislative requirements became applicable to all reconsiderations. These requirements include

the preparation of a work plan for each reconsideration and that each reconsideration must be completed within the

timeframe prescribed by the regulations.

The APVMA has published the work plans along with the prescribed timeframes on its website for all the

reconsiderations currently in progress. This provides improved transparency around the chemical review process and the

facilitation of certainty around the timing of review decisions.

In order to apply all the legislative requirements uniformly to all the approvals and registrations when the corresponding

chemical is under review, from 1 July 2015, the APVMA will cease the practice of placing a condition at the time of

granting the approval or registration, providing that they would be subject to the outcomes of the corresponding chemical

review. Instead, it will reconsider the new approvals and registrations under subsection 31(1) of the Agvet Code.

Further details about the APVMA chemical review program or details of individual chemical reviews can be obtained from

the APVMA website www.apvma.gov.auor by request to the Chemical Review Liaison Officer on +61 2 6210 4700 or

[email protected].

APVMA CONTACT

Liaison Officer

Chemical Review

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4700

Fax: +61 2 6210 4776



[email protected]



Reconsideration of Active Constituents, Registrations and Label Approvals related to Fenamiphos


The APVMA, in accordance with Part 2, Division 4, of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet

Code), has reconsidered all approvals of the active constituent fenamiphos, registrations of all products containing

fenamiphos, and the approvals of all associated product labels. This notice is published in accordance with

paragraphs 34AC(1)(b) and 45A(1)(b) of the Agvet Code.

Fenamiphos is an organophosphorus nematicide and insecticide widely used in agriculture to control soil-borne pests

and sucking insects.

The active constituent fenamiphos, all products containing fenamiphos and their associated labels were placed under

review in 2003 because of concerns over its toxicity, occupational health and safety (OHS), residues in food (including

dietary exposure) environmental and trade aspects.

A preliminary review findings report was released for public comment in February 2013. The report identified that some

uses of fenamiphos products may pose an undue risk to the environment and public health. The proposed outcome was

that all products would be cancelled as no use could be supported on all grounds (toxicology, OHS, residues,

environment and trade aspects).

After consideration of all data including the advice received by the advising agencies (the Office of Chemical Safety in

the Department of Health and the Chemical Assessment Section in the Department of the Environment) and

consideration of submissions from industry and the public, the APVMA has now completed the reconsideration of the

active constituent approvals of fenamiphos, registrations of all products containing fenamiphos and the approvals of all

associated product labels.

Following the finalisation of its reconsideration of fenamiphos, the APVMA is satisfied that active constituent approvals

for fenamiphos listed in Table 1 meet the safety criteria. As a result, the APVMA has affirmed the active constituent

approvals for fenamiphos in accordance with subsection 34(1) of the Agvet Code.

The APVMA could not be satisfied that the chemical products listed in Tables 2 and 3 met the safety criteria and trade

criteria and therefore the APVMA could not affirm those products. However, under subsection 34A(1) of the Agvet Code,

the APVMA was satisfied that the relevant particulars of label approvals for the labels listed in Table 2 could be varied in

such a way as to allow the registration of products listed in Column B of Table 2 to be affirmed. As a result, the APVMA

has varied the relevant particulars for the label approvals for the products listed in Column B of Table 2 in accordance

with the outcomes contained in the Fenamiphos Review Findings Report and Regulatory Decision (July 2015). The

APVMA has consequently affirmed the registration of those products when used in accordance with the new label

approval numbers listed in Column D of Table 2 under subsection 34(1) of the Agvet Code. The APVMA is also satisfied

that the label approvals, listed in Column D of Table 2, meet the labelling criteria for the purposes of subsection 34(1)(c)

of the Agvet Code.

CANCELLATION OF PRODUCT REGISTRATION AND LABELS

As an outcome of the review, the registration of one product containing fenamiphos, and its associated label approvals

listed in Table 3, have been cancelled. Implementing the review findings in order for this particular product to meet the

safety criteria, trade criteria and efficacy criteria resulted in the approved label containing no remaining uses. As a

consequence, the APVMA cannot vary the product labels in such a way as to allow the registration to be affirmed. The

APVMA has therefore cancelled the product registration and associated label approvals under subsection 34AA(1) of the

Agvet Code.



The APVMA has also cancelled the approvals of all previously approved product labels (for label approval numbers listed

in Table 2, column D) from 23 July 2015, as they do not meet the labelling criteria as required under paragraph 34(1)(c)

of the Agvet Code.

The APVMA has issued instructions for the possession, supply and use of cancelled product or registered product

bearing a cancelled label until 23 July 2016 as noted below.

Further Information

Further details can be found in the APVMA’s Fenamiphos Review Findings Report and Regulatory Decision. Copies of

the report or further information can be obtained from the APVMA website, www.apvma.gov.au or by request to

Chemical Review.

APVMA CONTACT

CHEMICAL REVIEW


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776






Table 1: Affirmed active constituent approvals for fenamiphos

(i) Approval no. (ii) Approval holder

51157 Amgrow Pty Ltd

55043 4 Farmers Australia Pty Ltd

56591 Imtrade Australia Pty Ltd

67708 Amvac C.V

70200 Amvac C.V

Table 2: Affirmed registered products containing fenamiphos and the cancelled and new label approval numbers.

(iii)

Product

number

(iv) Product name (v) Registrant (vi) Cancelled label

approval number

(vii) Affirmed

new label

approval number

33293 Nemacur 100G Nematicide Amgrow Pty Ltd

33293/100185 33293/0198 33293/0803 33293/1209 33293/55718

33293/0715

33295 Nemacur 400 Nematicide Amgrow Pty Ltd

33295/1209 33295/03 33295/0198 33295/0399 33295/1103

33295/0715

56946 Imtrade Assassinator 400

Insecticide Imtrade Australia Pty Ltd

56946/51030 56946/0204

56946/0715

62234 Country Fenamiphos 400

Nematicide Liquid Accensi Pty Ltd

62234/101311 62234/0707 62234/0709 62234/53392 62234/59913

62234/0715

62574 4Farmers Fenamiphos 400

Nematicide and Insecticide 4 Farmers Australia Pty Ltd

62574/61705 62574/0408 62574/60914

62574/0715

64407 AW Sowon Insecticide Agri West Pty Limited 64407/100841 64407/1109

64407/0715

65039 AC Redback Insecticide Axichem Pty Ltd 65039/0510 65039/0715

65405 Titan Fenamiphos 400

Nematicide Liquid Titan Ag Pty Ltd 65405/50847 65405/0715

65756 Rainbow Fenamiphos 400

Nematicide and Insecticide

Shandong Rainbow

International Co., Ltd 65756/51801 65756/0715

66451 Mission Fenamiphos 400

Insecticide

Mission Bell Holdings Pty

Ltd 66451/53668 66451/0715

66614 Genfarm Fenamiphos 400

Nematicide

Landmark Operations

Limited 66614/53996 66614/0715



(iii)

Product

number

(iv) Product name (v) Registrant (vi) Cancelled label

approval number

(vii) Affirmed

new label

approval number

68795a Smart Fenamiphos 400 EC

Insecticide Crop Smart Pty Ltd 68795/59099 68795/0715

69011a Farmalinx Neptune 400 EC

Nematicide and Insecticide Farmalinx Pty Ltd 69011/59643 69011/0715

69146a

Sabakem Fenamiphos

400EC Nematicide and

Insecticide

Sabakem Pty Ltd 69146/60077 69146/0715

70057a Surefire Neemat

Nematicide & Insecticide PCT Holdings Pty Ltd 70057/62403 70057/0715

a products that have been registered since the Preliminary Review Findings report.

Table 3: Cancelled product registrations and label approvals as an outcome of the fenamiphos review

(viii)

Product

number

(ix) Product name (x) Registrant (xi) Label approvals

cancelled

62093 Barmac Electricur Turf Nematicide Amgrow Pty Ltd 62093/0309 62093/100182

INSTRUCTIONS FOR USE FOR FENAMIPHOS PRODUCTS BEARING A CANCELLED LABEL

The following instructions set out how a person can deal with:

the cancelled products listed in Table 3 above; or

products bearing the cancelled labels listed in Column D of Table 2 above.

SUPPLY

A person may supply or cause to be supplied cancelled product or product bearing the cancelled labels manufactured

prior to 23 July 2015 at wholesale and retail level, until 23 July 2016.

After 23 July 2016 it will be an offence against the Agvet Codes to have possession or custody of the cancelled product

or product bearing the cancelled labels with the intention to supply, or to supply the cancelled product or product bearing

the cancelled labels.

USE

A person may continue to use the cancelled product or product bearing the cancelled labels according to its label

instructions until 23 July 2016.

Any person who possesses, has custody of, uses, or otherwise deals with the cancelled product or product bearing the

cancelled labels in accordance with the above instructions is taken to have been issued with a permit under the Agvet

Codes to so possess, have custody of, use or otherwise deal with the cancelled product or product bearing the cancelled

labels after the registration or label approvals has been cancelled until 23 July 2016.



The supply and use of the cancelled product or products bearing the cancelled labels must be in accordance with the

conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

Warning

It is an offence to possess, have custody of, use, or deal with the cancelled product or product bearing cancelled labels

listed in Table 2 and 3 in a manner that contravenes the above instructions.

APVMA CONTACT

Manager Chemical Review


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776




Licensing of Veterinary Chemical Manufacturers


Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary

Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of the

following veterinary chemical manufacturers, with effect from the dates shown.

For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.

1. NEW LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code]

SCIENTEST ANALYTICAL

SERVICES PTY LTD

LICENCE NO: 6204

ACN: 116 585 936

6/22 Mavis Court

ORMEAU QLD 4208

Product Types:*

Category 6: Single step manufacture

Step(s) of Manufacture: Analysis and testing (physical and chemical)

Licence Issued: 7 April 2015

LANDMARK OPERATIONS

LIMITED

LICENCE NO: 6201

ACN: 008 743 217

Suite 3, Level 1, Building B

11 Talavera Road

MACQUARIE PARK NSW 2113

Product Types:*


Step(s) of Manufacture: Release for supply


BIOCSL PTY LTD LICENCE NO: 1106

ACN: 160 735 035

39–79 Poplar Road

PARKVILLE VIC 3052

Product Types:*

Category 1: Immunobiologicals and Sterile products

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, aseptic filling, packaging, labelling, freeze-drying, sterilisation

(filtration), microbiological reduction treatment (filtration), analysis and testing

(physical, chemical, endotoxin, microbiological, sterility testing, serological,

immunobiological) and storage.





NHB ENTERPRISES PTY

LIMITED

LICENCE NO: 2235

ACN: 144 796 878

Shop 1/304–318 Kingsway

CARINGBAH NSW 2219

Product Types:*

Category 2: Tablets, creams/lotions, ointments, pastes, granules, sprays,

liquids, suspensions and gels.


including blending, dry milling of powders, filling, granulation, wet milling of

powders, packaging, labelling, tableting, storage and release for supply.

Licence Issued: 12 June 2015

RURAL CHEMICAL

INDUSTRIES (AUST.) PTY.

LTD.

LICENCE NO: 6203

ACN: 003 842 402

Unit 4, 26 Kent Road

MASCOT NSW 2020

Product Types:*


Step(s) of Manufacture: Quality assurance (QA) of raw materials, labelling,

storage and release for supply.


NORTHERN SERUMS PTY

LTD

LICENCE NO: 1108

ACN: 003 809 318

1/61 Centennial Circuit

BYRON BAY NSW 2481

Product Types:*

Category 1: Immunobiologicals (tick antiserum)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, management

and immunisation of donor animals, serum collection, formulation including

blending, aseptic filling, packaging, labelling, sterilisation (heat, chemical and

filtration), microbiological reduction treatment (heat and filtration), analysis and

testing (physical), storage and release for supply.


PIA PHARMA PTY LTD LICENCE NO: 2232

ACN: 150 999 974

Unit 3, 46 Buffalo Road

GLADESVILLE NSW 2111

Product Types:*

Category 2: liquids


including blending, filling, packaging, labelling, microbiological reduction treatment

(chemical), analysis and testing (physical and chemical), storage and release for

supply




2. CHANGES TO EXISTING LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code

AUSTRALIAN BLISTER

SEALING INCORPORATED

PTY LTD

LICENCE NO: 6148

ACN: 001 219 003

18 Distribution Place

SEVEN HILLS NSW 2147

Product Types: *


Step(s) of Manufacture: Packaging, labelling, strip, blister or sachet packaging

and storage

Amended Licence Issued: 1 April 2015

ZAMIRA LIFE SCIENCES PTY

LTD

LICENCE NO: 6184

ACN: 130 641 502

Level 1, Suite 4, 321 Whitehorse

Road

NUNAWADING VIC 3131

Product Types: *




DAVID GRAY & CO. PTY

LIMITED

LICENCE NO: 3003

ACN: 008 671 127

2 Rawlinson Street

O’CONNOR WA 6163

Product Types: *

Category 3: Liquids, sprays and powders.


including blending, filling, packaging, labelling, aerosol filling from bulk, analysis

and testing (physical), storage and release for supply.




AUSVETLAB PTY LTD,

TRADING AS AUSTRALIAN

VETERINARY SERUM

LABORATORIES, AS

TRUSTEE FOR DAVID K

JONES FAMILY SETTLEMENT

LICENCE NO: 1063

ACN: 001 611 516

105 Norman Jones Lane

ALSTONVILLE NSW 2477

Product Types: *

Category 1: Immunobiologicals (tick antiserum and snake antivenoms)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, serum

collection, management and immunisation of donor animals, formulation including

blending, aseptic filling, sterilisation (heat and filtration), microbiological reduction

treatment (heat and filtration), packaging and labelling, analysis and testing

(physical), storage, release for supply.


THE UNIVERSITY OF

MELBOURNE VETERINARY

HOSPITAL

LICENCE NO: 1078

ABN: 75 360 513 347

250 Princes Highway

WERRIBEE VIC 3030

Product Types: *

Category 1: Immunobiologicals (canine plasma, canine red blood cells

[RBC])

Step(s) of Manufacture: Quality assurance (QA) of raw materials, management

and immunisation of donor animals, blood collection, packaging, labelling,

analysis and testing (physical, chemical, haematological, microbiological and

immunological), separation of red cells and plasma, storage and release for

supply.


LIENERT AUSTRALIA PTY.

LTD.

LICENCE NO: 4085

ACN: 008 293 007

28 Durham Street

FORBES NSW 2871

Product Types: *

Category 4: Premixes, supplements


including blending, pellet extrusion, filling, packaging, labelling, analysis and

testing (physical), storage and release for supply.




CHEMINOVA (MFG) PTY

LIMITED

LICENCE NO: 2204

ACN: 132 767 956

16 Lucca Road

WYONG NSW 2259

Product Types: *

Category 2: powders, liquids, tablets (mineral supplements) and capsules

(intra-ruminal slow release)

Category 3: powders and liquids


including blending, dry milling, wet milling, filling, tableting, capsule filling from

bulk, oxidation of metal, packaging, labelling, sachet packaging, analysis and

testing (physical and chemical), storage and release for supply


TASMAN CHEMICALS PTY.

LIMITED

LICENCE NO: 2170

ACN: 005 072 659

1–7 Bell Grove

BRAESIDE VIC 3195

Product Types: *

Category 2: liquids and ointments


including blending, filling, packaging, labelling, analysis and testing (physical and

chemical), storage and release for supply


SYRINX PHARMACEUTICALS

PTY LTD

LICENCE NO: 2227

ACN: 149 728 825

110 Merrindale Drive

CROYDON VIC 3136

Product Types: *

Category 2: tablets, capsules (hard shell), creams/lotions, pastes, liquids,

powders and granules


including blending, dry milling, wet milling, granulation, filling, packaging, labelling,

blister and sachet packaging, tableting, tablet coating, capsule filling from bulk,

freeze drying, storage and release for supply




SLADE HEALTH PTY LTD LICENCE NO: 1099

ACN: 151 218 978

14 Palmer Court

MOUNT WAVERLEY VIC 3149

Product Types: *

Category 1: sterile injectables, sterile eye drops


including blending, aseptic filling, packaging, labelling, analysis and testing

(physical, microbiological), storage and release for supply.


INTERTEK TESTING

SERVICES (AUSTRALIA) PTY.

LTD. TRADING AS PROBE

ANALYTICAL

LICENCE NO: 6084

ACN: 001 722 854

Building 1

19–23 Paramount Road

WEST FOOTSCRAY VIC 3012

Product Types: *


Step(s) of Manufacture: Analysis and testing (chemical)


DELTA LABORATORIES PTY

LIMITED

LICENCE NO: 1056

ACN: 050 324 742

8 Warringah Close

SOMERSBY NSW 2250

Product Types: *

Category 1: Sterile products

Category 2: Creams/lotions, ointments, pastes, sprays and liquids


including blending, filling, aseptic filling, packaging, labelling, sterilisation (heat

and filtration), microbiological reduction treatment (filtration), analysis and testing

(physical, chemical and microbiological), storage and release for supply.


ELANCO ANIMAL HEALTH

A DIVISION OF ELI LILLY

AUSTRALIA PTY LTD

LICENCE NO: 6150

ACN: 000 233 992

112 Wharf Road

WEST RYDE NSW 2114

Product Types: *






AGRICON PTY LTD TRADING

AS: AGRICON PRODUCTS

LICENCE NO: 4002

ACN: 010 147 958

Lot 13, Enterprise Street

Industrial Estate

MARYBOROUGH QLD 4650

Product Types: *

Category 4: Premixes and supplements

Step(s) of Manufacture: Quality assurance (QA) raw materials, formulation

including blending, dry milling, filling, packaging, labelling, analysis and testing

(physical), storage and release for supply


MARS AUSTRALIA PTY LTD

TRADING AS MARS PETCARE

AUSTRALIA

LICENCE NO: 2106

ACN: 008 454 313

Petcare Place

WODONGA VIC 3690

Product Types: *

Category 2: Palatable ingestible chews


including blending, filling, packaging, labelling, strip, blister or sachet packaging,

microbiological reduction treatment (heat), analysis and testing (physical and

chemical), storage and release for supply


PHARMASYNTH PTY LTD LICENCE NO: 1086

ACN: 074 656 509

2806 Ipswich Road

DARRA QLD 4076

Product Types: *

Category 1: vaccines

Step(s) of Manufacture: Quality assurance (QA) of raw materials, cell

propagation, virus cultivation, filling, packaging, labelling, sterilisation (heat and

filtration), microbiological reduction treatment (heat, filtration and chemical),

analysis and testing (physical), storage.


CATALENT AUSTRALIA PTY

LTD

LICENCE NO: 2059

ACN: 007 219 990

217–221 Governor Road

BRAESIDE VIC 3195

Product Types: *

Category 2: Tablets and capsules


including blending, premixing in powder or granular form, filling, packaging,

labelling, blister packaging, soft gelatine capsule manufacture, hard shell capsule

manufacture, tableting, tablet coating, analysis and testing (chemical), storage

and release for supply

Amended Licence Issued: 28 May 2015



SUNNYFIELD LICENCE NO: 6158

ACN: 000 415 127

185 Allambie Road

ALLAMBIE HEIGHTS NSW 2100

Product Types: *


Step(s) of Manufacture: secondary packaging, secondary/supplementary

labelling, storage

Amended Licence Issued: 10 June 2015

MEDICAL DEVELOPMENTS

INTERNATIONAL LIMITED

LICENCE NO: 2196

ACN: 106 340 667

Building 5, 6, 7, 8 and 10

56 Smith Road

SPRINGVALE VIC 3171

Product Types: *

Category 2: Liquids (Methoxyflurane only)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, chemical

synthesis, filling, packaging, labelling, secondary packaging,

secondary/supplementary labelling, storage and release for supply.


MODERN ARK PTY LTD LICENCE NO: 2215

ACN: 104 514 801

10 Activity Street

WARWICK QLD 4370

Product Types: *

Category 2: Tablets, creams/lotions, ointments, pastes, granules,

powders, sprays, liquids, gels and suspensions

Category 3: liquids, pastes, sprays, powders and collars

Category 4: premixes and supplements


including blending, dry milling of powders, wet milling, granulation, tableting,

filling, packaging, labelling, strip, blister or sachet packaging, analysis and testing

(physical and chemical – pH only), storage and release for supply.


ANIMAL CONSULTING

ENTERPRISES PTY. LTD.

LICENCE NO: 1081

ACN: 115 191 056

12 Gildea Lane

BENDIGO EAST VIC 3550

Product Types: *

Category 1: Immunobiologicals (bacterial vaccines)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial

fermentation, formulation including blending, aseptic filling, sterilisation (heat),

microbiological reduction treatment (heat, chemical), packaging, labelling,

analysis and testing (physical, chemical, microbiological, sterility test), storage

and release for supply.




TSI PHARMACEUTICALS PTY

LTD

LICENCE NO: 2226

ACN: 052 101 176

262 Evans Road

SALISBURY QLD 4107

Product Types: *

Category 2: Creams/lotions, ointments, pastes, sprays and liquids (oral

and topical)

Category 3: Liquids, pastes and sprays

Category 4: Supplements (liquids)


including blending, filling, packaging, labelling, analysis and testing (physical),



ENDEAVOUR FOUNDATION LICENCE NO: 6161

ACN: 009 670 704

12–16 Leabons Lane

SEVEN HILLS NSW 2147

Product Types: *


Step(s) of Manufacture: Packaging, labelling, strip, blister or sachet packaging,



PADULA SERUMS PTY. LTD. LICENCE NO: 1105

ACN: 167 348 610

26 Howitt Ave

BAIRNSDALE VIC 3875

Product Types: *

Category 1: Immunobiologicals (snake antivenom, tetanus antitoxin and

equine plasma products).

Step(s) of Manufacture: Quality assurance (QA) of raw materials, blood

collection, plasma separation, management and immunisation of donor animals,

labelling, analysis and testing (physical, chemical, serological, immunobiological,

mouse bioassay for potency), storage and release for supply.


SYPHARMA PTY. LTD. LICENCE NO: 1082

ACN: 114 895 064

27 Healey Road

DANDENONG VIC 3175

Product Types: *

Category 1: Sterile products

Category 2: Creams/lotions, ointments, pastes, powders, liquids and

suspensions

Category 3: Liquids

Category 4: Premixes and supplements


including blending, wet milling, filling, aseptic filling, packaging, labelling,

microbiological reduction treatment (filtration and heat), sterilisation (heat and

filtration), analysis and testing (physical, chemical, microbiological,

immunobiological, Limulus Amoebocyte Lysate [LAL] test and sterility testing),





RTH SCIENTIFIC SERVICES

PTY LTD

LICENCE NO: 6166

ACN: 112 358 915

47 Oak Place

MACKENZIE QLD 4156

Product Types: *


Step(s) of Manufacture: Analysis and testing (physical and chemical)


3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code].

GEORGE WESTON FOODS

LIMITED TRADING AS

GEORGE WESTON

TECHNOLOGIES ANALYTICAL

SERVICES

LICENCE NO: 6100

ACN: 008 429 632

1 Braidwood Street

ENFIELD NSW 2136

Date Cancelled: 9 April 2015

LANDMARK OPERATIONS

LIMITED

LICENCE NO: 2230

ACN: 008 743 217

24–26 Hydrive Close

DANDENONG VIC 3175

Date Cancelled: 25 June 2015

RURAL CHEMICAL

INDUSTRIES (AUST.) PTY.

LTD.

LICENCE NO: 6094

ACN: 003 842 402

Unit 5, 7–9 Kent Road

MASCOT NSW 2020




EIMERIA PTY LIMITED LICENCE NO: 1036

ACN: 075 153 472

University of Melbourne

School of Veterinary Science

WERRIBEE VIC 3030


4. LICENCE SUSPENSIONS

The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [the Agvet Code].

AUSTRALIAN ANIMAL BLOOD

BANK PTY LTD

LICENCE NO: 1101

ACN: 140 128 990

50 Wills Road

LONG POINT NSW 2564

Date Suspended: 26 June 2015 (to 13 August 2015)

5. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and

Veterinary Chemicals Code [the Agvet Code].

Nil

6. REVOCATION OF LICENCE SUSPENSION

The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and

Veterinary Chemicals Code [the Agvet Code].

Nil

APVMA CONTACT

Manufacturing Quality and Licensing Section

Compliance and Legal Program


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4889

Fax: +61 2 6210 4813




Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992

Appointment of Approved Analysts—Subsection 69G(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992

Notice is hereby given that the persons described in Schedule 1 below were duly appointed on 14 July 2015 in

accordance with subsection 69G (1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as approved

analysts for the purposes of the Agvet Codes.

Schedule 1

Appointment Number: AN087

Dr Mark Lewin

Advanced Analytical Australia Pty Ltd

11 Julius Ave

North Ryde NSW 2113

Appointment Number: AN088

Dr Rama Nimmagadda

Advanced Analytical Australia Pty Ltd

11 Julius Ave

North Ryde NSW 2113

APVMA CONTACT

Compliance and Monitoring

Compliance and Legal Program


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4821

Fax: +61 2 6210 4813



apvma gazette no. 15, 28 july 2015 · summary of use for the protection of buildings and other...

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