Public Consultation

Spinetoram in the product Delegate Insecticide

The APVMA invites comment on whether the application for registration of the product Delegate Insecticide with active constituent spinetoram should be granted.

Download the Public Release Summary (PDF - 540KB)

Please provide written comments by post fax or email by 8 September 2008 to:

Pat Robinson
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Telephone: 02 6210 4756
Fax: 02 6210 4776

Virbac Nitromec Injection Endectocide and Flukicide for Cattle

Comments are sought on the potential for Virbac Nitromec Injection Endectocide and Flukicide for Cattle to unduly prejudice Australian export trade when used according to the proposed directions.

Download the Trade Advice Note (PDF - 638KB)

Please provide written comments by post fax or email by 2 September 2008 to:

Dr Judith Platt
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Telephone: 02 6210 4735
Fax: 02 6210 4741

 

Ectoparasiticide Guidelines

The APVMA is proposing to adopt World Association for the Advancement of Veterinary Parasitology (WAAVP) guidelines for evaluating the efficacy of ruminant extoparasiticides .

The APVMA has written a preamble to each WAAVP guideline which will clarify how many trials are required, where they should be performed, the strains of ectoparasites to be used where applicable, clarification on claims, efficacy requirements, and any other pertinent information. These preambles have been the focus of considerable targetted consultation.

The APVMA seeks comments on the draft guidelines, intended for inclusion in a later edition of the Manual of Requirements and Guidelines for registering veterinary products (Vet MORAG). Comments and feedback will be taken into consideration in developing the final guidelines.

Download the Draft guidelines (PDF - 75KB)

If adopted the WAAVP guidelines will replace existing APVMA guidelines 16-23 that can be found in Vet MORAG Volume 4

Please provide your written comments by post, fax and email by 1 September 2008 to:

Veterinary Products Coordinator
Veterinary Medicines Program
APVMA
PO Box 6182
KINGSTON ACT 2604
Fax: 02 6210 4813

Adverse Experience Reporting Program for Agricultural Chemicals - review of the registration component

The APVMA is reviewing the registrant component of the APVMA's Adverse Experience Reporting Program for Agricultural Chemicals (AERP Ag). The review will examine whether the registrant component continues to meet its original objectives and to identify any necessary modifications. The review addresses a commitment made in the Regulation Impact Statement for the Adverse Experience Reporting Program for Agricultural Chemicals released June 2004. To receive updates on the review's progress please register your interest via email to: aerpcoordinator@apvma.gov.au

Additional reading

Please provide your written comments by post, fax or email by
10 October 2008 to:

Dr Elvira Currie
Adverse Experience Reporting Program
Review- AERP Section
APVMA
PO Box 6182
KINGSTON ACT 2604
Fax: 02 6210 4813

Proposal to modify Table 2 of the APVMA Maximum Residue Limit Standard with reference to fatty tissues

The APVMA seeks comments on a proposal to modify entries in Table 2, Class B: Primary Food Commodities of Animal Origin, of the MRL Standard relating to fatty tissues. The entries describe the portion of the commodity to which the MRL applies, and which is analysed in the determination of residues. Comments and feedback relating to the proposal will be considered.

Download the Consultation Notice (PDF - 24KB)

Please provide your written comments by post, fax or email by
23 September 2008 to:

Dr Robert Munro
Manager, Veterinary Residues
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Ph: 02 6210 4832
Fax: 02 6210 4741

 

Guidelines for the Registration of Agricultural Adjuvant Products

The APVMA seeks comments on a draft guideline intended for inclusion in a later edition of the Manual of Requirements and Guidelines for registering agricultural products (Ag MORAG). Comments and feedback will be taken into consideration in developing the final guideline.

Download the draft guideline (adobe acrobat filePDF - 68KB)

Please provide your written comments by post, fax or email by
31 August 2008 to:

Jay Kottege
Principal Evaluator
Pesticides Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Ph: (02) 6210 4759
Fax: (02) 6210 4776

 

Review of the Overseas GMP Scheme

The APVMA invites any person to submit written comments with respect to the proposed review of the APVMA's Veterinary Post-Registration Overseas Good Manufacturing Practice (GMP) Compliance Scheme (Overseas GMP Scheme). The Overseas GMP Scheme ensures that imported veterinary medicines are manufactured in GMP compliant facilities, in order to improve consumer confidence in their quality and safety. The proposed review will examine whether the Overseas GMP Scheme is meeting its original objectives and to identify any necessary modifications.

Download the Review of the Overseas GMP Scheme Consultation Paper (adobe acrobat filePDF - 68KB)

Please provide your written comments by post, fax or email by
29 August 2008 to:

Dr Toni Pike
Overseas GMP Post-Registration Scheme Review
GMP Section
APVMA
PO Box 6182
KINGSTON ACT 2604
Fax: 02 6210 4813


Dichlorvos review - Preliminary Review Findings Released

The APVMA has released its preliminary review findings of dichlorvos, an organophosphorus insecticide commonly used for the control of a large variety of insects in storage areas in domestic, commercial and industrial premises. As a result of its findings the APVMA is proposing to add require new instructions on product labels to improve worker and environmental safety.

The APVMA is seeking your comments to assist the APVMA in preparing the Review Findings report, which is the second report in the three-stage review reporting process. The final report is the Final Review Report and Regulatory Decision.
Read details of the review so far

Download the Dichlorvos Preliminary Review Findings (PDF - 705KB)

Please provide your written comments by post, fax or email by close of business
3 September 2008 to:

Evaluator, Dichlorvos Review
APVMA
PO Box 6182
KINGSTON ACT 2604
Fax: 02 6210 4776

Responses to consultation processes

Proposal that applicants may submit an expert report with efficacy data

In August 2007 the APVMA invited comments on a proposal that if they wish, applicants may submit an expert report to accompany the efficacy data they submit in support of an application to register a product, or vary a registered product.

The APVMA is considering the responses before taking the next steps with this proposal.

Download a summary of the responses (adobe acrobat file PDF - 41KB)