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This edition of the APVMA eNewsletter comes as we look forward to the challenges of the new financial year. It sees us implementing the new cost recovery framework, with a lot of effort directed at ensuring it proceeds as smoothly as possible. A key associated activity has been a complete revision of our Manual of Requirements and Guidelines. This major undertaking provides clear information on requirements for different types of applications and also gives the first major updates of APVMA requirements and guidelines since their inception. I am confident it will make a significant contribution to the quality and efficiency of both the preparation and evaluation of registration and permit applications. We also go forward focussed on delivering the goals of our new Operational Plan for 2005-06, recently approved by the Board and Senator Colbeck, Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry. This ambitious plan, prepared for the second time using Balanced Scorecard Methodology that clearly links strategy and actions to corporate goals, has a strong focus on improving operational excellence and stakeholder confidence. Within it priority areas, reflective of stakeholder feedback, include registration efficiency and quality, transparency, strengthening compliance and minor use. I look forward to working with you to achieve the outcomes of the Plan, which will soon be available on our website. Dr Joe Smith |
THE LATEST
New Cost Recovery arrangements
New cost recovery arrangements come into force 1 July 2005. A A brochure explaining the new arrangements along with the the Regulations containing the new fee schedules are available on our website.
You Can Now Pay Your Annual Fee Online
A new online (web based) payment facility is now up and running. The new annual fee is $390 per product (regardless of sales). This fee maintains a product's registration for a financial year. The fee replaces the registration renewal fee, which ranged from $200 - $1,000. Payment of the annual fee is due by 30 June 2005 to maintain product registration for the 2005-06 financial year. Late payment fees of $50 per product apply if received by the APVMA after the due date. All registrants should now have received their login ID and password to access the new system. If you haven't received your login details please contact Lisa Reaney on (02) 6272 4851.
Levy Payments are Due by 31 July 2005
Due to the migration from Calendar Year sales declarations to Financial Year sales declarations the existing on-line levy payment facility has been suspended for 12 months. Levy notices have now been despatched by traditional post.
The levy payments are due by 31 July 2005. Because of the change from calendar year sales to financial year sales, the payment due on 31 July 2005 is based on sales made during the six month period 1 January 2004 - 30 June 2004. There is no option to pay this six monthly levy by instalments.
In July 2005, sales will be requested for the period 1 January 2005 - 30 June 2005. These sales will be combined with those already declared for the last six months of the 2004 calendar year, to form the 2004-05 financial year declaration.
Levy payment for sales made during the 2004-05 financial year will be due on 31 December 2005 (payable by two equal instalments, with the balance due on 30 June 2006).
Manual of Requirements and Guidelines
APVMA is in the process of updating its Ag and Vet Requirements series. The updated series will be called the Manual of Requirements and Guidelines (MORAG). New application fees and application categories come into effect from Friday 1 July.
Information on the new application categories can be found in MORAG which will be available from 1 July on our website. An announcement will be placed on the front page of the website at this time.
The APVMA has recently conducted seminars on the new fees and categories in Brisbane, Sydney, Melbourne, Adelaide and Perth. MORAG will be distributed primarily by the website. The MORAG binder, volume and chapter dividers are available, free of charge, from the APVMA contact officers.
Key Outcomes of Board Meetings
Summaries of key outcomes of Board of Directors meetings can now be viewed on the APVMA website.
Minor Use Happenings
Proposals for minor use reform were discussed at a stakeholder forum on 25 May and agreed in principle by the Product Safety and Integrity Committee. Detailed proposals will now be considered further by PSIC and the Primary Industries Standing Committee.
Good Laboratory Practice
Principal Scientist Phil Reeves participated in the GLP Residues Workshop hosted by the Veterinary Manufacturers and Distributors Association, held in Melbourne on 5 May. Phil presented the APVMA perspective on GLP residues data requirements. Other speakers discussed the perspectives of NATA, the sponsor, the contract researcher, and the QA Manager. The workshop was very well received by the chemical industry, as indeed was the GLP Residues Workshop held in Sydney in October 2004.
OECD
Eva Bennet-Jenkins recently participated in the OECD Working Group on Pesticides where among other things she presented a paper on minor use reform. As part of the ongoing APVMA engagement with the OECD harmonisation of test guidelines for registration, Raj Bhula attended a second meeting of the Expert Group on Pesticide Residue Chemistry in May. At the meeting 5 guidelines and 2 guidance documents were finalised and will be sent out for comment by member government experts in July.
Raj chaired the Working Group that produced the final version of the livestock feeding guideline. Work will continue on developing an OECD policy document on setting MRLs for animal commodities. This work is important to APVMA to ensure that Australia's obligations with respect to trade are highlighted through internationally harmonised guidelines and policy. This is particularly crucial in the area of livestock feeding, animal MRLs and trade and the recognition of Australian MRLs for meat and animal commodities by our major trading partners
Quality Scheme for Agricultural Active Constituents and Products
As noted in the last newsletter, the APVMA will begin formal auditing of records under this scheme in July 2005. We aim to audit at least 10 companies and require data call-ins on 100 pesticide products in the 2005-06 financial year. In addition we expect to be testing approximately 60 products for active constituents and impurities described in the APVMA Standards.
Memorandum of Understanding (MOUs) with Canadian Regulators
The APVMA has recently signed an MOU with its counterpart Canadian veterinary medicines regulator (the Veterinary Drugs Directorate, VDD). This follows the signing of a similar MOU in October last year with the Canadian pesticide regulator, the Pest Management Regulatory Agency (PMRA). These agreements provide a solid framework for cooperation across the full range of regulatory activities and offer potential mutual benefits in terms of both quality and cost efficiency. The APVMA is working with VDD and PMRA to implement specific workplans within the respective MOUs. Senator Colbeck's announcement of the MOUs.
Memorandum of Understanding With NZFSA
The APVMA has also signed a memorandum of understanding (MOU) with the New Zealand Food Safety Authority Agricultural Compounds and Veterinary Medicines Group. The MOU between APVMA and NZFSA formalises processes for the mutual acceptance of licences for the manufacture of veterinary medicines following Good Manufacturing Practice principles.
Draft Veterinary Chemical Products Manufacturing Principles and Australian Code of GMP for Veterinary Medicines
We anticipate releasing the above documents and a consultation Regulatory Impact Statement for public comment in mid August before the next newsletter. The draft documents have been revised, for the first time since their inception, in close consultation with industry representatives.
GMP Auditors Workshop
On 26 May, the APVMA held a one-day workshop for APVMA-authorised auditors. The APVMA presented current auditing issues and encouraged feedback from auditors on the auditing process. The draft revised GMP Code was also discussed.
A New and Improved PUBCRIS is Coming
Work is now well advanced in the redesign of the PUBCRIS database interface. The enhancements are in response to feedback we have received from PUBCRIS users. Some of the changes you will see to the database when the new interface is released are listed below:
- the ability to undertake product searches between two registered dates
- the ability to search by poison schedule and formulation
- the ability to search for products by product type and utilise lookup lists for actives, hosts and pests
- a "paging" system allowing a better display of large search results
- the incorporation of active constituents appearing in search results and the display of withholding periods
- the display of data protection information
- improved "printer friendly" capabilities
- the ability to download search results
- an improved look and feel
It is hoped to launch the new PUBCRIS before the end of September 2005.
Chemical review news
1080 Review
The report of the Preliminary Review Findings for 1080 has been released for public comment. The closing date for comment is 31 August 2005.
Methiocarb Review
The report of the Preliminary Review Findings for methiocarb has been released for public comment. The closing date for comment is 31 July 2005.
Endosulfan
The APVMA has finalised the Review Findings and Regulatory Outcomes for endosulfan. The Final Review report will be released in July.
Diuron
The Preliminary Review Findings report for diuron will be released in July for public comment.
Pesticide and Veterinary Reviews Status to 1 June 2005
Status summaries for pesticides and veterinary medicines reviews
Auditing pesticide records to begin July 2005
Methiocarb review
1080 Review
Additional information on new fee structure and fees brochure
Outcomes of of Board of Directors meeting
New brochure on on Overview of Australia's National System for Managing Agricultural and Veterinary Chemicals
June Gazette
May Gazette
Updateded MRL Standard