This content is current only at the time of printing. This document was printed on 5 July 2020. A current copy is located at https://apvma.gov.au/node/28771
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Regulatory Update #264
Reminder: Waiver period for eligible veterinary active constituent applications ends 31 January 2018
In June 2017 we extended the period to waive, partially waive or refund fees associated for some eligible veterinary active constituent applications until the end of January 2018. This applies to Item 17 and Item 18 applications for veterinary active constituents which meet the scope of the Veterinary Actives Project as outlined below:
- Where the holder of a registered veterinary product is requesting approval of their active constituent (an Item 17 application full fee waiver $3 155).
- Where the holder of an approved active constituent is requesting an additional site of manufacture for their active constituent with no changes to the manufacturing standard, composition or purity of the active constituent (an Item 18 application full fee waiver $2 465).
- When an applicant is requesting approval of an active constituent and is manufactured to a pharmacopoeia standard, with limited non-protected application data available and has no currently registered products (an Item 17 application partial fee waiver $2 445, the amount of $710 is payable).
This waiver period will cease on Wednesday 31 January 2018. Applications received after this date will be subject to full fees for the relevant item number. We encourage all holders of registered veterinary products sourcing an active constituent which is not APVMA approved to contact our veterinary actives team by email at firstname.lastname@example.org or phone 02 6210 4984.
APVMA archive website decommissioned
The APVMA archive site was decommissioned on Wednesday 20 December 2017.
Thank you to everyone that submitted feedback in response to our call for comments in Regulatory Update #261. Your comments have been taken into account and all content of value has been migrated to the current APVMA website. As an exception to the decommissioned content, application summaries remain accessible online. The decision to decommission the archive site is part of our ongoing commitment to improve user experience through enhancing the information and functionality of our website.
If you need to access the APVMA archive site, please do so through the National Library of Australia web archive.
Proposed approach to spray drift management—now open for consultation
On Monday 18 December 2017 we published a draft proposal for the APVMA's spray drift management approach. The proposal is now open for consultation for approximately three months.
The purpose of the proposed spray drift management approach is to enable clearer label instructions, increased flexibility and support of drift reducing technologies.
The proposed spray drift management approach is currently open for consultation. Please submit your submissions before close of business on Friday 30 March 2018.
Compulsory recall of Zinsser Mould Stop Primer upheld by Administrative Appeals Tribunal
Chemical manufacturer, Rust-Oleum Australia Pty Ltd, is pulling all stocks of Zinsser Mould Stop Primer from the market after a compulsory recall notice that we issued was upheld by the Administrative Appeals Tribunal (AAT).
The product has been recalled as it was unregistered, and therefore had not gone through our scientific assessment and registration processes. During its review, the AAT ordered a stay on the recall and the product continued to be sold in stores.
Consumers who have bought Zinsser Mould Stop Primer are advised to contact the retailer they purchased the product from for further information about the recall and returns process.
All information about compulsory and voluntary recalls can be found on our website.
Armidale business operating model—now finalised
We released our finalised business model for operations in Armidale on
Tuesday 19 December 2017.
The business model has been developed from recommendations made by specialist consulting firm Pegasus Economics and provides a level of flexibility that can be adjusted as the agency develops a clearer picture of staff relocation intentions, industry capacity and the availability of infrastructure in Armidale.
A concept diagram of the business operating model, the Armidale organisational chart 2019 and the report from Pegasus Economics are now available on the APVMA website.
Crop groups listing updated
The Crop groups listing on our website has been updated following revisions from the 2017 Codex Committee on Pesticide Residues.
These updates have been carried out as part of our work in improving access to chemicals for growers of minor crops, as well as streamlining data and assessment requirements for registrants.
Updated guidance documents now available
The following guidance documents have been updated for the December 2017 quarter.
- The Acute Reference Doses (ARfD) for Agricultural and Veterinary Chemicals Used in Food Producing Crops or Animals. You can view information on the updated ARfDs from December 2017 on our website.
- The Handbook of First Aid Instructions, Safety Directions, Warning Statements and General Safety Precautions for Agricultural and Veterinary Chemicals (FAISD Handbook). You can view full details of amendments made to the FAISD Handbook from December 2017 on our website.
- The Acceptable Daily Intakes (ADI) for Agricultural and Veterinary Chemicals Used in Food Producing Crops or Animals. You can view the updated ADIs from December 2017 on our website.
Reminder—open for public consultation
We regularly seek input throughout chemical registration and review processes, and other operational and regulatory processes. We are currently seeking input on the following open consultations:
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code - 2 January 2018
- Proposed registration of Serenade Opti Biofungicide containing the new active constituent, Bacillus amyloliquefaciens strain QST 713 - 9 January 2018
- Macrolide antibiotics (kitasamycin, oleandomycin and tylosin) Proposed Regulatory Decisions - 28 February 2018
- Seeking comment on the APVMA’s proposed approach to spray drift management - 30 March 2018
- Phone our general enquiries number: +61 2 6210 4701
- Email: email@example.com
- Our mailing address is:
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston, Australian Capital Territory 2604
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