This content is current only at the time of printing. This document was printed on 11 December 2019. A current copy is located at https://apvma.gov.au/node/20751
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Regulatory update #240
Clethodim samples make the grade
The APVMA Compliance and Monitoring team are pleased with the results received following testing of clethodim products. In late June 2016, APVMA inspectors conducted random sampling of registered clethodim products supplied in the Central West region of New South Wales. Samples were obtained from rural retail stores and submitted to an authorised laboratory for chemical analysis.
The labels and use instructions of the sampled clethodim products were also audited by the APVMA label monitoring program. All of the sampled labels and use instructions were found to be fully compliant.
Results obtained from the chemical analysis did not indicate any issues requiring compliance action.
Upcoming monitoring will test trifluralin, meloxicam and fipronil samples, in line with the Annual compliance plan 2016–17.
Notifiable variations—additions to list
The APVMA has expanded the list of notifiable variations to make low-risk changes to products, formulations and labels more efficient. The additional changes can now be accepted via the online services portal. Further information is available on the APVMA website.
Fast track registration success
The APVMA has registered its first product—a repack (Item 8) application—through the fast track pilot, an initiative of the lower regulatory approaches to registration project.
The application was finalised in six working days. The application was successful due to the provision of all information at lodgement, payment of the full application and, most importantly, the proposed label was identical to that of the reference product (except where variations are allowed under an Item 8). We encourage others who have a repack application (must hold both the reference product and proposed product) to consider participating in the fast track pilot.
Canberra industry information session—program now available
The program for day one of the Canberra industry information and education session is now available.
Day one (Tuesday 8 November) of the program will focus on regulatory science and innovation in the global context and day two (Wednesday 9 November) will be an update on important registration-related topics.
For more information and to register please see our events page.
Acting Director Manufacturing Quality and Licencing (MQL)
Commencing 17 October 2016, Susan Hanns will take on the role of Acting Director MQL. Susan is currently a Senior Risk Manager (Veterinary Ethicals and Antibiotics) with the APVMA, a major aspect of which involves providing regulatory, technical and administrative advice to internal and external stakeholders. Susan has been with the APVMA for 8 years and will bring to the Director’s role a strong background in the registration of veterinary chemical products and experience in working in a regulatory environment.
Help and assistance
Reminder—open for public consultation
- Proposed approval of human insulin and registration of the product prozinc insulin injection for cats–until 18 October 2016
- Proposed approval of clodronate disodium tetrahydrate and the registration of Osphos 51 mg/ml Solution for Injection for Horses–until 1 November 2016
- Proposed approval of terbinafine and registration of the product Osurnia Ear Gel for Dogs–until 1 November 2016
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code–until 1 November 2016
- Proposal to use New Zealand registration for Australian companion animal veterinary chemicals–until 4 November 2016