Regulatory Update #269

Tailored Guidance Workshop gathers feedback from industry

On Wednesday 28 March 2018 we hosted 25 members of the agvet chemical industry at our office in Canberra where we workshopped ways to improve application guidance.

It was all about listening to what our clients had to say and collaborating on the improvements we can make to the current application guidance. We know that by improving your access to information we can make the application process more efficient and this will make assessments easier.

For those who couldn't make the workshop there is still a way for you to provide valuable feedback. Complete the client service and stakeholder survey on our website now.

Regulatory decisions on macrolide antibiotics finalised

We have released the final decisions from our review of macrolide antibiotics kitasamycin, oleandomycin and tylosin. These regulatory decisions include more robust label instructions to ensure prudent antibiotic use in pigs, registration cancellations and additional label statements encouraging users to investigate non-antibiotic treatment options. Full details of the regulatory decisions are outlined in the macrolide antibiotics regulatory decisions report, which was published on 6 April 2018.

This review was initiated due to concerns about antibiotic resistance and the potential risks to human health from the transfer of antibiotic resistance from animals to humans. The regulatory decisions outlined in the report will reduce the over-prescription of antibiotics, a major causes of antimicrobial resistance.

More information about the review is available on the macrolide antibiotics chemical review page of our website. 

Updated guidance documents now available

The following guidance documents have been updated for the March 2018 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 March 2018 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 March 2018 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 March 2018 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:

• New active afidopyropen in the product Versys Insecticide - 10 April 2018
• New active constituent florpyrauxifen-benzyl (Rinskor™) in the product GF3301 Herbicide - 10 April 2018
• Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code - 10 April 2018
• Proposed registration of Vanguard C4 Injectable Vaccine for Dogs containing four new active constituents - 24 April 2018
• Polihexanide: Proposed Regulatory Decisions - 27 April 2018

Contact us

• Phone our general enquiries number: +61 2 6210 4701
• Email: enquiries@apvma.gov.au
• Our mailing address is:

Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston, Australian Capital Territory 2604
Australia

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