Regulatory Update #277

6 September 2018

CEO addresses the European Parliament's Special Committee

Our CEO, Dr Chris Parker, recently shared the Australian perspective on the regulation of plant protection products with the European Parliament's Special Committee on the EU's Authorisation Procedure for Pesticides.

Dr Parker told the Committee members about how Australia sets standards, which helps industry access innovative agvet products. The question and answer session provided a comparative analysis for the Committee between Australia and other OECD countries, including Canada and the USA.

"It was a great opportunity to discuss the harmonisation of agvet chemical regulation," Dr Parker said.

Reminder: Annual return of active constituents

Less than one month remains for you to report your active constituent data for the 2017–18 financial year.

All holders of approvals and registrations must report the amount of active imported, manufactured or exported each financial year and retain records of this information for six years.

Reports for 2017–18 financial year must be submitted by 30 September 2018.

Learn more and access the online reporting system.

Provide feedback on our proposed regulatory decisions on Methiocarb

On 27 August 2018 we published the Methiocarb Proposed regulatory decisions report. The report is now open for consultation for a period of three months.

Methiocarb is currently registered for use in the control of snails, slugs, false wireworm beetles, millipedes and slaters in a range of agricultural and home garden situations. After consideration of all data and assessments, we have concluded that methiocarb active approvals and product registrations can continue provided the product labels are varied to delete, add or amend certain use patterns, amend safety directions and first aid instructions, add restraint statements and amend withholding periods. The details of these amendments are outlined in the report.

Voluntary product recalls

Manufacturers have issued voluntary recalls for the following products:

  • Virbac Australia commenced a voluntary recall of Oralject Clair Gel Oral Bronchodilating Agent For Horses, APVMA Approval No: 38803, Pack size: 230 mL.

Virbac Australia advise there are no trade or safety issues and people who have the products listed should direct any questions to Virbac Australia.

  • Elanco Australasia commenced a voluntary recall of Purina Total Care Flea Knockdown For Cats, Puppies and Small Dogs and Purina Total Care Flea Knockdown For Medium and Large Dogs.

Elanco Australasia advise the recall is because of an ‘oversticker’ on the product containers that covers the active constituent and that there is no quality or safety impact for the product. People who have the products should direct any questions to Elanco Australasia.

Products can be recalled for a variety of reasons and we encourage manufacturers to issue a voluntary recall if an issue is detected. 

New tailored guidance material: reference products

We’re making registration easier with tailored guidance material that gives you the information you need to lodge the right application, with the right data and supporting evidence to meet APVMA criteria, before entering our online services portal.  

A fourth tailored guidance pathway, I want to register a product that is the same as a reference product is now available. This complements the following pathways:

By improving applicant guidance material we aim to make the registration process smoother and more efficient.

Learn more about tailored guidance for applicants

Reminder: Open for public consultation

We are currently seeking input on the following consultations:

Contact us

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

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