Fillable Notification of potential or actual recall of an (Department of Agriculture, Forestry and Fishing)

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Notification of potential or actual recall of an (Department of Agriculture, Forestry and Fishing)

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Page 1: Notification of potential or actual recall of an agricultural or veterinary chemical product
Notification of potential or actual recall of an agricultural or veterinary chemical
product
This form must be completed if you are seeking to recall an agricultural or veterinary chemical product (agvet product). A
notification of potential or actual recall must be lodged by a person who is authorised to act on behalf of the company
they represent.
Prior to submission of this notification, you must be familiar with the information below.
Product Recalls
Under Part 6 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) the Australian
Pesticides and Veterinary Medicines Authority (APVMA) may initiate the recall of an agvet product. The recall of an agvet
product may be necessary for a variety of reasons:
It is not registered with the APVMA.
Safety concerns.
Lack of efficacy.
The constituents/concentration/composition differ from those registered for the product.
The label differs from those registered for the product.
The label does not comply with labelling codes.
In some circumstances, the APVMA may allow the manufacturer of an agvet product to commence and lead the recall of
an agvet product (a voluntary or manufacturer-led recall). The APVMA’s decision to allow this is based on evidence and
the risk/s associated with the reason for the product recall.
If the APVMA thinks it necessary a compulsory recall may be instigated. It is important to remember that the APVMA
retains sole discretion as to the conduct of recalls.
Publication of recalls
It is APVMA policy to publish a short description for each product recall on our website. As part of responsible product
stewardship, the APVMA encourages you to publish a notification of recall on your website or have an appropriate
communication strategy in place.
Responsibility to notify the APVMA
Under section 161 of the Agvet Code if the holder of the registration for an agvet product becomes aware of information
which:
• contradicts information registered for an agvet product; or
• shows that the agvet product may not meet the safety, trade or efficacy criteria.
The holder must, as soon as they become aware of the information, give that information to the APVMA. It is an offence
not to do so.
Responsibility to notify the Australian Competition and Consumer Commission
Depending on the nature of the recall you may have an obligation to notify the Australian Competition and Consumer
Commission (ACCC). Further information can be found on the Product Safety Australia website.
Page 2: Notification of potential or actual recall of an agricultural or veterinary chemical product
Personal information collection notice
Your personal information is protected by law, including the Privacy Act 1988 and the Australian Privacy
Principles (APPs).
Your personal information is collected for the purpose of providing reports to the APVMA about potential or actual
recall events. Without this information, the APVMA may be unable to assess whether a recall is necessary. All
reports are retained by the APVMA electronically and/or in hard copy.
The APVMA publishes information about product recalls. This may include publication of personal information if
product recall notices are issued to an individual.
The APVMA may disclose your notification to Australian Commonwealth, State or Territory government agencies,
the registrant of the product(s), or any other relevant third party (for example medical practitioners or agronomists)
contracted to provide advice or comments to the APVMA. These entities must not use this information for any
other purpose. Personal information will only be disclosed to others where required by, or authorised under a law.
The APVMA is unlikely to disclose personal information to overseas recipients.
The APVMA’s Privacy Policy contains further information about how an individual may access or amend personal
information held by the APVMA, or make a complaint about the APVMA’s handling of personal information.
Page 3: Notification of potential or actual recall of an agricultural or veterinary chemical product
False or misleading information or documents
The provision of false or misleading information when completing this notification is an offence under section 146 of the
Agvet Code and section 137.1 of the Criminal Code Act 1995.
I declare that:
I have read and understood the information on this page.
The information contained in, and accompanying this notification is complete and correct.
I am authorised to submit this notification on behalf of the organisation listed below.
I understand that:
Giving false or misleading information is a serious offence and may lead to legal prosecution.
Signed:
Your name:
Your title/position:
Organisation represented:
Date:
Do not send products, containers or chemicals to the APVMA
Please attach any labels, advertising material, photographs or photocopies relating to the product/s of concern but do
not send product containers, chemicals or product samples to the APVMA as these may present a health and
safety risk.
Please send this notification with any supporting information to:
E-mail: recalls@apvma.gov.au
or
Att: Recalls Coordinator
Compliance and Monitoring
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262, Sydney NSW 2001
Notification of potential or actual recall of an agricultural or veterinary chemical
product
Your name
Your title/position
Organisation represented
Street address
Contact number
Contact email
Part 1: Product details
Product name
Registration status
Registered with the APVMA
Unregistered
Permit
Registration being reconsidered by the APVMA
Excluded from registration Other
APVMA product number
Page 4: Notification of potential or actual recall of an agricultural or veterinary chemical product
Active constituent(s)
Constituents differ from product registration
Poisons Schedule
Batch details
Please complete the batch reconciliation section on page 9 of this form for each batch to be recalled.
Alternately, you may attach reports or documents which provide the information required.
Part 2: Recall details
Reason for recall
Other
Unregistered product
Label issue
Composition/purity differs from product registration
Concentration differs from product registration
Description of reason for recall
Page 5: Notification of potential or actual recall of an agricultural or veterinary chemical product
Details of any associated adverse experiences
Page 6: Notification of potential or actual recall of an agricultural or veterinary chemical product
Risk to
Humans International trade Animals
Environment Other
Description of risks
Medium
Low
Self-assessment of risk
High
Proposed level of recall
Manufacturer
Wholesaler
Retailer End-users
Distribution of affected product
NSW Vic.
Qld SA WA
Tas.
International
Date the issue was identified
Details of how the issue was identified
Contact with other regulators
ACCC
State/territory
International
Other
If other was selected, please list other regulators
NT
ACT
Page 7: Notification of potential or actual recall of an agricultural or veterinary chemical product
Part 3: Recall plan
Actions taken to date
Communication plans
Notification of recall published on company website
Yes
No
Testing/investigation results
Page 8: Notification of potential or actual recall of an agricultural or veterinary chemical product
Estimated completion date
Plans for re-supply
Page 9: Notification of potential or actual recall of an agricultural or veterinary chemical product
Batch reconciliation
Batch
number
Date
released for
supply
Pack/unit
size
Batch expiry
date
Site of manufacture
No. units
manufactured
No. units
warehoused
No. units
distributed
to
wholesalers
No. units
distributed
to retailers
No. units
distributed
to
consumers
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Completed 22 November 2020

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