For Official Use Only
Item 22
Application for a permit where the use of the chemical product
or active constituent is proposed to be an emergency use
Important Note: On 1 July 2014 the APVMA moved to an electronic application system. Portal users should submit emergency permit
applications through the electronic application system. This form should only be completed by persons who do not have current access to
the online portal.
1. Purpose of the Application
a). This application is for:
☐ a new emergency use permit
☐ an extension of the duration of an emergency permit which requires technical assessment (this does not include
state extension)
Permit No:
Description:
Expiry date:
b). The permit is for:
☐ Agricultural chemical product
☐ Veterinary chemical product
c). Product and active constituent details:
☐
This application involves a Registered Product
☐
This application involves an Unregistered Product
Product name:
☐ Include all similar registered products in permit
Active constituent name
Active constituent concentration
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2. Applicant Contact Details
Full name of applicant:
Name of contact person:
Position/title:
ACN / Overseas equivalent number:
Street address:
Postal address:
Email:
Telephone:
Facsimile:
Telephone:
Facsimile:
3. Authorised Agent Details
☐
Authorised Agent
☐
No Agent
Full Name of agent (can be a company):
Name of contact person in the company:
Position/title:
Postal address:
Email:
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4. Fit for Purpose Declaration
☐ I declare that in accordance with paragraph 112(4)(b) of the Agvet Code, neither the:
•
the applicant for the permit (the Applicant); or
•
any person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the
Applicant's affairs; or
•
if the Applicant is a body corporate, a person who is a major interest holder of the body corporate
has, within the 10 years immediately before this application:
•
•
•
•
•
•
•
•
•
been convicted of an offence against an agvet law; or
been convicted of an offence against a law of this or another jurisdiction relating to chemical products; or
been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving
fraud or dishonesty; or
been proven guilty of an offence include above where the court has not recorded a conviction; or
been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision; or
been ordered to pay a pecuniary penalty for the contravention of another law of this or another jurisdiction
relating to chemical products; or
been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
held a permit that was cancelled under subsections 119(2) or section 119B of the Agvet Code or under a
corresponding provision of the Agvet Code of another jurisdiction; or
been a manager, or major interest holder, of a body corporate in respect of which any of the matters, noted
above, applied in that 10 year period, if the conduct resulting in that matter occurred when the person was a
manager or major interest holder of the body corporate.
☐ cannot make the above declaration in accordance with paragraph 112(4)(b) of the Agvet Code because:
request that the APVMA consider the following special circumstances in this case:
☐ cannot make the above declaration in accordance with paragraph 112(4)(b) of the Agvet Code
5. Correspondence
Correspondence about this application is to be addressed to:
☐ Applicant
☐ Authorised Agent
☐ Email correspondance is acceptable
6. Declaration
☐ I have submitted the template(s) for the approved label.
☐ I have submitted all related information online.
☐
I have more information to be posted to APVMA within 7 days.
☐
I declare that the information provided with this application is complete and correct.
Signature: ........................................
Date: .... / .... / ....
Giving false or misleading information is a serious offence and may lead to prosecution for an offence against the Agricultural
and Veterinary Chemicals Code.
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7. General Details
Proposed duration of permit.
First date of proposed use
Annual timing of use
(ie. from Sep - Mar or ongoing throughout year)
Proposed permit duration
(ie. 1, 2, 5, 10 years or ongoing)
Location of proposed use.
Locations:
☐ All States ACT
☐ NSW
☐ NT
☐ QLD
☐ SA
☐ TAS
☐ VIC
☐ WA
Specific locations:
Persons to be covered by the permit.
Persons
☐ 'All persons' (includes everyone - ie no restrictions)
☐ A specific group
☐ One or more nominated individuals
Details of persons
Scale of use.
Estimated or proposed scale of use:
(area, tonnage, number of trees, number of
animals, number of doses etc.)
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8. Proposed Use (Agricultural)
Note: For multiple crops and/or situations, copy table
Target crop or situation
☐ Crop
☐ Situation
Is the crop grown in
☐ field, ☐ undercover (protected) or ☐ both.
Target disease, pest or purpose
(include common and scientific
names)
Common Name
Application rate, spray volume
and addition of wetters (or other
proposed additives/mixtures)
Application rate
Spray volume
Addition of wetter
(eg. 100mL or 100g product /
100L and/or 1L or 1kg / ha)
(eg. 500L/ha)
(eg. plus 200mL/100L – please specify
wetter)
Timing of application/growth
stage (eg. apply at budburst,
blossom bloom etc.)
Maximum number of applications
and interval between
applications.
Scientific name
Maximum number of applications per
crop, season or year (please specify)
Minimum re-treatment interval (days)
between consecutive applications
Proposed withholding periods
(food and/or livestock feed crops
only)
Harvest - number of days or weeks
between last application and harvest
(or Nil)
Grazing & Cutting for Livestock
(or Nil)
Application method & equipment
Application method
(eg. foliar, drench, in-furrow, aerial)
Application equipment
(eg. knapsack, air-blast sprayer,
boomspray)
Any special precautions/ critical
use comments
Is the chemical product intended to be applied to a genetically modified crop?
☐ Yes ☐ No
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8. Proposed Use (Veterinary)
Note: For multiple crops and/or situations, copy table
Target animal (1)
Target disease, pest
or purpose
Common name
Scientific name
Dose rate
Timing and frequency of doses
Route of administration
Maximum number of doses per animal
Minimum interval between doses
The equipment to apply the product
Period between last dose and slaughter
or milking of the animal, the collection
of eggs, or the harvesting of wool or
fibre, if relevant
Any special precautions / critical use
comments
Recognised GMP evidence for
overseas sites and/or APVMA licence
number
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9. Justification for the proposed use
a). Provide reasons as to how the proposed use qualifies as an emergency use:
b). Are any products currently registered or approved for the proposed use?
☐ Yes
Provide justification for why the proposed use should be considered instead of the currently registered
products:
☐ No
c). Has an application been made to register the product?
☐ Yes
Give the status of this and any other related applications that you have made to the APVMA.
Product/Application No
Product Name
Application Status
☐ No
Provide the reasons as to why no application has been made:
If you are seeking an emergency permit in relation to a veterinary chemical product, have you sought support
from the Chief Veterinary Officers, States, Animal Health Australia, and other peak bodies?
☐ Yes ☐ No
If Yes please attach their response:
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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10. Formulation Details (Unregistered products only)
FULL formulation details - every constituent must be listed. Indicate how the formulation details are supplied:
☐ I provide the full details below.
☐ The manufacturer(s) will provide details to the APVMA separately.
Provide the full formulation details of the product. For details on required information, refer to Chemistry and
manufacture data parts in The Regulatory Guidelines.
Formulation details submitted on this page must only be disclosed to:
☐ Applicant/Holder
☐ Manufacturer/Formulator
☐ Nominated Agent
☐ Other
Constituent Name
CAS number
If applicable)
Constituent
standard
Concentration
Purpose in formulation
(a) Active constituent(s)
(b) Other constituent(s)
Total weight/weight (solids, semi-solids) or weight/volume (liquids)
Specific gravity (SG) (liquids only)
Formulation type: (eg pour-on, tablet, powder, paste, aerosol,
wettable powder, emulsifiable concentrate etc)
Does the product contain a genetically modified organism (GMO) or any product
derived from a GMO?
☐ Yes
☐ No
Does the product contain imported ingredients of biological origin?
☐ Yes
☐ No
If yes, is the Agriculture Biosecurity Import Permit or completed Agriculture
Biosecurity Import Permit application form attached?
☐ Yes
☐ No
Does the product/active constituent contain any material intentionally engineered to be
< 100 nm in one or more dimensions?
☐ Yes
☐ No
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10. Formulation Details (Unregistered Immunological products)
FULL formulation details - every constituent must be listed. Indicate how the formulation details are supplied:
☐
I provide the full details below.
☐ The manufacturer(s) will provide details to the APVMA separately.
Provide the full formulation details of the product. For details on required information, refer to Chemistry and
manufacture data parts in The Regulatory Guidelines.
Formulation details submitted on this page must only be disclosed to:
☐ Applicant/Holder
☐ Manufacturer/Formulator
☐ Nominated Agent
☐ Other
Constituent Name
Minimum
release titre
Maximum
release titre
End of shelf
life titre
Purpose in formulation
(a) Immunobiological active constituent(s)
Constituent Name
Constituent
CAS number
Concentration
standard
Purpose in
formulation
Constituent Name
a) Non-immunobiological active constituent(s)
(b) Other constituent(s)
Total weight/weight (solids, semi-solids) or weight/volume (liquids)
Specific gravity (SG) (liquids only)
Formulation type: (eg pour-on, tablet, powder, paste, aerosol,
wettable powder, emulsifiable concentrate etc)
Does the product contain any ingredients with a risk of transmitting agents of animal
spongiform encephalopathies?
☐ Yes
☐ No
Does the product contain a genetically modified organism (GMO) or any product
derived from a GMO?
☐ Yes
☐ No
Does the product contain imported ingredients of biological origin?
☐ Yes
☐ No
Does the product contain any material intentionally engineered to be < 100 nm in one or ☐ Yes
more dimensions?
☐ No
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11. Active Constituent Details (Unapproved actives)
Minimum purity or pharmacopoeial standard:
IUPAC Name:
Common Names:
CAS Number:
Is the active constituent a genetically modified organism (GMO) or manufactured using
genetically modified (GM) materials?
☐ Yes
☐ No
Does the active constituent contain any material intentionally engineered to be < 100
nm in one or more dimensions?
☐ Yes
☐ No
12. Manufacturer Details (Unregistered Vet Products)
Note for veterinary products: - The manufacturers nominated must be licensed to manufacture the product for
which this registration application applies. Include the name and street address of all facilities involved in any step of
manufacture, including packaging and labelling, contractors and analytical laboratories where applicable.
Please include details of ALL sites of manufacture for this product, including current approved sites and proposed
sites.
SITE 1:
Manufacturer:
☐ Australian site of manufacture
☐ Overseas site of manufacture
☐ Exempt Product (Vet only)
Full name of company:
ABN/ACN or overseas equivalent:
APVMA licence number:
Street Address:
Category of licence:
☐ Sterile and/or immunobiological products
☐ Non sterile veterinary preparations except Categories 3, 4 and 6
☐ Ectoparasiticides [for external application]
☐ Premixes/Supplements
☐ Single Step
Product Type / Dosage Form:
Steps of manufacture:
Flow diagram:
Does this site perform release for
supply?
☐ Yes
☐ No
13. Manufacturers of Active Constituents (Unregistered Immunological)
Active Constituent 1:
Active constituent common name:
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Reference (EP, BP, USP, other specification):
Source/history of isolation:
Identity (strain, genus, species and serotype/biotype):
Unique identifier/descriptor (gene/phage type, molecular weight
extract etc):
Master seed code and passage level:
Working seed code and passage level:
14. Active Constituent Manufacturer Details (Unregistered Ag products)
Manufacturer's business name
ACN or overseas
equivalent
Manufacturer's
business address
Manufacturing site name
and physical address
15. Overseas registration
Are you aware if this pattern is registered overseas?
☐ Yes
☐ No
If Yes please name the country (or countries) and provide a copy of label and assessment report, if available.
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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16. Registered Product Holder/Manufacturer support of product in Australia
Have you contacted the Registered Product Holder/Manufacturer for support of this use?
☐ Yes
☐ No
Do they have any data that would support this application
☐ Yes
☐ No
Attach any appropriate documents
17. Importation Details
☐ a separate application for a concent to import has been lodged
☐ a separate application for a concent to import will be lodged
☐ not applicable
18. Product Supplier Details
The supplier will be the:
☐ Permit applicant
☐
Other
Name of supplier:
ACN details:
Address of Supplier:
19. Container and Net Content Details
Proposed net content(s)
Brief description of the packaging and
closure material, including that which is
in direct contact with the product
Method of label attachment
Provide details of product presentation (eg single glass bottle inside individual cardboard carton with enclosed leaflet).
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20. Storage Stability Details
For veterinary chemical products and date controlled
agricultural chemical products only.
Non-date controlled agricultural chemical products
are expected to demonstrate acceptable storage
stability of at least 2 years under normal conditions.
The proposed shelf life from the date of manufacture:
The proposed storage conditions: (eg below 30°, room
temperature; normal conditions of humidity/ light)
Have data to support the storage stability of the product been
provided with this application?
If no stability data have been submitted, ensure that a
suitable scientific argument has been provided in the
chemistry section of the Application Overview.
For veterinary chemical products in multiple
dose containers:
☐ Yes
☐ No
☐ Yes
☐ No
Has in-use stability data to support an in-use shelf
life been provided with this application?
21. Executive Summary
Describe the purpose of the application.
22. Chemistry and Manufacture
Have you provided a separate Chemistry and Manufacture data package:
☐ No, the proposed product is registered and is supplied in an approved container
☐ No, justify why a separate Chemistry and Manufacture data package has not been provided:
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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23(a). Toxicology
Have you provided a separate Toxicology data package:
☐
No, the proposed product is registered or contains a currently approved active constituent
☐
No, justify why a separate Toxicology data package has not been provided
☐
This application involves a new active/product never previously considered
☐ This application involves a new active/product never previously approved in Australia for non-food uses only
☐ This application involves a previously considered active/product for extension into food where food uses were
not previously considered
☐ This application involves a previously considered active/product where formulation changes affect label hazard
statements or other minor human health assessment
☐
Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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23(b). Poisons Scheduling
Have you provided a separate Scheduling data package:
☐
No, the proposed label is consistent with the current Poisons schedule and the use pattern will not result in
additional risk to users
☐ No, justify why this data package has not been provided
☐
Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
Specify the following:
☐
I do not wish to propose a schedule (outcome)
☐
Schedule as proposed below
Nominate poison schedule:
☐ Schedule 4 (Prescription Only Medicine OR Prescription Animal
☐ Remedy)
Schedule 5 (Caution)
☐ Schedule 6 (Poison)
☐ Schedule 7 (Dangerous Poison)
☐ Schedule 8 (Controlled Drug)
☐ Schedule 9 (Prohibited Substance)
☐ Poisons Standard Appendix B - substance considered not to require control by scheduling
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24. Metabolism and Kinetics
Have you provided a separate Metabolism and Kinetics data package:
☐ No
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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25(a). Residues Safety Criteria
Have you provided a separate Residues data package:
☐
☐
No, food, processed commodities, by-products or animal feed will not be available for consumption by humans or
animals
No, food, processed commodities, by-products or animal feed may be available for consumption, however,
current Maximum Residue Limits (MRLs) are appropriate or the use is exempt from the requirements of an
MRL
☐
No, justify why a separate Residues data package has not been provided:
☐ Yes
☐ This application involves a new active constituent for use in food or extension of a previously approved active
into food
☐ This application involves an existing active constituent for use in a new food animal, a major or more than 6
minor food producing species
☐ This application involves less than 6 minor food producing species
Data item number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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25(b). Trade Criteria
Have you provided a separate Trade data package:
☐ No, food or stockfeed commodities derived from treated crops, animals or other situations will not be made
available for export or sold into a market where export may occur
☐ No, justify why a separate Trade data package has not been provided:
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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26. Work Health and Safety Criteria
Have you provided a separate Work Health and Safety data package:
☐ No, the product is registered or the proposed use pattern will not change the currently approved user safety/reentry or handling directions
☐ No, justify why a separate Work Health and Safety data package has not been provided:
☐ This application involves persons generally use of a new active/product never previously considered
☐ This application involves currently approved products which require assessment of user safety/re-entry or
handling directions associated with new proposed uses
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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27. Environmental Safety Criteria
Have you provided a separate Environmental Safety data package:
☐ No, the proposed use pattern is equivalent to currently registered products in terms of risks to the environment
☐ No, justify why a separate Environmental Safety data package has not been provided:
☐ This application involves a new active or combination of approved actives or use in a situation that will increase
environmental exposure where extensive consideration of fate, effects, environmental monitoring data or exposure
modelling is required
☐ This application involves use of an approved active in a situation that will increase environmental exposure
where some consideration of fate effects, environmental monitoring data or exposure modelling is required
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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28. Target Animal/Crop Safety
Have you provided a separate Target Animal/Crop Safety data package:
☐ No
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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29. Efficacy Criteria
Have you provided a separate Efficacy data package:
☐ No, the proposed use pattern is exempt from efficacy requirements
☐ No, justify why a separate Efficacy data package has not been provided:
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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30. Non-food Trade Aspects
Have you provided a separate non-food trade data package:
☐ No, non-food commodities derived from treated crops, animals or other situations will not be made available for
export or sold into a market where export may occur.
☐ No, justify why a separate non-food trade data package has not been provided:
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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31. Special Data
Have you provided a separate special data package, relating to antibiotic resistance, genetically-modified organisms,
GMP licencing requirements or other special cases as required by data requirements:
☐ No, this section is not applicable to the current application
☐ No, justify why a separate special data package has not been provided:
☐ This application involves a new antibiotic (not for small scale research) for use in new species or other special
data submission requiring extensive consideration
☐ This application involves small scale research on an antibiotic or variation to existing antibiotic use or other
special data submission requiring reduced consideration
☐ This application involves Genetically Modified Organisms (GMO), nanotech or GMP licensing data requiring
further consideration and consultation
☐ Yes
Data item Number:
Reference No:
Type:
Sub-Type:
Study Date:
Authors:
Title:
Publication:
Authorising Party:
☐ Applicant
☐ Public Domain
☐ Other Party
☐ Previous Submission, Protected
☐ Previous Submission, Not Protected
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