Volume 1
Background
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Volume 1 sets out the legal
background to the to the National Registration Scheme. Volume 1 also
gives information on how to make an application to the APVMA and the
how the APVMA manages the registration process.
General
- Introduction to MORAG MORAG
is the APVMA's Manual of Requirements and Guidelines.
- Application
procedures Under the Agricultural and Veterinary Chemicals
Code Act 1994 (available
here)
the Australian Government, through the APVMA, regulates the
manufacture, supply and sale of agricultural and veterinary (agvet)
chemical products in Australia.
Legal
- Legal background The
majority of primary producers rely on the supply of pesticides and
veterinary medicines to protect their crops and livestock from pests
and disease.
- Legislative
instrument 1 This Instrument is the Agricultural and
Veterinary Chemicals Code
Instrument No. 1 (Application Fees) 2005.
- Legislative
instrument 2 This Instrument is the Agricultural and
Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees)
2005.
Volume 2
Application categories
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Volume
2 describes the 25 different application categories so that applicants
can select the correct application category for their application.
General
Product registration
- Category 1 Approval
of a new active constituent contained in a chemical product,
registration of the associated chemical product and approval of the
product label.
- Category 2 Approval of a
new active constituent and registration of an associated chemical
product: Modular assessment.
- Category 3 Registration
of a new chemical product with an approved active constituent where no
registered chemical product contains the active constituent.
- Category 4 Registration
of a new chemical product with an approved active constituent, for use
on a major food crop.
- Category 5 Registration
of a new chemical product which is similar to a registered chemical
product.
- Category 6 Registration
of a new chemical product that is closely similar to a registered
chemical product: Chemistry and manufacture data required.
- Category 7 Registration
of a new chemical product that is closely similar to a registered
chemical product: Chemistry and manufacture data not required.
- Category 8 Repack of a
registered chemical product.
- Category 9 Listed
registration of a chemical product.
- Category 10 Registration
of a new chemical product: Modular assessment.
Variation
- Category 11 Extension
of use to include a new major food crop.
- Category 12 Minor,
non-technical variation to label and/or product details.
- Category 13 Minor,
non-technical variation to label and/or product details, required by
the APVMA.
- Categ ory 14 Variation
to a registered chemical product or approved label: Modular assessment.
Active constituent
- Category 15 Approval of
a new active constituent: Comprehensive assessment.
- Category 16 Approval
of a new active constituent: Limited toxicology assessment.
- Category 17 Approval of
a new active constituent: Toxicology assessment not required.
- Category 18 Variation
to particulars or conditions of an approved active constituent.
Permit
- Category 19 Application
for a permit to possess or supply for export an unapproved active
constituent or unregistered chemical product.
- Category 20 Application
for a permit where a previous assessment remains valid and no data of a
technical nature are required.
- Category 21 Application
for a minor use permit.
- Category 22 Application
for an emergency use permit.
- Category 23 Application
for a research permit or application for other permit type.
Other applications
- Category 24 Registration
of a chemical product or approval of an active constituent requiring
technical assessment and not covered by Categories 1-8, 10, or 15-17.
- Category 25 Assessment
of a trial protocol or application requiring technical assessment and
not covered by any other category.
Volume 3
Data
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Volume
3 gives details of the requirements and guidelines for each of the 10
data parts which might apply to different types of applications.
Outline
- Module
levels for modular categories allow an applicant to determine what data packages are required for each module required for assessment of an application which fits into a modular application category.
Data parts
Volume 4
Guidelines
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Volume 4 sets out guidelines for applications to register specific
types of products.
Volume 5
Labeling
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Volume
5 contains the Ag Labelling Code which sets out requirements and best
practice for product labels. Volume 5 also describes how the APVMA
approves labels which will be attached to registered products.
