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Part 1 – Application Overview

1.   PURPOSE OF THE APPLICATION OVERVIEW

Part 1 of an application dossier includes the combined Application Form and Overview. The purpose of the Overview section of the combined document is to provide a brief outline of the application. The Overview may contain other general information on the product, and a summary of all data in the application. The Overview is intended to lead reviewers through a submission.

An Application Overview must be included with the majority, but not all application categories. Detailed information is provided in the specific category chapters in Volume 2, Category requirements and guidelines.

Some parts of the Overview may not be applicable for new products based on existing active constituents and for variations to existing products. If an applicant considers that certain information is not required, a statement to that effect must be provided under the appropriate heading, together with the reasons (scientific argument) for not including it. Each such request will be considered on its merits.

Information provided in the Overview need not be repeated elsewhere in a submission. If the requirements of one of the application categories state that information or data should be presented in another part of the same submission, this may be simply done by reference to the information provided in the Overview.

If a future application is made to vary the registration of a product, applicants must complete an Application Form and Overview which gives full details of all variations. However, for product details that remain unchanged, applicants may refer to the date of the original application for registration of the product or the date when other variations were last approved by the APVMA.

2.   REQUIREMENTS

2.1.   Length of the Application Overview

The length of the Application Overview will vary depending on the nature and category of the application. As a guide, the Overview should be less than 20 pages.

2.2.   Presentation of the Application Overview

All pages of the application must be numbered. Separators with tabs may be used to identify attachments. The document must be unbound.

If an application contains data in a format that is inconsistent with APVMA Data Parts 2–10 (eg data submitted to an overseas authority), a table of contents must be provided for each data part, cross-referencing with APVMA Data Parts 2–10. The cross-reference table of contents must be included as an attachment to the Application Overview.

Further details on how to format data for submission of an application may be found in Volume 1, ‘Procedures for applications’.

2.3.   Content

The following headings are sub-parts of Part 1. Applicants must retain the sub-part numbering system because the heading numbers correlate to the number of the other data Parts.

1.1.  Introductory Information

1. Completed Application Form
2. Executive summary of the application
3. Reference product/s
4. Quantity likely to be used in first 2 years of registration
5. Registration status overseas for this and related formulations
6. Related submissions before the APVMA
7. Indicate whether the data presented with this application contradicts or changes the conclusions made from data provided previously.

1.2.  Chemistry and Manufacture

Declaration whether a separate Part 2 is included.

If a separate Part 2 is not included, scientific argument for not submitting data must be provided.

Briefly summarise any stability studies that have been submitted in Part 2.

Insert/attach batch release and expiry specifications for the product.

1.3.  Toxicology

Declaration whether a separate Part 3 is included.

If a separate Part 3 is not included, scientific argument for not submitting data must be provided.

Briefly summarise any toxicology studies that have been submitted in Part 3.

1.4.  Metabolism & Kinetics

Declaration whether a separate Part 4 is included.

If a separate Part 4 is not included, scientific argument for not submitting data must be provided.

Briefly summarise any metabolism and kinetics studies that have been submitted in Part 4.

1.5.  Residues and trade considerations (food crops only)

Declaration whether a separate Part 5 is included.

If a separate Part 5 is not included, scientific argument for not submitting data must be provided.

If a Part 5 dossier has been provided, insert here the summary section of the residues studies (Part 5A) and any trade data (Part 5B).

1.6.  Occupational Health and Safety

Declaration whether a separate Part 6 is included.

If a separate Part 6 is not included, scientific argument for not submitting data must be provided.

Briefly summarise any occupational health and safety studies that have been submitted in Part 6.

1.7.  Environmental Safety

Declaration whether a separate Part 7 is included.

If a separate Part 7 is not included, scientific argument for not submitting data must be provided.

Briefly summarise any environmental studies that have been submitted in Part 7.

1.8.  Target Species Efficacy and Safety

Declaration whether a separate Part 8 is included.

If a separate Part 8 is not included, scientific argument for not submitting data must be provided.

If a Part 8 dossier has been provided, insert here the summary section of the efficacy and safety studies.

1.9.  Other Trade Aspects

This Part must include a summary of the data/argument that use of the product will not unduly prejudice trade for concerns other than food residues concerns. Other types of concerns are:

• residues in fibre crops
• disease outbreaks from products containing live organisms
• interference with disease diagnostic programs from vaccine products, and
• market resistance of overseas consumers, for example with GMOs.

Declaration whether a separate Part 9 is included.

If a separate Part 9 is not included, scientific argument for not submitting data must be provided.

1.10.  Special Data

Where a product so requires that its registration by the APVMA is contingent upon advice from the Office of the Gene Technology Regulator (OGTR), or an import permit is required to be issued by the Australian Quarantine and Inspection Service (AQIS), the relevant documentation should be referred to in Part 1.10 and a copy attached.

Declaration whether a separate Part 10 is included.

If a separate Part 10 is not included, scientific argument for not submitting data must be provided.

2.4.   Attachments

Attachments, where applicable, should be identified and attached to the Application Overview. Attachments may include:

• Draft copies of the product label
• Copy of the current approved label with changes identified (for variations)
• Data Protection: Data List and Consent-for-use letter
• Letter of authority for an approved person
• OGTR approval documents
• Table of contents for each data part (for data in overseas format) cross-referencing with APVMA Data Parts 2–10.

3.   GUIDELINES

1.1 (a)  Application Form

See the explanatory notes provided with the Application Form.

1.1 (b)  Executive summary

The Executive summary of the application should include the reasons for the application. For a new product this will state whether the product contains a new active constituent and include a detailed scientific argument for registration of the product and outlining the importance, prevalence and (if necessary) the regional distribution of the pest/problem the product is intended to control, plus the economic and/or technical advantages of the product.

For variations to a registered product, the Executive Summary should specify all proposed changes.

1.1 (c)  Reference product(s)

Indicate the name and product number of any reference product(s). If there is no reference product, write ‘Not Applicable’.

1.1 (d)  Quantity to be used in the first 2 years after registration

An estimate of the quantity of active constituent expected to be manufactured or imported during the first 2 years must be provided.

The basis for the estimate should be provided together with an indication of whether the product is expected to replace existing registered product in the marketplace. If the application is for variation to a registered product, write ‘Not Applicable’ in this section.

1.1 (e)  Registration status overseas

The application must state whether there are any known current or previous applications or approvals in other countries for products containing the same active constituent. Where the product has been the subject of evaluation previously, full details of the outcome must be provided. If any data in the submission have been rejected by an overseas or Australian regulatory body, the applicant must identify this and submit scientific argument against the rejection.

The application must provide full details of the overseas-approved use pattern (host species, claims, directions for use and withholding periods), including any restrictions of use.

Where available, overseas evaluation reports should be provided in the relevant Parts of the submission.

A list of other relevant approvals and description of their relationship to the current application, eg approvals for other formulations containing the same active constituents should be provided where it relates to the current application.

1.1 (f)  Related submissions before the APVMA

The applicant must provide the status of any previous or current applications that the applicant has made for any other product containing this active constituent.

1.1 (g)  Data contradicting or changing conclusions from previous applications

Indicate whether the data or conclusions presented in the current application contradict data or conclusions in previous applications, including a full explanation of how the new data can be justified.

Draft label Attachment

Applicants should consult Volume 5 for specific information on labelling and the label approval process.

All components of the proposed product label (primary pack, immediate container, leaflet) must be included in the Application Overview. Applicants are advised to initially submit a draft label in text form (TXL). For TXLs, all pack sizes may be consolidated on a single label.

Ten copies of the marketed product label (MPL) or a printers proof label (PPL) for each pack size will be required before the application can be finalised. If applicants initially submit a TXL for assessment, the APVMA will inform the applicant when to submit the ten MPLs or PPLs in order to finalise the application.

Information about the type of draft label to be submitted is described in the instructions for the individual categories in Vet MORAG Volume 2. Labels should be page numbered and version controlled, showing the date of the copy.

For variations to existing approved labels, applicants must provide a copy of the currently approved label showing all deletions struck out and a copy of the proposed new label showing all additions underlined. All changes (including changes to formulation details) should be highlighted to make them obvious.

The claims to be made on the label are the only claims which may be used in sales promotion. It is therefore in the applicant's interest to make sure that claims are clearly stated and substantiated by data/argument in the detailed application.

4.   REFERENCES

The common name for the pest, weed or disease, based on the appropriate current references listed below should be used:

Insects:

• Australian Insect Common Names www.ento.csiro.au/aicn
• CSIRO Handbook of Australian Insect Names 1993. ISBN 064305510X

Weeds:

• Shepherd RCH, RG Richardson & FJ Richardson (2001) Plants of Importance to Australia, A Checklist. ISBN 0958743959
• Lazarides M, K Cowley & P Hohnen (1997) CSIRO Handbook of Australian Weeds. ISBN 0643059814
• Lazarides M & B Hince (1993) CSIRO Handbook of Economic Plants of Australia. ISBN 0643052402

Diseases:

No current national reference exists, however checklists of recorded plant diseases are available from State agricultural authorities. Other useful references include current editions of:

• Ornamental Plants. Pests, Diseases and Disorders. DPI Queensland. ISBN 0724259678.
• Cereal Leaf and Stem Diseases. GRDC. ISBN 0642182418.
• Diseases of Vegetable Crops. DPI Queensland. ISBN 0724253726.
• Diseases of Fruit Crops. DPI Queensland. ISBN 0724239812.

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