Agricultural Manual of Requirements and Guidelines - Ag MORAG

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General requirements for lodging an application

General requirements for making an application for:

  • approval, or variation of approval, of active constituents
  • registration, or variation of registration, of chemical products
  • approval, or variation of approval, of labels

1.   INTRODUCTION

Under the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) the Australian Government, through the APVMA, regulates the manufacture, supply and sale of agricultural and veterinary (agvet) chemical products in Australia.

For a description of the legislation governing the regulation of these chemicals, see Chapter 2 of this volume, Legal background to the National Registration Scheme.

The APVMA has the responsibility to ensure that agvet chemicals registered for use in Australia are:

  • safe to the host, the user, the general public and the environment
  • efficacious - that is, they do the job they are supposed to do
  • suitably formulated and properly labelled
  • not unduly prejudicial to trade when used according to instructions.

The APVMA achieves these outcomes by:

  • evaluating active constituents, products and their labels
  • reviewing existing chemicals where potential risks to safety or performance have been identified
  • issuing permits for emergency uses, minor uses or for research purposes
  • issuing licences to manufacturers of veterinary chemical products
  • with assistance from the states and territories, conducting a national program of compliance and surveillance up to and including the point of retail sale.

This chapter outlines the procedures for applying to the APVMA for registration or approval of an agricultural or veterinary chemical or product. Detailed guidance on the category under which an application must be made, and data requirements for an application are set out in Volume 2: Category requirements and guidelines, and Volume 3: Data requirements and guidelines.Top

2.   TYPES OF REGISTRATION

There are three types of regulation for agvet chemical products, according to the level of risk posed by the products and the appropriate management framework. Apart from normal registration, two types of regulation known as ‘listed registration’ and ‘reserved from registration’ are available for agvet chemical products which are considered to pose a lower regulatory risk.

1.   Registered chemical products

These are products which are subject to the normal requirements of registration. These products are defined under s.4 and s.5 of the Agvet Code, ie agvet chemical products which:

  • destroy, repel or prevent infestation of plant pests
  • modify the physiology of plants
  • prevent, diagnose, cure or alleviate animal disease
  • modify the physiology of an animal.

2.   Listed registered chemical products

These are lower risk agvet chemical products which do not warrant the rigorous, individualised assessment process that applies to registered chemical products. These products can be given listed registration against a Standard, provided that:

  • the APVMA has submitted a Standard to the Minister declaring it is satisfied that the use of the product or class of products in accordance with the Standard would be safe, effective and not a trade risk
  • the Minister has approved the Standard that the APVMA proposes to apply to that product or class of products
  • the chemical or class of chemicals has subsequently been included in a Schedule of Listable Chemical Products in the Agvet Code Regulations.

3.   Reserved chemical products

Agricultural or veterinary chemical products or classes of products can be reserved from registration subject to Conditions, provided that:

  • the APVMA has submitted Conditions to the Minister declaring it is satisfied that the use of the product or class of products in accordance with the Conditions would be safe, effective and not a trade risk
  • the Minister has approved the Conditions that the APVMA proposes to apply to reservation of that chemical product
  • the chemical or class of chemicals has subsequently been included in a Schedule of Reserved Chemical Products in the Agvet Code Regulations.

This is a very simple system of regulating minimal risk products. Such products are agvet chemicals, but they are not registered and are not subject to the offence provisions of the Agvet Code which apply to the possession and supply of unregistered agvet products, provided they comply with the Conditions set out in the Regulations. In other words it is not an offence to possess and/or supply a reserved chemical product, even though it is not registered.

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3.   WHO CAN MAKE AN APPLICATION?

The applicant for:

  • approval of an active constituent for a proposed or existing chemical product
  • registration, or listed registration of a new agricultural or veterinary chemical product
  • approval of a label.

- may be an individual or a body corporate.

For an existing approval or an existing registration, the registrant or approval holder (‘interested person’) can submit further applications that relate to the approval or registration that they hold. The registrant or approval holder may apply to the APVMA to vary:

  • a label
  • relevant particulars or conditions of the approval or registration.

3.1.   Applicant/registrant details

The applicant is the individual or body corporate who/which will become the registrant or owner of the approved active constituent, registered new agvet chemical product or approved label.

The application form must contain the applicant’s full name, street and postal address. If the applicant is a body corporate the Australian Company Number (ACN) or overseas equivalent must be provided.

In all cases, the applicant must nominate a contact person and their position and title in case the APVMA must contact the applicant.

3.2.   Approved person

The approved person is the individual or body corporate resident in Australia who/that will take responsibility for the application to register the product or approve the active constituent or label. In relation to an application, the approved person is responsible for:

  • signing the application form
  • giving consent to the APVMA to alter the application form
  • giving extra information or varying information previously given to the APVMA
  • giving the APVMA written notice to withdraw the application.

If the approved person is an individual, they must reside in Australia. If the approved person is a body corporate, the body corporate must be incorporated in Australia.

In many cases, the applicant and the approved person are the same. However, the applicant can appoint a third party (an individual or body corporate outside their company) to act as the approved person for the purposes of the application. The applicant may also wish to appoint the same or a different approved person in relation to post-registration matters.

3.3.   Approved person declaration

If the approved person is a body corporate, the individual signing the application form must be authorised to sign on behalf of the body corporate. Authorisation of an individual to sign on behalf of a body corporate must be in writing and be signed by an appropriate representative from the body corporate such as the General Manager, Chief Executive Officer, Regulatory Affairs Manager or similar.

3.3.1.   An Australian applicant or registrant can appoint a different approved person

An Australian applicant or registrant can notify the APVMA in writing of the appointment of a different person residing in Australia or a body corporate incorporated in Australia to act as the approved person in relation to an application and/or to be the point of contact for the APVMA in relation to an application. In this case the APVMA will deal with the appointed approved person.

The Australian registrant can also decide to appoint a different approved person in relation to post-registration matters. In this case the APVMA will write to and issue notices related to post-registration matters, to the different approved person.

The Australian applicant or registrant can withdraw the appointment of an approved person at any time by writing to the APVMA, and can also vary the authority or responsibilities of an approved person. If an Australian applicant or registrant decides to vary the authority or responsibilities of an approved person, or decides appoint a different approved person, the applicant or registrant must send a letter to inform the APVMA of the changes, so that the APVMA can update its records.

3.3.2. Overseas applicants and registrants must appoint an Australian approved person

Overseas applicants and registrants must appoint an Australian person or body corporate as the approved person when lodging an application, varying an application, submitting new relevant information or withdrawing an application. Similarly, overseas applicants must appoint an Australian person or body corporate as the approved person to whom the APVMA should write in relation to the screening of an application, the notice of registration and/or approval or refusal of an application.

It is open to the overseas registrant, but not mandatory, to appoint an approved person in relation to post-registration matters such as cancellations, suspensions or reconsiderations of registrations or approval. If the overseas registrant elects not to appoint an approved person for these post-registration matters, the APVMA will write to and issue notices to the overseas registrant.

3.3.3.   Letter of authority

When an overseas applicant or registrant appoints a person residing in Australia, or a body corporate incorporated in Australia, to be an approved person, they must send a letter of authority to the APVMA. The letter of authority must specify which of the regulatory matters the authorised person is authorised to conduct. If the authorised person is authorised to conduct all regulatory matters, the letter of authority should state:

‘I appoint [NAME OF APPROVED PERSON] for the purposes of all regulatory matters associated with this application and for the purposes of all regulatory matters following registration and/or approval’

- or words to that effect.

If a registrant or applicant appoints a different approved person for any one or more of the regulatory matters, they must send the APVMA a separate letter for each different approved person.

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4.   REQUIREMENTS FOR MAKING AN APPLICATION

A complete application must:

  • include the appropriate and fully completed application form signed by an approved person
  • include all the information that the APVMA requires (see Volumes 2 and 3 of this manual, or the relevant Standard)
  • be accompanied by the appropriate fee.

An application will not be accepted by the APVMA and proceed to a full evaluation unless it is complete.

4.1.   Documentation which must be submitted with an application

An application can range from only a completed application form to a multi-volume dossier containing detailed scientific reports and scientifically-based arguments. As a minimum, an application must include the following documents and information:

Application Form and Application Overview

In many cases, an application will require an application overview. The application form and application overview (see Part 1 Application overview in Volume 3 ‘Data requirements and guidelines’) are combined into a single document. The application form relevant to each application type is available on the APVMA website.

The Application Form and Overview must contain the signature of the approved person. Any whiteout or corrections must be initialled. A single unbound copy of the combined document must be provided to the APVMA.

Formulation details of the proposed product

The applicant or approved person usually submits the complete formulation details of the proposed product with the application. However, if the applicant or approved person is obtaining the formulation from another source and does not have access to the information, the applicant or approved person must ensure that the formulator separately provides the full formulation details to the APVMA.

The provider of the formulation details must ensure that the information adequately identifies the application to which the information relates (ie reference the applicant’s name, the product name and product number if known).

If the formulation details are confidential commercial information (CCI) the formulator and applicant/approved person must clearly state this in the application. Unless otherwise advised, the APVMA will assume that a formulation provided directly by a formulator to the APVMA is information which is CCI to the formulator.

Fee

An application fee must be submitted with the application. The exact application fee is determined by the application category, or from the total modules if the application falls into a modular category. The application category or relevant modules can be determined from Volume 2 and Volume 3.

The APVMA prefers that applicants submit the full fee with the application. If an applicant is unsure of the full fee, the applicant may submit the fee of $535 for preliminary assessment (screening). The APVMA will request the balance of the fee after screening, when the APVMA has made a determination that the application can proceed to full evaluation, and under which category. The application cannot proceed to evaluation until the applicant has paid the full application fee.

If an applicant has submitted an excess amount, the APVMA will refund the excess amount.

The APVMA is able to accept payment only by cheque. Cheques should be made payable to the Australian Pesticides and Veterinary Medicines Authority.

Formulator’s declaration

If the proposed new product is a repack of a registered product, the application must be made under Category 8. A formulator’s declaration must be submitted, as detailed in Category 8 in Volume 2. The formulator’s declaration must be on the formulator’s company letterhead and must contain the name and the title of the person signing the declaration. If more than one formulator is involved in manufacture of a product, each formulator must provide a declaration covering the manufacturing steps they perform.

Label

Applicants must provide an electronic label (e-label) of the marketed product label (MPL) before the APVMA can finalise an application for registration, or variation to registration or label approval. Further details may be found in The label approval process in Volume 5.

Data

Each application category has different data requirements. Applications must include relevant data or scientific argument not to provide data.

The APVMA’s data requirements for each type of application are outlined in Volumes 2 and 3 of this manual.

When an application is first submitted to the APVMA, any accompanying data (data Parts 2 to 10) must be bound.

If an application requires submission of different data Parts (eg chemistry and efficacy and residues), each data Part must be submitted as a separate volume. Different data Parts must not be combined within the same bound volume.

Applicants should submit a single copy of each volume of bound data in the first instance. The APVMA will request further copies once the application has passed technical screening.

4.2.   Where to send an application

All applications must be in hard copy and mailed to:

Application Management and Enquiries
Australian Pesticides & Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

or delivered to:

Application Management and Enquiries
Australian Pesticides & Veterinary Medicines Authority
18 Wormald Street
SYMONSTON ACT 2609

All correspondence between the APVMA and an approved person must be dated and include:

  • the product name or the proposed product name
  • the APVMA file number and application number (if known)
  • the name, position and contact details of the person signing the correspondence.

4.3.   How an application can be altered

An approved person may authorise the APVMA to alter aspects of their application, by sending written authorisation.

An approved person may give the APVMA additional or different information at any time after they have submitted an application.

4.4.   How an applicant can withdraw their application

At any stage of an application, an applicant or approved person may give the APVMA advice that they wish to withdraw their application by sending written authorisation.

When an applicant voluntarily withdraws an application before the evaluation process has commenced, the APVMA will retain the $535 screening fee and refund the balance of the application fee to the applicant.

If the application has passed screening and evaluation has commenced, the APVMA may retain all or part of the fee.

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4.5.   How to format an application

Language

All applications and accompanying data submitted to the APVMA must be in English. If an applicant wishes to submit material in another language, they must supply an authorised English translation, and clearly identify it as such. The APVMA may request the original foreign language paper.

Confidential commercial information

APVMA staff are required to handle confidential commercial information (CCI) submitted by applicants. ‘Confidential commercial information’ is defined in the Agvet Code as:

Confidential commercial information, in relation to an application for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:

a trade secret relating to the constituent or product; or

any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or

any information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:

concerns the lawful commercial or financial affairs of a person, organisation or undertaking;

relates to the manufacture, distribution or supply of the constituent or product; and

if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner.

The Agvet Code provides certain protection to confidential data submitted to the APVMA. Applicants may include statements to the effect:

‘information and data submitted contain trade secrets’; or

‘contains commercial information which is the property of the applicant’; or

‘disclosure of the information or data to the APVMA is on a confidential basis’; or

‘no government agency is authorised to disclose the data and information without written permission from the applicant’

It is also open to an applicant to claim that the information is to be treated as ‘confidential commercial information’ for the purposes of the Agvet Code or when subject to any request for disclosure under the Freedom of Information Act. However, applicants should note that making a statement of this nature does not necessarily mean that the APVMA will be able to prevent such information from being released.

However, the APVMA will pay no attention to statements (however stated) to the effect that:

‘The information or data are supplied only for the purposes of enabling the APVMA to evaluate the application for approval/registration of a particular product the subject of the present application’;
- or:
‘The information or data are not to be used, either directly or indirectly, to approve or register another product without the prior written permission of the applicant’.

These types of confidentiality statements purport to establish a claim that is over and above the data protection provided by the Agvet Code.

Cover page for bound data

The cover page for bound data must contain certain information to enable evaluators and reviewers to easily identify and access data. Applicants must label the cover of each volume with the following information:

  • name of the applicant
  • common name of the active constituent and its approval number (if applicable)
  • trade name/distinguishing name of the product
  • APVMA file number (if known)
  • type of application or category
  • volume numbers and total number of volumes in the application
  • data Part number and a brief statement of the contents
  • date of application.

Table of contents

Data Parts that contain more than 10 pages of data must have a table of contents showing the page numbers. If a data Part consists of more than one volume, each volume must be clearly identified.

Presentation

All material submitted must be legible and printed on A4 paper. Applicants may print pages on both sides if legibility is not affected. Margins must be wide enough to enable the material to be read when bound and/or placed on file.

The material must be presented in a systematic order. If the entire data submission contains more than 10 pages of data, applicants must separate the different data Parts (eg the Chemistry data Part from the Toxicology Part).

If a section comprises a series of studies, a concise summary (abstract) must be provided at the front of each study. Within each section, similar studies must be grouped together to facilitate assessment (eg group all acute toxicology studies together). The full name of each study must be listed in the table of contents along with referenced species.

Photocopies and photographs

Applicants must ensure that all photocopies are legible with adequate margins on both edges of the page. The APVMA will return any unreadable, unclear or incomplete copies and ask the applicant to replace them.

Any photographs must be of a quality suitable for reproduction. Original prints are preferred. Photocopies of photographs will only be accepted if they are of good quality and clearly illustrate the subject.

References and testimonials

If specific references are cited in an application, applicants must include a legible copy of the whole article with the application. Applicants must indicate which part of the reference is applicable to the application. For generally accepted scientific information, full references will not usually be required. However, in some instances the APVMA may require a copy of a reference.

Testimonials and other forms of anecdotal evidence are generally not acceptable, and will normally be disregarded. However, a short summary (less than 250 words) may be provided.

Pagination

Applicants must number the pages of their application systematically so that evaluators and reviewers can easily and accurately locate data or application parts.

Pages may be sequentially numbered from start to finish or, if an application is in several volumes, sequentially numbered within each volume, eg:

Part 1:   Pages 1.1, 1.2, 1.3 and so on

Part 2:   Pages 2.1, 2.2, 2.3 and so on

Any system for numbering the pages of an application may be used, if it is consistent throughout the application and is accurately reflected in the table of contents.

Applicants do not need to erase page numbers on copies of other documents included in an application unless those page numbers could be confused with the page numbers of the application.

Binding

Data Parts must be bound in one or more volumes with durable covers, preferably the same size as the pages.

The volumes must be free from damaging projections and each volume must be no more than five centimetres thick.

If an application requires submission of different data Parts (eg chemistry and efficacy and residues), each data Part must be submitted as a separate bound volume. Different data Parts must not be combined within the same bound volume.

Larger applications may need to be broken down into several volumes, with each data Part contained in a separate volume. Individual Parts, if very large, may need to be broken down into several volumes. For example, the different sections of Part 3 (Toxicology) may need to be presented in separate volumes.

Binding that allows volumes to be easily opened for reading and evaluation must be used. Plastic spiral binders and plastic arnos-type fasteners are suitable.

Metal arnos-type fasteners and ring binders are not acceptable because they often open during transport.

If data are not bound properly there is a risk that data could be separated during transport which will not only cause delays but may result in confidential commercial information going astray. Proper binding of data is also a National Archives of Australia requirement.

If the APVMA receives bound data in an unacceptable format, they will be returned to the applicant for appropriate binding.

Number of copies required

The number of copies required will depend on how many agencies must evaluate the application. Applicants should initially send one unbound copy of Part 1 (Application Form and Overview) and one bound copy of all other volumes. The APVMA will use the volumes for screening purposes. Once the submission has passed screening, the APVMA will advise the applicant how many copies of each Part are needed to progress the evaluation.

4.6.   Electronic Application Registration System (EARS)

In May 2007 the APVMA released EARS client software which enables applicants to electronically complete and submit Category 8, 12 and 13 applications to the APVMA.

To use the EARS software, applicants must complete the EARS user enrolment form.

Once enrolled, the APVMA provides applicants with a username, account ID, and a CD with the EARS software.

Account holders can use EARS to submit electronic applications over a secure encrypted internet connection to the APVMA for application categories 8, 12 and 13.

4.7.   Electronic submissions of data

The APVMA accepts electronic submissions of data for applications to register veterinary or agricultural products. Further information is available in the Guidance for electronic registration available from the APVMA website.

This document sets out the APVMA’s requirements for preparing and submitting electronic dossiers. It includes instructions on both the software requirements together with guidance on the submission process and format in which the data should be submitted.

Supporting data can be supplied in CD-Rom or DVD format.

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REVISION HISTORY

Revision Date Description of Revision

1 July 2005

First edition

1 October 2005

Second edition

  • requirement for bound data clarified in paragraphs 4.1 and 4.5
  • paragraph 5.9.4: insert hyperlink to form for Changes to Registration Records.

1 April 2006

Third edition

  • paragraph 4.1 (data) and 4.5 (binding): added statement that different data parts must be submitted as separate bound volumes
  • paragraph 4.2: changed addressee for submitting applications
  • paragraph 5.3: edited to clarify the treatment of applications that do not pass screening
  • added new paragraphs 5.3.2 and 5.3.3 on treating applications as having been withdrawn, and rejecting applications
  • added new paragraph 5.4.4 to explain the difference between clock time and elapsed time.

1 July 2007

Fourth edition

  • revise section 3 (approved persons) for clarity
  • add new paragraph 4.6 re electronic submissions
  • add new paragraph 4.7 re EARS
  • add new paragraph 5.4 re screening timeframe
  • general text edits.
20 July 2010

Fifth edition