Agricultural Manual of Requirements and Guidelines - Ag MORAG

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The Registration Process

This page outlines the registration process 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

The Agvet Code states that the APVMA must grant an application for:

registration of a product, or
approval of an active constituent, or
approval of label instructions, or
variation of the particulars or conditions of a registration or approval;
- if it is satisfied that a product, when used according to its proposed instructions, complies with all the relevant criteria outlined in either section 14 (registration or approval) or section 29 (variation) of the Agvet Code.

The relevant criteria include that when a product is used according to the instructions contained on its label, it would:

not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
not be likely to have an effect that is harmful to human beings; and
not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
not unduly prejudice trade or commerce between Australia and places outside Australia; and
be effective according to the criteria determined by the APVMA for the product.

The relevant criteria also cover the provision of label instructions plus any other samples and information deemed relevant and required by the APVMA.

If the APVMA is not satisfied that an application and/or product complies with all the relevant criteria it must refuse the application.

The APVMA processes applications in accordance with the APVMA Quality System which has been developed to ensure that:

all legislative responsibilities are met
determinations are consistent and timely
communication with applicants is concise and clear
process is transparent.

This document gives an overview of the APVMA processes for dealing with an application for:

registration of a new agricultural or veterinary chemical product
variation of the particulars or conditions of a registered agricultural or veterinary chemical product, or an approved active constituent
approval of label instructions.

2. Overview of the Registration Process

Figure 1 gives an overview of the registration process which has four main stages – Receive, Screen, Evaluate and Determine. Each of these stages is in turn comprised of a number of steps which are covered in detail throughout this chapter.

Figure 1: Overview of the registration process

2.1 Receive

The APVMA records lodgement of new applications, data and other related correspondence. It creates application records and files, and receipts any submitted money. The APVMA records correspondence relating to existing applications.

2.2 Screen

All applications must undergo a preliminary assessment (screen) to ensure they comply with the APVMA requirements. Only applications which pass screening, i.e. fully comply with APVMA requirements, will be acknowledged and proceed to a full evaluation.

The APVMA has 30 calendar days to screen an application and to identify whether the application is complete or contains any deficiencies. If the APVMA decides that an application is incomplete, incorrect or does not contain relevant data, it notifies applicants of any deficiencies and what they are required to do to rectify them. Once an applicant is notified of any deficiencies, the time taken for them to respond plus any further assessment at screening is not included as part of the 30 days screening period.

Screening is finalised when the APVMA acknowledges the application as being complete and correct including the full fee and required number of copies of data. Screening is also finalised if the application is rejected or withdrawn.

Screening of applications is discussed in more detail in section 5.

2.3 Evaluate

The evaluate stage consists of – data circulation, evaluation and address deficiency. During data circulation, any submitted data is forwarded to relevant agency/reviewers that are involved in the evaluation of the application. Refer to chapter 10 for further details.

Evaluation, or technical risk assessment, is the process of assessing all information provided with the application to ascertain whether the APVMA can be satisfied that the product complies with all the relevant criteria in the Agvet Codes.

If an application does not comply with all the relevant criteria, it contains a deficiency. The APVMA notifies the applicant of any deficiency and, if applicable, what the applicant must do to address it. For the APVMA to grant an application, the applicant must address all deficiencies so the APVMA is satisfied that the application complies with all relevant criteria.

The evaluate stage of an application is complete when an APVMA evaluator (PE) has given a complete finalisation report to the APVMA delegate for determination of the application, i.e. to either grant or refuse the application or to treat it as having been withdrawn.

Evaluation of an application is discussed in more detail in section 11 Evaluating an application.

2.4 Determine

The determination of an application is the decision of the APVMA whether to grant or refuse an application, or to treat it as having been withdrawn. The PE of an application (i.e. the officer undertaking the overall evaluation and making a recommendation) is a different officer to the officer who determines the application. APVMA officers who determine applications have received the appropriate delegation from the CEO to undertake these decisions in accordance with the legislation.

A delegate’s determination of the application is primarily based on the recommendation of the PE, however, the delegate has the discretion to make a determination that varies from the recommendation.

If the APVMA grants an application, registration occurs when the APVMA enters the appropriate information in the register and notifies the applicant accordingly.

If the APVMA refuses an application, or treats it as having been withdrawn, the APVMA notifies the applicant accordingly.

Determining an application is discussed in more detail in section 18 Determining an application.

3. Pre-application Advice

3.1 Application category, label claims, data requirements

Applicants may contact the APVMA to request pre-application advice on:

the application category, fee and timeframe which is likely to apply to the application
proposed label claims
data requirements and likely data waivers
design of experimental trials.

Applicants should note that while the APVMA will provide a reasonable level of advice on processes and requirements, it cannot assist in the preparation of an application or act as a consultant during the screening and evaluation of an application.

When seeking advice on the appropriate category and data requirements, applicants must ensure that the information they submit to the APVMA is complete and accurate. Advice given by the APVMA is not binding. Once an application is lodged, the APVMA will always consider previously given advice when screening the application. If an applicant varies an application after the APVMA has given advice, the APVMA may view its previous advice as no longer relevant.

Once an application is lodged, the APVMA will screen the application and accompanying information. Delays are likely to occur if an application is made under the wrong category or lacks sufficient information. It may even be refused or treated as having been withdrawn. Applicants who are not sure of the appropriate application category and requirements should seek advice from the APVMA prior to lodging an application.

3.2 Trial protocol assessment

Applicants may apply under Category 25 for the APVMA to assess the design of a trial (trial protocol) they propose to conduct for the purpose of generating data, most commonly residues data or efficacy/safety data.

The APVMA usually engages outside experts to assess the trial protocol and advise the APVMA whether the proposed trial protocol is capable of generating data to meet the APVMA’s requirements for the particular data part.

The APVMA’s assessment of a trial protocol does not necessarily mean that the data obtained from the trial will be supportive and lead to the APVMA granting an application.

The APVMA makes its final determination on whether to grant an application for registration or variation on the basis of its consideration of a full submission of all data for all relevant data parts, according to whether it is satisfied that an application complies with all the relevant matters in the Agvet Code.

3.3 Pre-submission data assessment

Before lodging an application for registration of a product, an applicant may make a Category 25 application for pre-submission data assessment. The most common reason for doing this is to obtain the APVMA’s assessment of a data part which might be contentious. In this way, the applicant can decide whether or not to proceed with a full application.

3.4 Project management approach to applications

The APVMA encourages applicants to adopt a ‘project management’ approach in regard to the planning and lodgement of major applications (e.g. new products containing new active constituents). A project management approach will provide greater certainty and predictability in regards to resources, data requirements and timeframes.

In a project management approach, an applicant has a pre-application meeting with the APVMA and relevant agencies/reviewers to discuss the proposed product. This meeting would also cover a list of proposed data or studies that are required, a projected time line for completion of studies in progress or studies yet to be done, draft label instructions and indication of the time plan for lodgement and company ‘season’ launch goal. A combined project plan is then developed. Further details on project management approach to applications is covered in section 17.1 Project management of applications.

4. Lodging an Application

When the APVMA receives a new application it records the details on a database and allocates the product or active constituent a unique National Chemical Registration Information System (NCRIS) number. The NCRIS number remains with the product or active constituent for the life of the product or active constituent.

Each application is also allocated an Application Tracking System (ATS) number. Over the life of a product, several applications to vary registration particulars or labels may be made, and the APVMA uses the ATS number to individually identify each new application.

The NCRIS and ATS numbers are generally given in the format:

Product No: 56789; Application No: 34567 or Application Reference No.: 56789/34567.

Applicants must quote the ATS or reference number when corresponding with the APVMA to ensure that the correspondence is matched with the appropriate application.

Within ten days of an application being lodged, the APVMA sends a notice to the applicant confirming receipt.

4.1 Property of the APVMA

Section 169 of the Agvet Code provides that all applications lodged with the APVMA become the property of the APVMA.

4.2 Electronic Application and Registration System (EARS)

Applicants have the option to lodge some applications using the Electronic Application and Registration System (EARS). Further details on EARS can be obtained from the Registration section of the APVMA website.

5. Preliminary Assessment (screening)

All applications must undergo a preliminary assessment (screening) to ensure they comply with APVMA application requirements. Only applications which pass screening, i.e. they fully comply with the APVMA application requirements, will proceed to a full evaluation.

An application that does not comply with a requirement may be incomplete, incorrect or not contain relevant data, any of which will impede a proper evaluation. An application that does not comply with a requirement contains an application deficiency. The APVMA will require the applicant to rectify all application deficiencies before the APVMA can accept the application for evaluation. Incomplete applications may be accepted for evaluation if they are submitted as a Timeshift application (refer to 17 Timeshift applications).

The screening of an application comprises an administrative screening and a technical screening.

The technical screening may also include agency screening which involves screening of an application and/or data by officers from Office of Chemical Safety (OCSEH) in the Department of Health and Ageing, officers from the Department of Sustainability, Environment, Water, Population and Communities (DSEWPC), and/or APVMA Chemistry or Residue evaluators.

5.1 Administrative screening

An application generally undergoes an administrative screening within a few days of being lodged. Administrative screening occurs in the order in which applications are received and involves a check to ensure an application complies with all administrative requirements, such as:

the appropriate application form is complete and signed by an approved person
supplied information is legible with corrections appropriately initialled
applications to vary existing registered products contain registrant’s details that match those on the APVMA register
if required, an appropriate registered reference product is nominated
the data list has been submitted in appropriate format
a minimum screening fee has been paid unless the application is made via EARS or under Category 13.

If a minor application deficiency is identified or if the APVMA requires clarification of a matter, the APVMA may contact the approved person by phone, email or fax. Examples of minor deficiencies include, but are not limited to:

no or insufficient application fee provided
no electronic version of the data list
incorrect or unclear Australian Business Numbers (ABNs)
unclear or missing reference product
incorrect or missing information on the application form.

Other more substantial application deficiencies will be included in an appropriate notice and forwarded to the applicant (refer to 6 Applications that contain deficiencies).

An application that complies with all administrative requirements is deemed to have ‘passed’ the administrative screening. An application that does not comply with all requirements, i.e. contains an application deficiency, is deemed to have ‘failed’ the administrative screening. An application must generally pass an administrative screening before it will proceed to a technical screening.

5.2 Technical screening (including agency screening)

During technical screening of an application, APVMA evaluators (PEs) check:

the appropriate data requirements and assessment timeframes which then sets the relevant category for assessment of the application
whether any provided information or data complies with the data requirements and are consistent with the information contained in the data list
if the nominated reference product is suitable
the application complies with data protection provisions
the suitability of the proposed Relevant Label Particulars (RLPs).
that any request for a data waiver with scientific argument submitted in lieu of data is acceptable.

If a minor application deficiency is identified during technical screening or if the APVMA requires clarification of a matter, the APVMA may contact the approved person by phone, email or fax. Examples of minor technical application deficiencies include, but are not limited to:

the purpose of the application is unclear
inconsistencies between submitted data and data list.

If an application contains data, the screening by relevant agencies/reviewers is necessary to establish the appropriate data modules, which then determine the appropriate application fee and timeframe.

The PE decides at the initial technical screening whether the data and/or application are adequate to enable effective screening by an agency/reviewer. If this is not the case, or other more substantial application deficiencies are identified, the PE will send an appropriate notice to the applicant (refer to 6 Applications that contain application deficiencies).

An application that complies with all technical requirements is deemed to have been acknowledged or to have ‘passed’ screening. An application that does not comply with all requirements, i.e. contains an application deficiency, is deemed to have ‘failed’ technical screening. An application must be acknowledged, i.e. have passed screening before the APVMA will give the application a full evaluation.

Technical screening occurs according to the following timetable:

pesticides (agricultural chemicals) technical screening takes place every Tuesday
agency screening takes place every Wednesday
veterinary medicines technical screening occurs every Thursday.

If an application contains a deficiency, the APVMA will send a notice to the applicant or approved person, usually one to two days after the scheduled technical screening day.

5.3 Data quality

During technical screening the PE and agencies, after ensuring that any provided data meets requirements, may check the quality of the data to ensure that poor quality data do not proceed to evaluation. Poor quality data are unlikely to support the application and therefore adversely impact on the resources of the applicant and the APVMA.

Data quality must be adequate for the study to be relied upon during the evaluation and determination of the application. Checking the quality of the data takes into consideration the adequacy, reliability and the relevance of the data.

If data is of poor quality, the APVMA will notify the applicant and give a brief outline of the reasons why they consider the data to be inadequate to be relied upon for evaluation. The APVMA will request that the applicant notify whether they wish to:

address the data inadequacies during screening process, or
request that the APVMA accept the data in their current form for evaluation, or
submit additional data to address the inadequacies.

Once an application passes screening and undergoes evaluation, the provision of any volunteered data by the applicant will incur an additional fee and timeframe (refer to 15 Volunteering new data).

5.4 Scientific argument in lieu of data

The APVMA recognises that data requirements may not be relevant to every application. Certain products may have unusual properties or a use pattern which may result in data not being essential to satisfy the APVMA that the application meets all the relevant criteria.

Applicants always have the opportunity to request that some data requirements be waived and to provide scientific justification or argument to satisfy the APVMA that the application can comply with a relevant criteria. When seeking a data waiver, applicants must incorporate the request and the relevant scientific argument in the Application Overview in the appropriate section.

When presented with a request for a data waiver and the corresponding scientific argument, the APVMA will consider the argument in the following manner:

During technical screening

If the argument can be assessed during screening, the APVMA will determine whether the argument can be accepted in lieu of the required data. If not, the APVMA will issue a notice of application deficiency to the applicant to provide either the required data or a more valid scientific argument.

During evaluation

If the argument and/or the product is complex, the decision of whether the scientific argument satisfies the APVMA will generally be undertaken during evaluation. This is particularly the case where a scientific argument is submitted in combination with reduced data.

During evaluation, if the APVMA decides, that based on the argument, it cannot be satisfied to grant the application, it will advise the applicant that it is likely to refuse the application. The applicant has the option to:

submit data
provide a more valid scientific argument
vary the application, or
withdraw the application.

If the applicant cannot meet any of these options, the APVMA will refuse the application.

6. Applications That Contain Deficiencies

During screening, the APVMA identifies application deficiencies that the applicant must rectify before the application can progress to a full evaluation. An application must pass administrative screening before it progresses to technical screening. The technical screening may also identify application deficiencies that the applicant must rectify before the application is screened by agencies.

An application will only be passed to the next screening step if the APVMA is satisfied that the application deficiencies are not of a type that would prevent the APVMA from continuing to effectively screen the application.

Section 11A of the Agvet Code provides that if the APVMA identifies an application deficiency at screening, the APVMA must determine whether the deficiency can reasonably be rectified or whether it is of a type that cannot reasonably be rectified.

6.1 Application deficiencies that can reasonably be rectified

The majority of application deficiencies are of a type that the APVMA considers the applicant can reasonably rectify. These application deficiencies include:

missing information and/or data
incorrect information, application form and/or fee
inappropriate product name and/or Relevant Label Particulars (RLPs)
incorrect application category.

When the APVMA identifies these types of application deficiencies, it issues a notice clearly identifying the application deficiencies that the applicant must rectify. If the applicant has applied under the wrong category, the APVMA will advise which category is appropriate.

The notice of application deficiency usually allows the applicant two months to rectify the deficiencies and respond to the APVMA.

6.2 Application deficiencies that cannot reasonably be rectified

The Agvet Code states that an application that contains an application deficiency that cannot reasonably be rectified is an application that has not been properly made and must be rejected by the APVMA.

Examples of application deficiencies that cannot reasonably be rectified include, but are not limited to:

the application is to extend the use of a product contrary to the findings of an APVMA review and no new data are submitted to support the application
the application is for registration of a product containing a persistent organic pollutant or other active constituent which contravenes an international agreement to which Australia is a signatory
the application relies on protected data for which the applicant does not have evidence of consent for use from the data owner and it is evident that data owner will not give consent. In this example, the application may be for registration of a new product which includes uses identical to a similar product where:
- no data are submitted to support the application
- the registration of the similar product relies upon protected data, and
- the applicant for the new product or varied product cannot produce any evidence to demonstrate that they have consent from the data holders to use the protected data
the application is for registration of a product for use in an animal species, where the active constituent is well known to be toxic to that animal species and no new data or information are submitted to support the application.

In such cases, the APVMA issues a notice to the applicant outlining the reasons why the APVMA proposes to reject the application. The applicant has the option to withdraw the application or to provide valid justification why the APVMA should not reject the application. If the APVMA is not satisfied with the applicant’s response or does not receive a response by the due date, the APVMA will reject the application. When the APVMA rejects an application, it will refund the application fee apart from the screening component.

7. Applicant Response to Notice of Application Deficiency

The APVMA issues a notice of application deficiency to the applicant outlining the deficiencies and what the applicant can do to rectify them. The notice generally allows the applicant two months to respond.

If an applicant does not respond by the due date, the APVMA will issue a reminder notice. If the applicant does not respond to the reminder notice by the due date, the APVMA will treat the application as having been withdrawn.

When an applicant responds by the due date, the APVMA considers whether the submitted information and/or data are adequate or technically sufficient to rectify the application deficiencies and allow the application to proceed.

If the response does not address and rectify all the application deficiencies, i.e. it is not a complete response, the APVMA will issue a second notice detailing the deficiencies that the applicant must still rectify. If the applicant’s second response does not rectify the application deficiencies to the satisfaction of the APVMA, the APVMA will treat the application as having been withdrawn.

The onus is on the applicant to address any identified application deficiencies to the APVMA’s satisfaction. The APVMA does not intend to issue more than two notices before determining whether the application meets all the requirements or to treat the application as having been withdrawn. The APVMA will only issue another notice of application deficiency if they are satisfied that the applicant is making a genuine attempt to rectify any application deficiencies and only minor deficiencies remain.

7.1 Varying application details or category

The screening process does not restart from the beginning if an applicant, in responding to a notice of application deficiency, changes an application category and/or provides new information to support the new application category. If the amended application also contains a significant application deficiency, the APVMA is likely to treat the application as having been withdrawn. If the amended application contains no application deficiencies, it will proceed to a full evaluation.

Example

An applicant applies under Category 7 for registration of a new product which the applicant considers is closely similar to a nominated reference product. The APVMA is not satisfied that the new product is closely similar to the nominated reference product and send a notice of application deficiency to the applicant.

In response, the applicant amends their application to a Category 5 application and provides chemistry and manufacture data and bioequivalence data. At technical screening, the APVMA is not satisfied that the provided data complies with requirements. The APVMA does not issue a further notice of application deficiency and the APVMA treats the application as having been withdrawn.

If an application category must be changed, it does not mean that the screening process starts from the beginning. Applicants who are not sure of the appropriate application category and requirements should seek advice from the APVMA prior to lodging an application.

Note: For applications submitted under Category 5, 6 or 7, the APVMA will not accept a request to amend the formulation of a product or to nominate a new reference product where the request is in response to a notice of application deficiency advising that the proposed product’s formulation is not considered ‘similar’ or ‘closely similar’ to the nominated reference product.

Apart from very minor changes, such as correcting typographical or other minor errors, the APVMA cannot allow applicants to vary formulations by ‘guessing’ the formulation of the nominated reference product. Similarly, the APVMA will not accept a request to nominate a new reference product. It is the applicant’s responsibility to be sure that the nominated reference product is ‘closely similar’ to the proposed product prior to lodging an application for a Category 6 or 7.

7.2 Applicant cannot rectify application deficiency

If an applicant is unable to submit the necessary information required to rectify an application deficiency by the due date, they may:

advise the APVMA that they wish to withdraw their application. This advice must be in writing and must be signed by the approved person; or
request the APVMA to defer consideration of the application until a further date when the required information will be available, or
provide a reason why the applicant believes that the provision of such information is not necessary for the application to comply with all requirements.

A request to defer consideration must include a brief summary of the actions the applicant intends to take. While each case is assessed on its merits, the APVMA is reluctant to defer consideration of an application for a period longer than six months unless the applicant can adequately justify why such a time period is necessary.

Applicants who do not wish to provide requested information must give a reason or justification why they consider the information is not necessary for the application to fully comply with all requirements. If the reasons do not satisfy the APVMA, the APVMA will issue a second notice requiring the applicant to rectify any remaining application deficiencies.

7.3 Withdrawn applications

An application can be withdrawn by:

the applicant advising the APVMA that they wish to voluntarily withdraw their application. A request to withdraw an application must be in writing and must be signed by the approved person.
the APVMA treating an application as having been withdrawn if the applicant does not give a complete response to a second notice of application deficiency or to a reminder notice.

When an applicant voluntarily withdraws an application during screening, or the APVMA treats the application as having been withdrawn during screening, the APVMA will refund the application fee apart from the screening component.

7.4 Rejected applications

The APVMA may reject an application at screening that contains an application deficiency that cannot reasonably be rectified, on the grounds that the application has not been properly made. If the APVMA rejects an application at screening, it will refund the application fee apart from the screening component.

8. Screening outcomes

At the conclusion of application screening, there will be one of the following outcomes:

the application complies with all requirements (including fee and/or copies of data), is acknowledged and proceeds to a full evaluation
the APVMA rejects the application on the grounds it has not been properly made; or
the APVMA treats the application as having been withdrawn; or
the applicant voluntarily withdraws the application.

8.1 Applications evaluated during screening

For some less complex applications, and for efficiency reasons, the APVMA may evaluate the application against the relevant criteria during technical screening. For such applications, the screening, evaluation and determination all occurs within the screening process and timeframe.

9. Acknowledgment of Application

Once application screening is completed, the APVMA issues a notice advising the applicant whether the balance of the fee must be paid. If the application requires data evaluation, the notice will also advise the applicant whether they must submit additional copies of data.

Once the APVMA receives the complete application fee and the required number of copies of data, the application is assigned to an Evaluator (PE) and the full evaluation of the application commences.
The date that the application is acknowledged, is the date on which the APVMA:

is satisfied that the application contains no deficiencies, and
receives the complete application fee and data copies

The day following the day an application is acknowledged marks the start of clock time for the application as specified in Schedule 6, Part 2 of the Agvet Code Regulations (also refer to section 20 Principles of clock management).

9.1 Applicant does not submit fees and/or data

The onus is on the applicant to provide the correct fee and appropriate number of copies of data in the correct format by the due date.

If an applicant does not respond by the due date, the APVMA issues a reminder notice. If the applicant does not respond to the reminder notice by the due date, the APVMA will not consider the application any further and will treat the application as having been withdrawn.

If an applicant does reply by the due date, but does not provide the appropriate fee and/or sufficient copies of data in the required format, the APVMA will issue a second notice listing the fee and/or copies of data that are still required. If the applicant does not satisfy the APVMA with their second response the APVMA will not consider the application any further and will treat the application as having been withdrawn.

9.2 Application summaries

Shortly after the application is acknowledged and evaluation commences, the APVMA will publish a ‘summary of application’.

10. Data circulation

The PE conducts the evaluation, or technical evaluation and risk assessment, of the application and coordinates advice from sections within the APVMA plus from agencies/reviewers. The PE is the contact point between the applicant and the APVMA in dealing with the application.

Table 1 lists the external agencies and other APVMA evaluators who provide expert advice:

Table 1 : Agency reviewers and other Evaluators who provide expert advice to assist the PE

Application Part	Agency/Reviewer
Part 1 - Application Overview	PE, all relevant agencies
Part 2 - Chemistry and Manufacture	Chemistry, MQL, all relevant agencies
Part 3 - Toxicology	OCSEH
Part 4 - Metabolism and Toxicokinetics	Residues, OCSEH, DSEWPC
Part 5A - Residues	Residues, PE
Part 5B - Overseas Trade Aspects	Residues, PE
Part 6 - Occupational Health & Safety	OCSEH (OHS)
Part 7 - Environment	DSEWPC
Part 8 - Efficacy and Safety	PE, external efficacy reviewer
Part 9 - Other Trade Aspects	PE
Part 10 - Special Data Requirements	PE, relevant agencies (OGTR, NHMRC)

Chemistry - APVMA Chemistry Section
DSEWPC - Department of Sustainability, Environment, Water, Population and Communities
MQL - APVMA Manufacturing Quality and Licensing Section
OCSEH (OHS) - Office of Chemical Safety & Environmental Health (Occupational Health and Safety)
OCSEH - Office of Chemical Safety & Environmental Health
OGTR - Office of the Gene Technology Regulator
Residues - APVMA Agricultural or Veterinary Residue Section
PE - APVMA Pesticide or Veterinary Medicine evaluator
NHMRC - National Health and Medical Research Council

11. Evaluating an Application

The evaluation of an application is the detailed technical evaluation and risk assessment of all information provided with the application, including data, against the relevant criteria. The evaluation of a product also includes the assessment of the Relevant Label Particulars (RLPs) against all the statutory requirements of the Agvet Code and also further APVMA requirements set out in the appropriate Labelling Standard. The criteria that the APVMA must consider and be satisfied of are included in section 14 (new product) or section 29 (variation) of the Agvet Code.

The evaluation determines whether the use of the product in accordance with its instructions for use:

would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
would not be likely to have an effect that is harmful to human beings; and
would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
would not unduly prejudice trade or commerce between Australia and places outside Australia; and
would be effective according to the criteria determined by the APVMA for the product.

In satisfying itself of the above matters, the APVMA must also undertake a detailed technical assessment of matters pertaining to the active constituent and the formulation of the product as detailed in the Agvet Code. The PE includes their evaluation of an application in the Technical Evaluation and Risk Assessment section (TERA) of the Finalisation Report.

11.1 Requirement to provide clarification

During evaluation, the PE or agencies/reviewers may require the applicant to provide information and/or clarification to enable the evaluation to proceed. This situation most commonly arises where the data and/or information submitted are generally adequate, but the APVMA requires some minor supplementary information to clarify or confirm their interpretation. This does not include cases where the submitted data have significant gaps or are otherwise inadequate.

If clarification is required, the APVMA will issue a notice to the applicant under section 159 of the Agvet Code detailing the information that the applicant must provide. Applicants are usually given two months to respond.

When an applicant responds, the APVMA checks to see whether the response is complete, i.e. whether the applicant has addressed each of the requirements.

Whether the response clarifies the matter or provides information to the satisfaction of the APVMA will be decided by the PE or agency/reviewer during the evaluation. A response may be complete but still not contain the information that the APVMA requires to fully evaluate the application.

If an applicant does not respond by the due date, the APVMA issues a reminder notice. If no response to the reminder notice is received by the new due date, the APVMA treats the application as having been withdrawn.

If an applicant does reply by the due date, but the response is not complete, i.e. the applicant has not responded to each of the requirements set out in the notice, the APVMA will issue a second notice detailing the requirements that the applicant did not respond to. If the applicant does not give a complete response with their second response, the APVMA will not consider the application any further and will treat the application as having been withdrawn.

Note: A requirement to provide clarification and/or information at this stage of the evaluation process does not include a requirement to provide new data where the initially submitted data does not satisfactorily support the quality, safety or efficacy of the product and/or active constituent.

11.2 Early release of advice to applicant

The assessment of data against a particular criteria generally results in the relevant agency/reviewer (external or internal to the APVMA) generating a report which is provided to the PE. The report contains advice on whether the product, when used as proposed, complies with the specific relevant criteria.

When a report is received by the PE, it is checked to ensure that the report meets agreed format and quality standards. If a report contains advice that:

does not support the proposed product or use; and/or
recommends certain conditions with which the applicant may not agree

the PE will arrange for the applicant to receive a copy of the report.

A notice will accompany the report advising applicants that they have between 14-28 days to respond to any adverse advice. Any relevant comments from the applicant will be considered in the overall evaluation. Once an evaluation is complete, the PE will identify any deficiencies that the applicant must address (refer to 12 Addressing a deficiency).

For many applications, when releasing a report to applicants for their comment, the PE will not make any requirement of the applicant. Any necessary requirements are generally made when the evaluation is complete and all deficiencies have been identified.

In some cases, depending on the nature of the application, the PE may give a copy of the report and include a requirement in the accompanying notice. In such cases, the applicant has the opportunity to respond to the advice in the report and whether the requirement is warranted.

If a report contains commercially confidential information (CCI) that the applicant is not authorised to access, the APVMA will only send a summary of the advice and ensure that this summary does not contain CCI.

12. Addressing a Deficiency

The APVMA completes the evaluation of an application when it has evaluated the submitted data and/or information, checked the proposed Relevant Label Particulars (RLPs), and taken into account any response from the applicant regarding a report (see section 11.2 Early release of advice to applicant). The evaluation of an application identifies whether or not the APVMA is satisfied that an application complies with all the relevant criteria.

The Agvet Code states that when the APVMA is satisfied that an application complies with all the relevant criteria, it must grant the application. If the APVMA is not satisfied that all relevant criteria have been complied with, i.e. the application contains a deficiency, it must refuse the application. The APVMA will not refuse an application without giving the applicant an opportunity to correct or address the deficiency in their application.

The applicant must address all deficiencies before the APVMA will grant an application. Once an evaluation has been undertaken and a deficiency has been identified, the APVMA determines the appropriate response to the applicant which is primarily based on the nature and extent of the deficiency. The possible responses from the APVMA to a deficiency are:

Likely to grant
Amend application
Supplementary data
Likely to refuse

The APVMA issues a notice (deficiency or requirements notice) to the applicant identifying a deficiency and, if appropriate, what the applicant is required to do to address the deficiency. Addressing a deficiency may require the applicant to either provide additional information or amend the application to enable the APVMA to be satisfied that the application complies with all the relevant criteria.

Generally, a deficiency or requirements notice is issued after the evaluation is complete, i.e. when all provided data/information and the Relevant Label Particulars (RLPs) have been evaluated and all deficiencies identified. However, as indicated in 11.2 Early Release of Advice to Applicant, a PE may issue a requirements notice based on the outcomes of an agency or reviewers report, while other data are still undergoing evaluation. In such cases, the PE will advice the applicant if the evaluation is complete or whether other requirements may result once evaluation of remaining data occurs.

12.1 Likely to grant

The APVMA is satisfied that the application either fully complies (i.e. no deficiencies) or will comply with all the relevant criteria once the applicant addresses some minor administrative matters.

12.2 Amend application

The APVMA is not satisfied that the application complies with all the relevant criteria. To address the deficiency, the applicant is required to make minor amendment/s to the Relevant Label Particulars (RLPs) and/or application details. Examples of minor amendments include:

changes to instructions to mitigate risks to the safety of users, the environment or target crops/animals to an acceptable level;
changes to instructions to ensure efficacy of the product;
where a product contains a range of uses, the removal of a use that does not change the overall nature of the product;
changes to instructions to mitigate risks due to residues in crops, or food or fibre-producing animals to an acceptable level.

The APVMA will assess each application on its merits to decide whether the required amendment to the application is minor.

12.3 Supplementary or required data

The APVMA has undertaken an evaluation of the application. Due to certain data omissions or incompleteness the APVMA cannot be satisfied that the application complies with all the relevant criteria. To address the deficiency, the applicant is required to provide the missing or supplementary data or scientific argument in lieu of the data.

Generally, a requirement to provide missing or supplementary data is made when:

the data should have formed part of the initially submitted data; and
sufficient time remains under the existing evaluation and agency/reviewer timeframes to assess the data.

12.4 Likely to refuse

The APVMA has evaluated the application and all submitted data and is not satisfied that the application complies with all the relevant criteria unless the applicant makes significant changes to the application, Relevant Label Particulars (RLPs) and/or submits substantial new data.

Examples of significant changes include:

deleting uses from RLPs that affect the overall nature of the product. For example, where removal of a use will contradict the product name such as a Cattle & Sheep Dip where the data does not support use on sheep; or a Snail Bait with Rain Fastness where rain fastness is not supported;
submitting substantial new data. New data is defined as data other than supplementary or required data and will result in the APVMA needing to undertake further evaluation that is additional to the initial evaluation which will also require a new timeframe; and/or
changing the formulation of the product.

The APVMA will generally not require an applicant to make significant changes to an application or RLPs or to submit new data. An applicant may volunteer to make significant changes to their application or RLPs or volunteer new data to the APVMA anytime after the application has been acknowledged and evaluation has commenced. The submission of new data is subject to an additional timeframe as outlined in section 15 Volunteering new data.

Note: The above examples are for guidance. The appropriate APVMA response and the necessary steps or requirements that an applicant must follow to address a deficiency is made by the PE once all matters are taken into consideration. For example, due to the nature of an application, the PE may decide that it is appropriate to require an applicant to incorporate significant RLP changes to address a deficiency.

13. Notice of Requirements

If the:

application is likely to be granted if the applicant addresses a minor administrative issue, or
applicant is required to amend the application and/or RLPs; or
applicant is required to provide some supplementary data

then the APVMA issues a notice of requirements to the applicant listing the things that the applicant is required to do to address a deficiency. A notice of requirements is issued under section 159 of the Agvet Code.

When the APVMA issues a notice of requirements, it turns the application time clock to OFF, and applicants generally have three months to respond. The application time clock is turned to ON when the applicant provides a response (refer to section 20 Principles of Clock Management).

If applicant responds by the due date, the APVMA checks whether the response is complete. That is, whether the applicant has responded to each of the requirements. The APVMA will only further assess the response if it is complete.

13.1 Responding to notice of requirements

The onus is on applicants to address all requirements to the satisfaction of the APVMA by the due date.
If an applicant cannot address all the requirements by the due date an applicant has the option to:

Advise the APVMA that they wish to withdraw the application

This advice must be in writing and must be signed by an approved person.
Request the APVMA to suspend the application until the applicant will provide required information

If an applicant intends to request the APVMA to suspend consideration of the application, they must also outline the actions they will take to address the requirement and indicate when they will provide the information.

Whilst each case is assessed on its merits, the APVMA is reluctant to suspend an application for longer than 6 months without sufficient justification.

The APVMA may refuse a request to suspend an application if the applicant does not provide the date the information will be available. Furthermore, the APVMA is unlikely to suspend an application on more than one occasion.
Provide justification why a requirement is not necessary

The APVMA is prepared to review a requirement if the applicant can provide sufficient justification why a specific requirement does not need to be addressed for the application to comply with all the relevant criteria.
Propose an alternative approach that would address a deficiency

The applicant may volunteer to amend the product and/or RLPs in a way to address a deficiency (for example, removing certain uses). The applicant may also volunteer to provide new data (see section 15 Volunteering new data).

The APVMA will assess a response on its merit whether it satisfactorily addresses a deficiency.

13.2 No response by due date

If the applicant does not respond by the due date, the APVMA will issue a reminder notice. If the applicant does not respond to the reminder notice by the due date, the APVMA will not consider the application any further and will treat the application as having been withdrawn.

13.3 Response is not complete

If the applicant responds by the due date, but the response does not address all the requirements, i.e. it is not a complete response, the APVMA will issue a second notice detailing the requirements that the applicant must still address. If the applicant’s second response is not a complete response the APVMA will not consider the application any further and will treat the application as having been withdrawn.

13.4 Response does not address requirements

If the applicant responds with a complete response by the due date, but the provided information does not satisfactorily address the requirements, the APVMA will issue a second notice of requirements.

If the applicant’s second response is complete but still does not address all requirements, i.e. it does not satisfy the APVMA that the application complies with all the relevant criteria, the APVMA will refuse the application.

13.5 Only two notices of requirements

The APVMA will generally only issue two notice of requirements for an application before determining whether to grant the application, to treat the application as having been withdrawn or to refuse the application. The onus is on the applicant to respond to a notice of requirements by the due date and to ensure that all requirements are addressed to the satisfaction of the APVMA.

14. Notice Proposing to Refuse an Application

If the APVMA is unlikely to be satisfied that the product, when used as proposed, can comply with all the relevant criteria, it must refuse the application. This is likely to occur if the evaluation of the application identifies a significant deficiency. A significant deficiency cannot be addressed by a minor change to the application and/or RLPs or the provision of supplementary data.

Prior to refusing an application, the APVMA issues a notice to the applicant advising that it is proposing to refuse the application and a summary of the reasons. The notice also provides the applicant with an opportunity to:

Provide a reason why the APVMA should not refuse the application

The applicant may provide justification why they believe that the application does not contain a deficiency. That is, why they believe that the application complies with all the relevant criteria; or
Provide an alternative approach that would address the deficiency

In providing an alternative approach, the applicant may advise the APVMA that they intend to significantly amend the application and/or volunteer new data. The APVMA will agree to this approach provided that the amendment to the application or the new data addresses the deficiency identified in the notice and is not aimed at extending the use of the product from the current application.

The APVMA normally gives applicants two weeks to respond to a notice that the APVMA is proposing to refuse an application.

14.1 Refuse an application

The APVMA will refuse an application if:

the applicant does not respond to the notice of likely refusal by the due date; or
the applicant responds by the due date but the response does not satisfy the APVMA that the applicant has provided a reason for the APVMA not to refuse the application.

The APVMA will notify the applicant of application refusal and a brief statement of reasons. The APVMA does not refund any fees when it refuses an application.

15. Volunteering new data

An applicant may voluntarily submit new data during the course of an evaluation of an application. The reason for submitting new data may be:

to provide additional support for an application
in response to a notice informing the applicant that the APVMA proposes to refuse an application.

When volunteering new data, the applicant should note the following:

all new data must be accompanied by a data list covering all the new studies;
all volunteered new data will be subject to a new timeframe commensurate with the level of evaluation required to thoroughly assess the new data as per Agricultural and Veterinary Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008;
the new data will be checked by the APVMA for relevance prior to accepting the data for evaluation.

16. Public consultation

Under section 13 of the Agvet Code, the APVMA is required to undergo public consultation for a new product that contains a new active constituent prior to approving the active constituent or granting registration of the product.

During the public consultation process, the APVMA invites the public to raise matters of concern about human and environmental safety and trade. The APVMA considers all relevant comments before making its final determination whether to approve the active constituent and register the product.

If the product is to be used on a crop or food or fibre-producing animal species, the APVMA publishes a public release summary (PRS) which is a summary of the technical evaluation. For all new products based on existing active constituents or currently registered products where a new use in crops or food or fibre-producing animal species is proposed, the APVMA issues a trade advice notice (TAN) to relevant stakeholders. The TAN invites comment on trade related aspects of the proposal to register the product.

17. ‘Timeshift’ Applications

For a Timeshift application, applicants may request the APVMA to accept an application which does not contain all required data, i.e. the application would not be complete in regards to all the data required for the application at time of lodgement.

If the APVMA agrees to a Timeshift application, it screens and evaluates the data that has been provided on the understanding that an applicant will submit the remaining data when it becomes available. All Timeshift applications are treated as modular applications.

When proposing a Timeshift application, the applicant should note:

applicants must clearly identify what data is initially submitted with the application and what data will be submitted later. All other information regarding the application (form, RLPs, etc.) must be submitted with the initial application;
applicants must clearly identify when the remaining data will be submitted. The APVMA is reluctant to agree to long periods (longer than six months) between the application being lodged and the submission of remaining data;
if the APVMA has completed evaluation of the available data before submission of the remaining data, the application will be suspended until the remaining data is provided;
the complete modular fee for the initial data Parts must be paid before the APVMA will accept the application and commence evaluation.
- there is no additional screening fee when the remaining data is provided, but there will be a screening period to ensure that any new data is complete and to establish the appropriate level of assessment.
- applicants must pay the additional modular fees when providing the remaining data.
there are some limitations in the order in which data must be provided. For example, the APVMA cannot evaluate residue data until the relevant chemistry and toxicology data has already been provided.

The current statutory timeframes are for complete applications. In the case of a Timeshift application, the overall target date is generally set by the applicant’s project plan for the application rather than the statutory timeframe set by the Agvet Regulations. Refer to section 20.11 for details of clock management for a Timeshift application.

17.1 Project management of applications

The APVMA encourages applicants to adopt a project management approach for new major applications. This would improve certainty and predictability for registration finalisations. Such an approach would involve liaison and co-ordination between industry and the APVMA (including external agencies) during the development of the submission dossier and during the screening and assessment.

Pre-submission Plan

Figure 3: Project management of a major application

Stage 1 – Entry presentation meeting

The applicant requests meeting with the APVMA and external agencies assessors. The applicant provides an overview of the application, a list of studies to be submitted including a projected time for completion for studies in progress or studies yet to be done, draft RLPs and indication of the time plan for submission and company ‘season’ launch goal. A combined project plan is developed.

Stage 2 – Feed back on proposed project plan

The APVMA provides feedback on pre-submission project plan taking into account the feasibility of timelines, appropriateness of proposed studies etc.

Stage 3 – Acceptance of project plan

The APVMA and applicant agree to the amended project plan. APVMA and agencies ‘schedule’ work to be undertaken. The applicant must keep the APVMA informed of changes in submission date or details to the agreed project plan.

Stage 4 –Submission of data according to project plan

The APVMA following the agreed project plan, co-ordinates both the APVMA and agencies to a specific screening session, during which the APVMA and agencies screening the application taking into account discussions on the pre-submission project plan and data lists, draft label instructions etc. If the screening goes well, the data conforms and is acceptable to that mentioned in the agreed project plan, the application will proceed to a full evaluation.

Stage 5 – Application assessment begins

Assessment begins in the usual manner, although applications may be “time-shifted”. An extension of this model is to schedule agency assessments to a project plan instead of the current priority queue system based on end-date for assessments.

Stage 6 – Application assessment ends –Registration occurs

This process is best suited to applications for new actives and other major applications (those taking 12 – 15 months). At this stage it would be best to conduct a pilot trial, in which applicants volunteer to have their major applications assessed according to the project management approach.

18. Determining an Application

18.1 Delegations

Determination of an application is the formal APVMA decision on the application and only delegated officers are able to determine an application.

18.2 Determining an application

The APVMA must determine an application once the evaluation is complete, taking into consideration all relevant comments submitted to the APVMA during public consultation process.

The determination of an application can result in the APVMA:

granting the application; or
refusing the application; or
treating the application as having been withdrawn.

A PE prepares a finalisation report that includes a recommendation whether the application should be granted, refused or treated as having been withdrawn. The report and recommendation is forwarded to a delegate who makes the determination.

18.3 Delegate may seek further advice

The delegate may seek advice before deciding whether or not to support a recommendation regarding the granting or refusal of an application. This further advice, or the details of any peer review, is at the discretion of the delegate and will be decided on a case-by-case basis.

If the delegate’s determination of the application varies or is contrary to the recommendation, the delegate will update the evaluation report to reflect the delegate’s final determination.

18.4 Finalisation

When the delegate makes a determination to grant an application, the register is updated to put the determination into effect and the APVMA issues a notice of registration or approval, or variation of registration or approval as the case may be.

Applications for which the APVMA has relied upon advice from an external assessor must also include publication of an Advice Summary.

The APVMA also publishes in the APVMA Gazette the details of new product registrations, and major variations to existing registered products.

18.5 Conditions of registration or approval

The APVMA may place conditions on the registration of a product or on the approval of RLPs. If a registrant fails to comply with the conditions of registration or approval, the APVMA may take compliance action against the registrant including suspension or cancellation of the registration or approval.

19. Reconsideration of Determinations

If an applicant is not satisfied with an APVMA determination such as:

refusal of an application
treating an application as having been withdrawn

they may request a reconsideration of that determination.

If an applicant requests reconsideration of a determination, the APVMA reconsiders its original decision and either confirms, varies or sets aside the original determination. The reconsidered determination is a ‘fresh determination’ and so is made by a delegate other than the delegate who made the original determination.

If the APVMA decides to set aside the original determination, it may also substitute a new determination.

Seeking a reconsideration does not affect an applicant’s rights to also apply to the Administrative Appeals Tribunal for review of the original determination or fresh determination.

20. Principles of Clock Management

20.1 Statutory application timeframes

The timeframe within which the APVMA must determine an application is set out in Schedule 6 of the Agvet Code Regulations. In the case of modular application categories, the timeframe for the modules is set out in Schedule 7 of the Agvet Code Regulation. These timeframes are statutory timeframes.

20.2 Reasons for statutory timeframes

The reasons for setting statutory application timeframes in the Agvet Code were to:

prevent applications being overlooked or unnecessarily delayed due to difficulties with the application,
produce predictability to enable applicants to develop business plans,
remove concerns that some applicants or applications receiving unfair priority over others.

20.3 Measuring timeframes

The APVMA reports on performance against timeframes with the Application Tracking System (ATS) which incorporates a series of clocks that monitor the progress of an application, and records the time taken for an application to be determined.

20.4 Elapsed time

Elapsed time is the overall time taken (in calendar days) for an application to be finalised. Elapsed time for an application is the sum of the time that the clock for the statutory timeframe is ON (action rests with APVMA) plus the time that the clock is OFF (action rests with applicant).

20.5 Statutory timeframes vs. elapsed time

The elapsed time to finalise an application may be considerably longer than the statutory timeframe. Apart from the time taken by the APVMA in processing and evaluating an application, the elapsed time also includes all time taken by applicants to respond to any notice of requirements issued by the APVMA. The elapsed time will also include any period where the application was suspended at the request of the applicant.

20.6 Clock ON and clock OFF

The simple basis for clock management is:

The clock is turned ON when:

The APVMA (including agency/reviewer) has responsibility for the next action or has received a response from the applicant in response to a notice of application deficiency or notice of requirements.

The clock is turned OFF when:

the APVMA has made a regulatory requirement of the applicant (i.e. issued a notice of application deficiency or notice of requirements), or
the applicant has informed the APVMA that they intend to volunteer new data and/or information and no further evaluation of the application can be undertaken until the data and/or information is received, or
the application has been determined, i.e.
- granted
- approved
- registered
- refused
- rejected, or
- treated as having been withdrawn; or
the applicant’s response to a notice of application deficiency or notice of requirements is not a complete response.

Where there is an exchange of correspondence regarding an application, this is part of the time taken to determine the application. Therefore, the clock is ON whenever the APVMA has responsibility for the next action.

20.7 Screening statutory timeframe

The reason for screening of an application is to ensure that the application meets the APVMA’s administrative and technical requirements prior to undertaking an evaluation.

Section 11A of the Agvet Code states that within 30 days of receiving an application, the APVMA must screen the application to determine whether it complies with the APVMA’s requirements, or whether it contains application deficiencies that the applicant must rectify. The 30 days is not the time within which the application must pass screening and move to evaluation.

To assist in minimising the time an application spends at screening, applicants should endeavour to ensure a lodged application is complete and correct and, if required, promptly respond to a notice of application deficiency.

20.8 Application statutory timeframe

The application timeframe starts the day after the date that the APVMA receives a complete application. The timeframe ceases on the date the APVMA makes a determination, i.e. when the application is granted, approved, registered, refused, rejected or treated as having been withdrawn.

From the date evaluation begins to the date when the application is determined, the statutory timeframe is measured by the time when the ATS clock is ON, i.e. when the APVMA is responsible for the next action.

20.9 Clock management when the APVMA proposes to refuse an application

When the APVMA issues a notice proposing to refuse an application, the ATS clock remains ON. The APVMA usually gives applicants 14 days to respond to such a notice.

If the applicant notifies the APVMA that they intend to volunteer new data and/or information at a later date, the APVMA turns the clock OFF because it cannot further consider the application until it receives the new data and/or information.

If the applicant provides a justification why the application should not be refused, the APVMA leaves the ATS clock ON while it considers the reason/s.

20.10 Volunteered new data

If an applicant volunteers new data, the APVMA adds the appropriate module timeframe to the overall application timeframe. The APVMA informs the applicant of the new target date for determining the application.

20.11 Clock management for Timeshift applications

The current statutory timeframes are based on the provision that the applicant will submit a complete application. In the case of Timeshift applications, whilst the APVMA monitors individual data clocks and their respective target dates, the overall application timeframe is generally set according to the applicant’s project plan for the application rather than against a target date based on the statutory timeframe. A target date can only be set once the last remaining data has passed screening.

20.12 Accurate reporting of elapsed time

The recording and reporting of average elapsed time for all applications is to give predictability of the period of time generally needed for an application to be finalised. However, some applications have elapsed times that do not accurately represent how long normal or standard applications take to finalise. Some applications, due to various reasons, result in extended elapsed times that affect the overall reported times and thereby result in statistics that limit their usefulness in giving accurate predictability.

The APVMA reports on elapsed time by separating and reporting separately on the following types of applications:

timeshift applications, i.e. incomplete applications where APVMA agrees to commence evaluating and to accept some data at a later date;
where APVMA has agreed to a request from the applicant to suspend consideration;
where the applicant has volunteered additional data and APVMA agrees to undertake further evaluation;
international workshare applications that progress under different timeframes to standard applications;
have lapsed due to applicants not responding to a notice of requirements and any reminders for a period longer than generally provided for applicants to respond, i.e. 5 months.

21. Work-In-Progress

The APVMA continues to review and change its registration processes in response to new requirements or to incorporate continuous improvement. This chapter will therefore be regularly updated to include new or amended processes.

The APVMA intends to include information on the following in the next version of this document:

Data waivers as a Category 25 application;
Screening processes. The APVMA is currently reviewing its processes undertaken during the screening of applications;
International Joint Review and Workshare arrangements;
MRL harmonisation
Poison scheduling.

22. Process Maps

The process maps form part of the APVMA’s process documentation and are an integral part of the APVMA’s Quality Management System. They are reproduced here without any variation.