The Applicant Guide: General information on completion of the Application Overview

What is the Application Overview?

An introduction to the Application Overview

The draft Registration Report (dRR) provides the detail of the application, but an Application Overview is required to give a summary and context. It may be a separate document or can be in an expanded covering letter.

When is an Application Overview required?

An Application Overview is required for all product applications except for:

  1. Applications processed via the Admin Stream.
  2. Applications for Parallel Permits.
  3. Applications for Administrative Trials Permits

What information should the Application Overview include?

The Application Overview should address the points below. The bold text below gives suggested headings for the Application Overview, with the issues that should be considered detailed below each heading.

Reason for the application

The purpose of the application should be explained. For example, is it a new product, renewal, formulation change, additional use? Applications may be a combination of these.

The overview must include a summary of the proposed uses.

If there is a previous authorisation for the same product or a product from which extrapolation is sought, please give details of the authorisation. Please consider what assessment standards the previous authorisation was conducted to and whether these are still valid for the current application. This should in particular take account of the renewal status of the active substance(s) in the product.

Please highlight any changes that are sought in the new application compared to the current authorisation.

Please give details of any other issues that may affect your application.

The zonal context of the application (Northern Ireland only)

Applications for new, continuing or changed authorisations in Northern Ireland must follow the EU zonal process. In these instances, please highlight who the zonal RMS is and what national specific assessments you have presented to support the proposed NI authorisation.

Data access

Please explain the data ownership of the active substance and product data, including any reference products (where known). Please ensure that appropriate letters of access are included in your submission or that you reference where these were previously submitted or will be submitted by the data owner. If you are referencing product data which you believe is no longer protected, please note that only one reference product is allowed.

Please ensure that the basis for access to any task force data is fully explained. Please provide evidence of the task force's arrangements in respect of data access, making sure it is clear whether individual members of the task force can give access to 3rd parties, or whether the task force itself must agree to such access.

Summary of the Risk Assessment Approach

Please briefly summarise how the application addresses each area of the risk assessment (ideally under the sub-headings given below). This should not reiterate the information in the dRR but should indicate the approach to each area of the assessment. For example,  whether new data or modelling are supplied, or whether there are reasoned case(s), case(s) for extrapolation from other products or uses. If you believe that no assessment is required in a particular risk assessment area, please indicate why.

If extrapolation from other products is proposed, please consider the assessment standards under which the reference products were assessed. If these were not assessed to current standards (eg using approved active substance end points, appropriate data requirements and using latest guidance), please explain why you consider it is appropriate to extrapolate from these products.

Please highlight whether there are any relevant considerations for the active substance. For example, is renewal of the active substance(s) likely in the near future, or is the approval subject to confirmatory data requirements? Please explain how these affect your application.

Please consider documentation relevant to the approval of the active substance(s) in your product and address any pertinent points. MS issues and open points in the EFSA conclusion for the active substance(s) may remain relevant to your product assessment. Ensure that you address these as appropriate.

Active substance technical specification

Indicate whether or not you are seeking changes to any of the sources of active substance.

If you are seeking changes, please provide separate technical specification information as provided for in the guidance on technical specifications.

If no changes to the active substance source(s) is required, then please ensure that the technical specification reference information on the application form is correct.

Formulation details and physical and chemical properties

Formulation recipes must be presented in the form indicated in the application form, ie including the chemical name, CAS number (or other), trade name and the amount. For liquid formulations, the units must be expressed in g/L, and for solid formulations the units must be expressed as g/kg.

Indicate whether or not the application includes changes to the existing authorised formulation (including co-formulant name changes).

If a formulation change is proposed, then please ensure that Part C of the dRR includes a tabulated comparison of the (existing) authorised formulation and the proposed formulation.

If changes are included, then detail how these are being addressed (eg new data/cases).

If supporting data were generated on another formulation, then please ensure that Part C of the dRR includes a tabulated comparison of the authorised formulation (or formulation on which the supporting data were generated) and the proposed formulation.

Please ensure that the formulation details in the application form are the same as in Part C of the dRR.

Packaging

Highlight whether there are any changes to the existing packaging and if so, how these are being supported.

Please check the packaging details on the application form and within the dRR are the same.

For layered packaging materials, please make it clear which layer is in contact with the product (the inner/barrier layer), and name the layer materials in order from the inside to the outside.

Classification and labelling

Please highlight whether there is a proposed change in classification. If a new formulation consideration is required (eg new product, changed formulation) please set out the basis for the proposed classification. All products must be classified and labelled in accordance with the CLP Regulation (Regulation On Classification, Labelling and Packaging of Substances and Mixtures, 1272/2008). Further details are given in 'Introduction to Classification and Labelling for PPP's'. The labelling handbook details the general labelling requirements for all products.

Please ensure that all Safety Data Sheets (SDS) for the co-formulants in your product are in English and less than 2 years old (see common omissions checklists). If it is not possible to obtain an SDS less than 2 years old, please detail this in the application overview and provide evidence from the supplier that this is the most recent SDS and is an accurate description of the current classification.

Methods of analysis

Are you providing new methods? If yes please indicate which area(s) of the assessment these support (eg technical specification, formulation, fate and behaviour or residues).

Mammalian toxicology

Please identify whether or not any assessment is required and why.

Is any consideration required with respect to a new source of active substance?

Highlight how you are supporting the product classification (eg by calculation or data).

Identify how your proposed dermal absorption values are supported (eg new data, extrapolated from another formulation or default values).

If you are proposing changes to any toxicology endpoints, please ensure you highlight why this is essential and how you are supporting them.

Non-dietary exposure

Please identify whether or not any assessment is required and why.

If assessment is required, please indicate whether this is via new modelling, data or case.

Please highlight any specific concerns with respect to this area of the assessment.

Residues/consumers

Please identify whether or not any assessment is required and why.

If assessment is required, please indicate whether this is via new data or extrapolation from existing assessments.

If an assessment is required, please indicate whether or not you consider the current MRL accommodates the proposed use(s).

Fate and behaviour in the environment

Is any new F&B assessment required?. Please indicate why, and if it is, stipulate how this is being supported (eg reasoned case, new modelling, new data).

Ecotoxicology/effects on non-target species

Please identify whether or not any assessment is required and why. If it is, please explain how this is being supported (eg reasoned case, new data).

Efficacy

Please indicate whether the application includes changes to the current formulation and/or label. Please briefly summarise how you are supporting these changes.

Label

Please indicate if a new label is submitted. A draft label should be submitted as an individual document and not as part of another document.

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Updated 2021-08-10