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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) replaces the previous need for a detailed Application Overview, but a summary Application Overview putting the application into a zonal and UK context, is still required.

The Application Overview may be presented as a separate document or the relevant issues can be addressed 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 Experimental Approvals.

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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, re-registration, formulation change, additional use. (Many applications are a combination of these for example a re-registration in the UK but a new product in another concerned Member State).

The overview must include a summary of the proposed uses. This must explain whether you are requesting CRD to undertake an assessment of uses for which authorisation is not sought in the UK, and detail what these uses are (if you request non-UK uses a surcharge will be applied to your application as detailed in The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009.

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 recent active substance approvals (previously Annex I inclusions) or renewal of approvals.

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

Applications received after 14th June 2011 must be considered in relation to the zonal procedures described by Regulation 1107/2009. So that CRD can process your application appropriately, please ensure that the following is addressed in your Application Overview.

For new products and re-registrations; has the zonal RMS already been agreed? Which country is the zRMS and which are the concerned Member States? Such agreement should be sought in the pre-submission period as detailed in The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009. (Acceptance of your application will be delayed if this is not agreed prior to submission).

If the UK is the zRMS do you wish CRD to conduct an assessment of the non-UK elements of the core dossier (eg German operator exposure model and groundwater assessments for scenarios not relevant to the UK)? If so an additional partial dossier fee will apply as detailed in The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009. Please confirm that you accept that this fee applies, or provide a reasoned argument that this fee should not apply (for example your company has recently had a zonal surcharge applied to a similar product (same active combinations) for the same uses).

If you confirm that a UK assessment only is required, we would conduct a Uniform Principles assessment in line with UK requirements only. You should highlight this to any concerned Member States, if you subsequently seek an authorisation based on Mutual Recognition of the UK authorisation. (A zonal surcharge would usually not apply).

Data access

Please explain the data ownership of the Annex II and Annex III 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 Annex III 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 summarise the approach to each area of the assessment (eg specifically indicating whether new data are supplied, new modelling, reasoned case(s), case(s) for extrapolation from other products, or reasoning why no assessment is required).

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 end points as agreed in the EC review process), please explain why you consider it is appropriate to extrapolate from these products.

Please highlight whether the active substance approval is subject to confirmatory data requirements and explain how this affects your application. Have the data been submitted to the RMS, and if so when is the assessment expected. Please note that CRD assesses active substance confirmatory data requirements by way of a specific application and confirmatory data should not be presented solely as part of a product application.

Please consider any open points in the EFSA conclusion for the active substance(s) in your product and ensure that you address these in your submission.

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 UK 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.

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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 (EC Regulation On Classification, Labelling and Packaging of Substances and Mixtures, EC 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 accordance Material Safety Data Sheets (MSDS) for the co-formulants in your product are in English, in EU format and less than 2 years old (see common omissions checklists). If it is not possible to obtain an MSDS less than 2 years old and in EU format, please detail this in the application overview and provide evidence from the supplier that this is the most recent MSDS 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 end-points, please ensure you highlight why this is essential and how you are supporting them.

Operator, Bystander and Worker 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 and why. If it is please indicate how this is being supported (eg reasoned case, new modelling, new data).

Ecotoxicology/ Effects on Non-Target Species

Is any new Ecotoxicology assessment required and why. If it is please indicate 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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Further information

Updated 2016-11-07