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The Applicant Guide: What should I include in an application?

There are general documentation requirements that you must submit with every application. In addition, there may be specific documentation requirements depending on the type of application. This section describes the general documentation you must provide. Links to additional advice are given in the bullets below:

Where possible, send all applications electronically. You should include:

Email to: [email protected].

If it’s too large to email, use our applications file transfer system, ShareFile, to upload all documentation, preferably in zip file format. ShareFile is a cloud-based system with built in encryption enabling secure transfer of large submissions up to 100GB. Email requests for ShareFile links to [email protected].

Priority will be given to applications submitted electronically. Applications not submitted electronically may take longer to process.

General documentation

The covering letter

You must submit a covering letter for each application to help us understand why you have submitted your application. Your letter must include:

You may expand this information to provide details of how you are addressing each area of the assessment or submit an 'Application Overview'.

The application form

You must complete an appropriate application form for every application you submit.

There are different application forms depending on the application type.

Application forms for different application types

All application forms are in the Microsoft Open XML (.docx) format unless otherwise stated.

Type of application Application form required Where can I get guidance on completing this form?

New commercial authorisation, permit for trial purposes

CRD1

No additional guidance other than instructions in form. Use the Applicant Guide for specific issues or contact HSE

Administrative authorisation (not Extension of Authorisation for Minor Use or Official Listing of Adjuvant)

CRD2

No additional guidance other than instructions in form. Use the Applicant Guide for specific issues or contact HSE

Extension of authorisation for a minor use of a plant protection product

CRD3

No additional guidance other than instructions in form. Use the Applicant Guide for specific issues or contact HSE

For applications for the inclusion of an adjuvant on the Official List

CRD4

No additional guidance other than instructions in form. Use the Applicant Guide for specific issues or contact HSE

Northern Ireland only
For applications for a parallel trade permit of imported plant protection products

CRD5
CRD6

Obtain guidance from HSE

For applications for Administrative Permit for trial purposes

CRD7

In the form

For applications to consider new or changes to the technical material

CRD8

In the Applicant Guide

For applications where an emergency use/ situation is required

CRD9

In the form and in Emergency Authorisations

For applications to renew products after the renewal of an active substance

CRD-R

In the Applicant Guide

For applications for a pre submission meeting

CRD10

In the form

For applications to change MRLs or import tolerances

Application form

Website guidance

For applications for Official Recognition

Oret1

Notes for guidance

Application forms are not required when requesting import tolerances or certificates of free-sale.

Technical specification and formulation details

For most applications it is important that we have full details of the technical specification and formulation recipe. Further advice on how to present this information is in the guidance on technical specifications and formulation details

Application Overview

The Application Overview allows you to present the data and/or information that have been submitted in support of your application and discuss how each area of the risk assessment is to be addressed.

An Application Overview is not required if your application will be processed via the Admin Stream, or an Administrative Permit for trial purposes.

Information is provided in the guidance on completing an Application Overview to help ensure you address all the areas of the risk assessment.

Draft registration report

For applications for new products, amendments to existing products and renewals, you should supply a draft Registration Report (dRR). Use these dRR templates to help you.

Please note that the dRR and the application overview perform different functions. If you submit a dRR with your application, we request that you additionally include a simple application overview highlighting the general approach to be taken with your application. This should set out data ownership/access and clearly summarise how each area of the assessment is supported. If the application relies on previous risk assessments, please make clear reference to when and where these assessments were undertaken.

Previous relevant correspondence

You must submit, or refer to, copies of any previous relevant correspondence relating to your application so that all supporting information is available, or can be traced, by the Assessment Manager. Relevant correspondence can consist of letters or emails and may include the following:

Letters of access

If you are not submitting your own data or referencing unprotected data (see the guidance on the protection of data) you will need to provide a letter from the appropriate data owner which allows access to their data. A letter of access is also required for applications for Extension of Authorisation for a Minor Use.

Letters are required to cover all the data used to support your product/Extension of Authorisation for a Minor Use, not just the data submitted in support of a specific application. You can find further information in the guidance on letters of access.

Where you are referencing a previously submitted letter of access, give details of the date the letter was submitted and for which product/application (refer to the appropriate COP number if known).

Product labels

For most applications you must provide a copy of the draft label. The draft label and any amendments will form part of the product authorisation. Further information on producing labels can be found in The Labelling Handbook.

You must provide 1 copy of the draft product label for the following types of application:

You do not need to provide copies of the draft product label for the following types of applications:

  1. Applications where there are no changes to the product label. For example those addressing confirmatory data requirements.
  2. Applications which can be dealt with via the Admin Stream.
  3. Applications where simple changes to the label could be incorporated using a label amendment. For example removal of a statutory restriction.

Where you do not submit a draft label, you must provide a suitable reference to the previously authorised label (including COP number under which the product label was submitted, and the document reference specified on your current authorisation).

Data

Data and information submitted in support of the approval of a new active substance in Great Britain (GB), or in support of the review of an active substance in GB, must be submitted in the format of an 'OECD dossier'.

For all other applications (product) there are several ways in which you can address the appropriate requirements:

For all applications you must provide a summary of the submitted data and an assessment as to how these data support the proposed product and use(s). This summary can be in the format of a summary dossier or Application Overview.

A copy of all the data referenced in support of your application must be submitted (single paper copy, CD/Email or ShareFile submission containing all of the studies). All studies must be in English and must be generated in line with relevant international test guidelines and the applicable requirements for Good Laboratory Practice (GLP) compliance or Official Recognition.

Data may be submitted in an electronic format. The CADDY system may be used if preferred. This system allows for the submission of study reports as image files and the summary dossier as Word or spreadsheet files.

For product applications see The Data Requirements section of this website.

Do I need to submit everything before my application is accepted?

We will not accept incomplete applications.

The only exception to this is if a letter of access from a third party is to be submitted separately. This does not apply to applications processed via the Admin Stream.

Further information

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Updated 2021-01-14