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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. In addition supplementary advice is given at the 3 links below:

An index of different application types to help you determine what you need to submit for different types of applications.

A checklist to help with ensuring that your submission is complete is available.

Links to application forms for different types of applications.

General documentation

The covering letter

You must submit a covering letter for each application. This helps 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. Alternatively you may 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
Type of application Application form required Where can I get this form from? Where can I get guidance on completing this form?

New commercial authorisation, permit for trial purposes

CRD1

CRD1 can be downloaded here in Word format

There is no additional guidance other than instructions in the form itself. You should use guidance in the Applicant Guide for specific issues or contact CRD

Administrative authorisation (not Extension of authorisation or Official Listing of Adjuvant)

CRD2

CRD2 can be downloaded here in Word format.

See line above

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

CRD3

CRD3 can be downloaded here in Word format.

See line above.

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

CRD4

CRD4 can be downloaded here in Word format.

See line above

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

CRD5

CRD6

(own use)

CRD5 can be downloaded here in Word format CRD6 (own use) can be downloaded here in Word format

Guidance on completing these forms can be obtained from CRD

For applications for Administrative Permit for trial purposes

CRD7

CRD7 can be downloaded here in Word format.

Guidance on completing this form can be found within the form itself

For applications to consider new or changes to the technical material

CRD8

CRD8 can be downloaded here in Word format.

Guidance on completing this form can be found on this website, see Applicant Guide

For applications where an emergency use/ situation is required

CRD9

CRD9 can be down loaded here in Word format Guidance on completing this form is found within its self and on this website, see Emergency Authorisations

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

CRD-R

CRD-R can be downloaded here in Word format.

Guidance on completing this form can be found on this website, see Applicant Guide

For applications to change EC MRLs or import tolerances

Application form (on Europa website) for MRL setting(Word file)

Guidance on completing this form can be found on this website

For applications for Official Recognition

Oret 1

This form can be downloaded in Adobe Acrobat (pdf ) or 'Word' format.

Guidance on completing this form can be found on this website as a pdf file or in 'Word' format.

For notifying zonal applications

Zonal Notification Form

Refer to 'Zonal Guidance' at the link below: Zonal authorisation procedure under Regulation (EC) 1107/2009

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 can be found in the guidance document 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 is for a parallel trade permit 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) as detailed in 'The Applicant Guide: Zonal authorisations and mutual recognition under Regulation (EC) 1107/2009'.

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 Evaluating Officer or Project Manager. Relevant correspondence can consist of letters or emails and may include the following:

  1. Reference to the current authorisation for your product (ie refer to the appropriate COP number) and any associated 'amendment' Notices
  2. Any other correspondence relating to your Notice of Authorisation eg letters confirming the acceptability of a change in manufacturing site.
  3. Reference to the current authorisations(s) for other product(s) that you are referencing in support of your application eg for new products based on similarity to products that are already authorised; for applications for authorisation of a source of an active substance already authorised in another product.
  4. Copies of correspondence which clarifies data requirements eg copies of correspondence on data requirements that must be addressed for your product.
  5. Other advice we have provided you with that relates to your application.

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, not just the data submitted in support of a specific application. Further information on letters of access can be found in the guidance on letters of access.

Where you are referencing a previously submitted letter of access then provide 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 one copy of the draft product label for the following types of application:

  1. Applications for authorisation of a new product.
  2. Applications for changes to an existing product authorisation where changes are required to the label text eg for authorisation of the product on new crops or in new situations.
  3. Renewals
  4. Applications for parallel trade permit

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 eg 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 eg 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 EU Reviews or new active substances 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,  eg:

  1. By submitting new data that are specific to the active substance(s), formulation(s) or use(s).
  2. By referencing data that have been previously evaluated in support of another product(s) that can be extrapolated to support your product.
  3. By submitting a letter authorising us to access data submitted by a third party that are either submitted in support of your application or previously evaluated in support of another product.
  4. By referencing unprotected data that have previously been evaluated in support of another product (see the guidance document on the protection of data).
  5. By submitting published studies, or other information, from scientific journals or other sources. The full report on which the published study is based should be provided if it is available.
  6. By submitting a reasoned scientific case as to why certain data requirements do not need to be met by the provision of actual data.

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 or CD/Email 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 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

Updated 2017-01-04