The Applicant Guide: What Should I Include In An Application?
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
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.
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:
- The purpose of the application eg to obtain authorisation for a new use; to meet outstanding data requirements; to add an adjuvant to the Official List; to gain a parallel trade permit for an imported product.
- The type of authorisation/permit you are requesting eg application for standard authorisation; mutual recognition ; Extension of authorisation for a minor use etc;
- Whether the application is to be UK only or zonal.
- Whether the application is to be considered as a fast-track.
- Brief details as to how you are supporting your application eg on the basis of similarity to another product; on the basis of unprotected data; via submission of data.
- A statement to indicate if a comparative assessment is needed.
- If there has been correspondence with HSE prior to submitting the application the covering letter should include brief details and the name of the person the correspondence was with. The full correspondence can be attached as an appendix.
- It would be helpful if a list of documents submitted is included together with where they are located/ labelled on the CD as appropriate.
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.
CRD1 New commercial authorisation, permit for trial purposes
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
CRD2 Administrative authorisation (not Extension of authorisation or Official Listing of Adjuvant)
CRD3 Extension of authorisation for a minor use of a plant protection product
CRD4 For applications for the inclusion of an adjuvant on the Official List
CRD5 and CRD6 (own use) For applications for a parallel trade permit of imported plant protection products
CRD7 For applications for Administrative Permit for trial purposes
CRD7 can be downloaded here in Word format.
Guidance on completing this form can be found within the form itself
CRD8 For applications to consider new or changes to the technical material
CRD9 For applications where an emergency use/ situation is required
CRD-R For applications to renew products after the renewal of an active substance
For applications to change EC MRLs or import tolerances
Oret 1 For applications for Official Recognition
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.
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:
- Reference to the current authorisation for your product (ie refer to the appropriate COP number) and any associated 'amendment' Notices
- Any other correspondence relating to your Notice of Authorisation eg letters confirming the acceptability of a change in manufacturing site.
- 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.
- Copies of correspondence which clarifies data requirements eg copies of correspondence on data requirements that must be addressed for your product.
- 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).
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:
- Applications for authorisation of a new product.
- 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.
- Applications for parallel trade permit
You do not need to provide copies of the draft product label for the following types of applications:
- Applications where there are no changes to the product label eg those addressing confirmatory data requirements.
- Applications which can be dealt with via the Admin Stream.
- 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 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:
- By submitting new data that are specific to the active substance(s), formulation(s) or use(s).
- By referencing data that have been previously evaluated in support of another product(s) that can be extrapolated to support your product.
- 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.
- By referencing unprotected data that have previously been evaluated in support of another product (see the guidance document on the protection of data).
- 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.
- 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.
- The contents page for The Applicant Guide
- UK Guidance for The Applicant Guide
- Do I need to submit an application?
- How will my application be processed?
- What happens once my application is completed?