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:
- An index of different application types to help you determine what you need to submit for different types of applications.
- A checklist to help ensure that your submission is complete is available.
- Links to application forms for different types of applications.
Where possible, send all applications electronically. You should include:
- the relevant application form
- covering letter
- all supporting documentation
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.
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:
- the purpose of the application. For example:
- to obtain authorisation for a new use
- to meet outstanding data requirements
- to add an adjuvant to the Official List
- the type of authorisation/permit you are requesting. For example:
- application for standard authorisation
- trials permit
- extension of authorisation for a minor use
- brief details as to how you are supporting your application. For example:
- 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 or ShareFile submission as appropriate
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
Administrative authorisation (not Extension of Authorisation for Minor Use or Official Listing of Adjuvant)
Extension of authorisation for a minor use of a plant protection product
For applications for the inclusion of an adjuvant on the Official List
Northern Ireland only
Obtain guidance from HSE
For applications for Administrative Permit for trial purposes
In the form
For applications to consider new or changes to the technical material
In the Applicant Guide
For applications where an emergency use/ situation is required
In the form and in Emergency Authorisations
For applications to renew products after the renewal of an active substance
In the Applicant Guide
For applications for a pre submission meeting
In the form
For applications to change MRLs or import tolerances
For applications for Official Recognition
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
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:
- Reference to the current authorisation for your product (for example refer to the appropriate COP number) and any associated 'amendment' Notices
- Any other correspondence relating to your Notice of Authorisation. For example 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. For example 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. For example 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 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).
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:
- Applications for authorisation of a new product.
- Applications for changes to an existing product authorisation where changes are required to the label text. For example for authorisation of the product on new crops or in new situations.
- Applications for Northern Ireland only 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. For example 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. 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 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:
- 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 (go to the guidance on the protection of data - extrapolated and assessed trials permits).
- 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, 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.