Documents and information needed for a pesticide application

About this guide

This page provides guidance on the documents and information you may need to provide with your application for a plant protection product (referred to as a pesticide product).

To find out what you will need to include in your application go to the list of application types or our page on how to place a pesticide product on the UK market.

Covering letter

You must submit a covering letter 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 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
• a list of documents submitted together with where they are located/ labelled on the ShareFile submission

You may expand this information to provide details of how you are addressing each area of the assessment in an 'application overview'.

Application form

You must submit the appropriate form with your application.

You do not need to submit an application form when requesting certificates of free-sale.

Pesticide application forms.

Technical specification and formulation details

For most applications it is important that you give full details of the technical specification and formulation recipe.

Find out more about:

• technical specification
• formulation details

Application overview

You must submit an application overview as a separate document for all product applications except for applications:

• processed via the admin stream
• for parallel permits
• for administrative trials permits

The application overview allows you to:

• present the data and information that you have submitted to support your application
• explain how you are addressing each area of the risk assessment

More on completing the application overview.

Draft registration report

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

The dRR and the application overview perform different functions.

Use these templates to submit your dRR.

Previous relevant correspondence

You must submit, or refer to, copies of any previous relevant correspondence relating to your application. This is 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 authorisation(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 you are referencing protected data you will need to provide a letter from the appropriate data owner which allows access to their data.

More on the protection of data.

A letter of access is also required for applications for extension of authorisation for a minor use (EAMU).

You must provide letters to cover all the data used to support your product, not just the data submitted in support of a specific EAMU application.

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

More on letters of access.

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 a copy of the draft product label with the following applications for:

• authorisation of a new product
• 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
• renewals
• Northern Ireland only parallel trade permit

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

• where there are no changes to the product label - for example those addressing confirmatory data requirements
• administrative 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. Include the COP number under which the product label was submitted, and the document reference specified on your current authorisation.

Data and studies

For product applications, you can address the appropriate data requirements by:

• submitting new data that are specific to the active substance(s), formulation(s) or use(s)
• referencing data that have been previously evaluated in support of another product(s) that can be extrapolated to support your product
• submitting a letter authorising HSE 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
• referencing unprotected data that have previously been evaluated in support of another product - go to guidance on the protection of data
• submitting published studies, or other information, from scientific journals or other sources – if available, provide the full report on which the published study is based
• 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 in the dRR and an assessment as to how these data support the proposed product and use(s).

You must submit a copy of all the data referenced in support of your application. This can be via a ShareFile submission containing all 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.

If preferred, you can use the CADDY system. This system allows you to submit study reports as image files and the summary dossier as Word or spreadsheet files.

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'.

• Guidance on fulfilling data requirements.
• Data requirements for continuing pesticide product authorisation

Before you submit your application

To help ensure that the application submission is complete, you can use the checklist for pesticide product applications.

We will not accept incomplete applications. The only exception to this is when a letter of access is to be submitted separately by a third party. This exception does not apply to administrative applications which must always be supported by a letter of access at the time of application.