There are general documentation requirements that you will need to submit with your application and that are common to all application types. In addition, there may be specific documentation requirements depending on the type of application. This section describes the general documentation you will need to provide with most applications.
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 as identified by common omissions from applications.
Links to application forms for different types of applications.
General documentation
The covering letter
You should submit a covering letter for each application. This is an important document since it helps us understand why you have submitted your application. Your letter should detail:
- The purpose of the application e.g. 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 e.g. application for full approval under the transitional arrangements; provisional approval under Regulation (EC) No 1107/2009; mutual recognition ; Extension of authorisation for a minor use; or whether the application is to be considered as a fast-track.
- Brief details as to how you are supporting your application e.g. on the basis of similarity to another product; on the basis of unprotected data; via submission of data
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? |
| Commercial authorisation or permit for trial purposes (not parallel trade permits) where a technical assessment (data and/or reasoned cases) is required (No-Data, Data or Data-Plus Streams). | 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 at applicant-enquiries@hse.gsi.gov.uk |
| Administrative Stream authorisation (not Extension of authorisation or Official Listing of Adjuvant) | CRD2 | CRD2 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 at applicant-enquiries@hse.gsi.gov.uk |
| Extension of authorisation for a minor use of a plant protection product | CRD3 | CRD3 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 at applicant-enquiries@hse.gsi.gov.uk |
| For applications for the inclusion of an adjuvant on the Official List | CRD4 | CRD4 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 at applicant-enquiries@hse.gsi.gov.uk |
| 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 change EC MRLs or import tolerances | | Application form for MRL setting(Word file) | Guidanceon 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. |
Paper copies of all the application forms can be obtained from:
Approvals Support Group, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX, UK and on 01904 455966 (International: (+44 1904 455966), 01904 455722 (fax) (International (+44) 1904 455722) or applicant-enquiries@hse.gsi.gov.uk.
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, either in full or via a reference to where this information has been previously submitted. 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.
For straightforward applications, you may choose to expand your covering letter instead. 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.
The Application Overview is a useful document which we encourage applicants to use. Information in the guidance on completing an Application Overview is provided to help ensure you address all the areas of the risk assessment..
Draft registration report
For most applications for new products, amendments to existing products and re-registration, you should supply a draft Registration Report 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 (or detail within your covering letter) 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, i.e. by new data, a reasoned case, reference to previous evaluations, or highlight that no assessment is required. If the application relies on previous risk assessments, please make clear reference to when and where these assessments were undertaken..
Previous relevant correspondence
You should 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 (i.e. refer to the appropriate COP number) and any associated ‘amendment’ Notices
- Any other correspondence relating to your Notice of Approval e.g. 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 e.g. 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 e.g. copies of correspondence on data requirements that need to 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 document 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 document 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 will need to provide a copy of draft label which will be considered during the evaluation of your application. The draft label and any amendments will ultimately form part of the product authorisation. Further information on producing labels can be found in The Labelling Handbook.
You will need to 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 e.g. for authorisation of the product on new crops or in new situations; for authorisation of the product to control new pests, diseases or weeds.
- Re-registration
- 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 e.g. those addressing confirmatory data requirements; those for minor changes to the formulation.
- Applications which can be dealt with via the Admin Stream.
- Applications where simple changes to the label could be incorporated using a label amendment e.g. removal of a statutory restriction; change in product classification. You must detail the required change in your covering letter.
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 a ‘OECD dossier’
For all other applications (product) there are several ways in which you can address the appropriate requirements, for example:
- 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 should 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. Please contact us at the Applicants email address if you require further information.
For product applications processed by Pesticide Branch, the data requirements are can be found in The Data Requirements Handbook.
Do I need to submit everything before my application is accepted?
To ensure that all the relevant information is available to allow us to evaluate your application, we will generally not accept applications we know to be incomplete. The only exceptions to this are:
- If the application is a two-stage application (see The Applicant Guide).
- 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.
We will consider any requests for accepting applications where there are minor deficiencies on a case by case basis, e.g. where a study is nearing completion in a discrete area of the assessment and all other studies for this area have been submitted. To allow us to consider such requests you should provide a clear indication of when the outstanding information will be available. We will process the application as far as possible and then contact you if the outstanding information has not yet been submitted. You should note that this approach may delay the completion of your application and in some cases may result in your application being refused.
