Pesticide product application process

Pre-submission meeting

We recommend having a pre-submission meeting with us before you submit a new application for an active substance or pesticide product.

The meeting can be about a single product or several related products.

The main aims of the meeting are to:

• answer any procedural questions
• reach an understanding of the guidance that will or could apply to the submission
• consider any potential issues that may arise during evaluation
• consider, if relevant to the application, MRLs and answer any questions on the GB MRLs application process.
• establish a projected timetable for submission

HSE charges a fee for the meeting.

You can arrange a pre-submission meeting using form CRD10.

You can also arrange a meeting in the same way where substantial specialist advice is needed to discuss a problematic issue during an existing application.

Processing times

The processing times are related to those defined in Regulation 1107/2009 as it applies in Great Britain and Northern Ireland

Processing timelines for pesticide product applications.

If your application is accepted you will be informed of the stream into which it has been placed and the processing target for its completion (calculated from the date of acceptance). Purely administrative applications will be processed within 6 weeks.

New active substance and active substance renewal applications will be checked for admissibility before they are accepted for assessment. The assessment target will be measured from the date the application is accepted as admissible.

If we need to contact you during the evaluation to request further information, the target date for the completion of your application may be adjusted to take into account the time taken for you to respond and you will be informed of the revised target date.

Cost

Find out about the application and evaluation fees for applications.

How to submit your application

Submit your application and requests for a ShareFile link via email to our applications team [email protected].

Or post to:

Pesticides Product Team Applications Sift
Chemicals Regulation Division
Mallard House
Kings Pool
3 Peasholme Green
York
YO1 7PX

Documentation

Find out what documents you will need to provide with your application and a checklist.

Save the individual components of the application as separate electronic files and identify them clearly using the following naming conventions:

Application documents: naming conventions

Maximum email size and zip files

If your email exceeds 25Mb it will be refused by the HSE mailing system. Also, you may not be able to submit an email with a lot of attachments.

If your application exceeds these limits, we can accept a 'zipped' application. Alternatively, you can send the information using ShareFile in the same format, together with the covering letter.

How we sift your application

We consider applications at an 'applications sift' which usually takes place every Tuesday. At the sift we will determine if your application is acceptable as well as the appropriate processing stream and fee for your application.

Application sift

The application sift consists of 2 stages:

1. Validation check

When we receive your application, we will make an initial assessment of the information to determine if the submission is complete.

We charge a fee for this step whether the application is accepted or not. If the submission is incomplete it will be rejected and the application closed. You will need to submit any subsequent application in full and we will allocate a new application (COP) number.

Applications rejected at this stage are likely to be incomplete or missing part of the required documentation.

For applications requiring no technical input, the detailed technical sift and evaluation stage are not applicable.

Following the validation check, applications requiring a technical input will be streamed appropriately to either directly enter the evaluation stage or to be considered by the detailed technical sift. The latter applies to the types of application listed below (detailed technical sift).

2. Detailed technical sift

If we accept the application following the validation check it will undergo a detailed sift, where required, to ensure that the application is of sufficient quality to undergo a full evaluation.

We charge a fee for this step.

Applications requiring a detailed technical sift are:

• assessments for new products supported by data and other applications where data consideration is required in most risk assessment areas
• applications where a product or use has previously been refused and is contentious
• applications for which Northern Ireland is a concerned member state
• all requests for assessment of technical equivalence of new sources of active substances

The detailed technical sift is necessary to ensure the product dossier supports the proposed uses and where necessary issues identified are communicated to applicants. Potential reasons for rejection at this stage include:

• poor application overview that does not clearly define how each area of the risk assessment is being supported (for example new data, reference to previous evaluations, data considered for the approval/renewal of the active)
• incorrect data access
• inconsistent GAP within application
• use of incorrect endpoints
• use of incorrect article
• the presence or absence of information prevents a regulatory decision being made
• poor presentation of supporting information such that it is not possible to proceed with the assessment

The criteria applied in each specialist area for the detailed technical sift are outlined in The Detailed Technical Sift and this document includes additional explanation. This has been provided to assist in understanding what key information is required in each specialist area. Applications will be assessed against these criteria, but the list is not exhaustive, and the product dossiers must comply with the requirements of Regulation (EC) 1107/2009.

If the application fails the detailed technical sift, will reject and close it, giving full details of the reasons for rejection. At this point, you will not be able to provide the missing information to complete the original application; instead, you will need to submit a new application. If your application is rejected at the validation step, you must submit any subsequent application in full and we will issue a new application (COP) number.

Passing the detailed technical sift does not guarantee that your application will result in an authorisation.

The detailed technical sift in most cases will be completed within 4 weeks of receiving your application at HSE's weekly application sift.

Note:

We require an application overview for all the types of applications that will be considered in the detailed sift. The overview greatly aids the sifting of the application as it briefly summarises what the request is and how it is supported.

To ensure your application is considered at the Tuesday sift we must receive it in full (including associated data whether by email, hard copy, on CD or submitted via ShareFile) either via email or as a hard copy by 18:00 on the previous Tuesday.

Notification of outcome of the sift

We will:

• inform you of the outcome of the decision made by the sift
• inform you of the processing stream and target for your application
• send you an invoice for the application fee

We will also inform you of a unique identification number for your application (the 'COP number') and you should always quote this when contacting us to discuss your application.

Notification of outcome of the admissibility check for active substance applications

Applications for active substances approval and renewal of approval undergo an admissibility check, which is a detailed examination to determine if the application is complete and can be accepted for full assessment. We will invoice you for the admissibility check once we receive your application.

For new active substances, we will complete the admissibility check within a maximum of 45 days of receipt of your application, extended by up to 3 months if we request further information. For renewal of approval of active substances, we will complete the admissibility check within a maximum of 30 days, extended by up to 14 days if we request further information.

We will inform you if further information is required with a deadline for submission and whether your application is admissible.

If we consider your application to be admissible, we will send you another invoice for the full assessment of your application and inform you of the processing target and the unique COP number. We will then start the assessment process for your application.

If we do not consider your application to be admissible, or we do not receive further information by the informed deadline, we will reject your application.

Evaluation start date and progress

We will place accepted product applications into the appropriate stream and will start in queue date order. The assessment manager assigned to deal with it will inform you once the application is started. This is with the exception of 'admin stream’ applications, as the short processing time for these applications makes this impractical.

If your application is for a new active substance or active substance renewal, the assessment manager will inform you of the start date. They will also keep you informed of progress with your application and the intended meeting dates for the GB regulatory bodies when they are known.

As indicated above you will be informed when your application is accepted and then started unless your application is accepted into the admin stream. The introductory letter will give details of the assessment manager for your application who you can contact for updates on the progress of your evaluation.

During the evaluation, if we need to contact you to clarify areas of the risk assessment we will inform you of the revised processing target for your application once we receive your response.

If we need to seek information or documents from a third party in order for the application to proceed, we will suspend your application until we receive the information. We will inform you when we suspend the application. When we receive the information, we will inform you of the revised target date for completion.

Where a commenting period applies, we will send you a copy of the draft registration report (non-confidential sections only) containing the draft authorisation and draft label amendments. A deadline will be set for you to inform HSE of any comments, corrections or issues.

We will inform you when we have completed the evaluation of your application. If an authorisation is to be issued, we will inform you by letter or email.

If we refuse your application, we will send you a letter fully explaining the reasons for the refusal.

If you wish to discuss your application, you should contact the assessment manager in the first instance.

Informing you if additional information is required

During the evaluation of your application we may need to request:

• additional information
• reasoned scientific cases
• data

We may request this as soon as we start your application or after we have completed its initial evaluation.

It will be HSE's responsibility to ensure that the request covers all of the issues for that area of the risk assessment.

We will inform you what additional information is required by letter or email along with a target date for responding with the additional information. If you do not respond within this time, we will complete the application as fully as possible. In some cases this may result in your application being refused. Any time lapsing between us requesting information and receipt of your reply will be added to the processing target for the application.

If you cannot provide the required information within the deadline you should contact the assessment manager as soon as you are aware of this, indicating the reasons for the delay. We may be able to arrange a revised deadline for the receipt of the required information. However, these extensions are considered on a case-by-case basis and are at our discretion. If our request is not clear, or you are unsure of the reason for it, contact us at an early stage to discuss the issues before responding to the request. If there is an omission on our part, or where an additional requirement becomes apparent following a different specialist evaluation, we will allow the issue to be addressed.

In most cases we will be asking for clarification of the data or reasoned scientific cases already submitted. However, on some occasions we may ask you for new data or reasoned scientific cases that did not form part of the original application.

We will accept new data and/or reasoned cases 'mid-evaluation', but we will charge you an additional fee to cover the cost of the additional work. We will adjust the processing target by the time taken for you to provide a full response to the letter.

Submitting additional data and information during a pesticide evaluation.

Adding more information to your application

You may wish to provide additional data or information before we complete the evaluation of your application. Providing it does not extend the scope of the original application, we may be able to consider the additional data or information without needing to charge an additional fee or extending the processing target for the application. However, you will only be able to make certain alterations in this way. If you wish to provide additional data or information in support of your application, contact the assessment manager at the earliest opportunity. We consider these requests on a case-by-case basis and are at our discretion.

More on changing a pesticide product application mid-evaluation.

Withdrawing your application

You can withdraw your application at any time by contacting the assessment manager for the application.

If your application is administrative, email [email protected].

Or write to:

Pesticides Product Team Applications Sift
Chemicals Regulation Division
Mallard House
Kings Pool
3 Peasholme Green
York
YO1 7PX