The Applicant Guide: How Will My Application Be Processed?
How long will it take to get my authorisation and what are 'streams'?
The processing times are related to those defined in Regulation 1107/2009 as it applies in Great Britain and Northern Ireland.
Full details of the application streams and processing targets can be found in the guidance on application streams and targets.
When 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) unless your application is accepted in the Admin Stream'.
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.
How much will my application cost?
There is a charge for the processing of all applications except for:
- Statutory extensions of use (See the guidance for extensions of use for further information)
- The inclusion of adjuvants on the Official List
- The production of certificates of free‑sale
- The consideration of adverse data
For applications for Administrative Trial Permits HSE will issue new permits within 5 days of the date of acceptance of the application, to avoid undue delay for the applicant. Outstanding payments will be pursued by HSE and non-payment could result in withdrawal of the permit (see the guidance document for Trials permits).
No refund is made if the application is refused. See the guidance for full details of the application fees and how to pay them.
Where do I submit my application?
Applications for commercial authorisations and trials permits, extensions of authorisation for minor use, import tolerances and for the inclusion of adjuvants on the Official List should be submitted using the existing application forms. Individual components of the application should be saved as separate electronic files, and be clearly identified using the following naming conventions:
Application Documents: Naming Conventions
|Standard Name||Content of Document|
|LETTER||The covering letter should detail the context and type of application. This should include an NPE statement where required, reference to letters of access and a list of enclosures.|
|FORM||The application form should include details of the formulation, technical specification and data lists as appropriate|
|OVERVIEW||Details of how to put together an application overview are given in the Applicant Guide - what to include|
|DATA - (summary of study subject area)||These should be titled 'DATA' followed by a few words to summarise the subject area|
|LABEL||Where applicable a copy of the draft product label should be included with your application. Further details on submitting a label are given in the Applicant Guide - what to include|
|OTHER - (brief description)||Other information such as previous correspondence should be titled 'OTHER' followed by a few words describing the document|
Maximum Email Size and Zip Files
Emails which exceed 25 Mb will be refused by the HSE mailing system. In addition, an email may not be submitted with a large number of attachments.
If your application exceeds these limits, we would be able to accept a 'zipped' application. Alternatively, we would be happy to receive the information via ShareFile in the same format, together with the covering letter.
Further details of the documentation requirements for most applications is given in The Applicant Guide - what to include.
Applications and requests for a ShareFile link must be emailed to [email protected] or sent to Pesticides Delivery Branch Applications Sift, Chemicals Regulation Division, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX.
What happens after I submit my application?
Applications are considered 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.
The application sift consists of two stages:
1. Validation check
When HSE receives the application, an initial assessment of the information will be made to determine if the submission is complete.
A fee is charged for this step whether the application is accepted or not. If the submission is regarded as incomplete it will be rejected and the application closed. Any subsequent application will need to be submitted in full and will be allocated a new application (COP) number.
Applications rejected at this stage are likely to be incomplete or missing part of the required documentation.
For administrative 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 (see detailed technical sift).
2. Detailed technical sift
If the application is accepted 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.
A fee is charged for this step.
Applications requiring a detailed technical sift are currently:
- 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/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, it will be rejected and closed, with full details of the reasons for rejection being provided. There will be no opportunity at this point to provide the missing information to complete the original application; instead, a new application will be required. For applications rejected at the validation step, any subsequent application must be submitted in full and a new application (COP) number will be allocated.
Passing the detailed technical sift does not guarantee that an application will result in an authorisation.
The detailed technical sift in most cases will be completed within 4 weeks of receiving the application at HSE's weekly application sift.
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, the processing stream and target for your application, and send you an invoice for the application fee. You will also be informed 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 your application is received.
For new active substances, the admissibility check will be completed within a maximum of 45 days of receipt of the application, extended by up to 3 months if further information is requested. For renewal of approval of active substances, the admissibility check will be completed within a maximum of 30 days, extended by up to 14 days if further information is requested.
We will inform you if further information is required with a deadline for submission and whether your application is admissible.
If your application is considered 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. The assessment process for your application will then commence.
If your application is not considered admissible, or we do not receive further information by the informed deadline, your application will be rejected.
When will my application be started?
Accepted product applications will be placed into the appropriate stream and started 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. The Assessment Manager will also keep you informed of progress with your application and the intended meeting dates for the GB regulatory bodies when they are known.
How will I be informed of the progress of my application?
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 can be contacted for updates on the progress of your evaluation.
During the course of the evaluation of your application we may need to contact you to clarify certain areas of the risk assessment . If we do so we will also 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 required information. We will inform you when we suspend the application. When we receive the required 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/ 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.
How will I be informed if additional information is required?
During the evaluation of your application we may need to request additional information, reasoned scientific cases or data. This additional information may be requested either as soon as your application is started or after we have completed its initial evaluation.
Only two requests for additional information will be sent. The first request will generally cover Chemistry, Toxicology, Residues and Fate and Behaviour. The second request will generally cover Operator Exposure, Ecotoxicology and Efficacy. 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, we would encourage you to contact us at an early stage and 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. The processing target will be adjusted by the time taken for you to provide a full response to the letter.
Full details of when we will accept data mid-evaluation can be found in the guidance submission.
What if I want to add more information to my application?
You may wish to provide additional data and/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 and/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 and/or information in support of your application, you should contact the Assessment Manager at the earliest opportunity. These requests are considered on a case-by-case basis and are at our discretion.
Further information on what additional information we will and will not accept can be found in the guidance on submitting additional data.
How can I withdraw my application?
You can withdraw your application at any time by contacting the Assessment Manager for the application. If your application has been accepted into the Admin Stream, you should write to the Pesticides Delivery Branch Applications Sift, Chemicals Regulation Division, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX.