The Applicant Guide: How Will My Application Be Processed?
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
How long will it take to get my authorisation and what are ‘streams’?
The processing times are related to those defined in Regulation (EC) No 1107/2009.
Full details of the application streams, processing targets and procedures for fast-tracking can be found in the guidance document 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’.
For new active substance and EU Review applications the target will be measured from the date the initial completeness check was finished.
If we need to contact you during the course of 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. The submission of additional data will also extend the target date for the completion of your application. In each case, 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 document 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 CRD 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
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.
The application form should include details of the formulation, technical specification and data lists as appropriate
Details of how to put together an application overview are given in the Applicant Guide.
- DATA - (summary of study subject area)
These should be titled 'DATA' followed by a few words to summarise the subject area.
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.
- OTHER - (brief description)
Other information such as previous correspondence should be titled 'OTHER' followed by a few words describing the document.
Nonylphenol, octylphenol statement
Where appropriate, the following phrase should also be included:
The approved formulation for <name of UK approved product> does not contain either Nonylphenol, NonylphenolEthoxylates, Octylphenol or OctylphenolEthoxylates. The proposed formulation for <name for proposed product> also does not contain any of these components.
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 more than 30 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 on CD submitted in the same format, together with the covering letter.
Further details of the documentation requirements for most applications is given in The Applicant Guide.
Applications must be emailed to [email protected] or sent to Pesticides 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. The information checked at this stage is outlined in "Overview of the Processes and Procedures for the Authorisation of Plant Protection Products -Appendix 3: Criteria for the validation check'.
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 entering 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:
- All zonal applications for new products
- Voluntary work share zonal applications for re-registration
- National assessments for new products and re-registration
- Applications for which the UK is a concerned Member State
- Mutual recognition applications
- All applications for which fast track status is requested
- 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 (e.g. 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 Overview of the Processes and Procedures for the Authorisation of Plant Protection Products - Appendix 4: Criteria for the detailed technical sift and this documents 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) No 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. As 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 hard copy or on CD) 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 "Completeness Checks" for new active substances
Applications for new active substances and EU Reviews undergo a 'completeness check', which is a detailed examination of the application. We will invoice you for your completeness check once your application is received, and inform you of the outcome of the check within 30 working days of receipt of the application.
If your application is not considered to be complete, you will have 15 working days to address the identified deficiencies. A further 15 working days after we receive the additional data and/or information we will inform you whether the application is considered complete.
If your application is considered complete, then we will send you another invoice for the full evaluation of your application and inform you of the processing target and the unique COP number. The evaluation process for your application will then commence.
If your application is not considered complete, or we do not receive further information, no further work will take place on your application.
When will my application be started?
Accepted product applications will be placed into the appropriate stream and started in queue date order. The Evaluating Officer 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 EU Review, the Project Manager will inform you of the start date. The Project Manager will also inform you of the intended meeting dates for the UK regulatory Committees and the processing target for completion of your application.
How will I be informed of the progress of my application?
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 another Member State 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.
If a new EC MRL, in Regulation 396/2005, is required before authorisation can be given, then your application will be completed as far as possible and an MRL application will be made to EFSA . At that point the application will be refused and you will be provided with details of the authorisation that could be granted once the MRL comes into force. A new 'administrative application' will need to be submitted to trigger the issue of the final authorisation once the MRL comes into force.
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 and detail any changes required to your product label. If your application was for authorisation of a new product or if the registration (MAPP) number for your existing product needs to change, we will also inform you of the new MAPP number.
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 Evaluating Officer or Project Manager in the first instance.
How will I be informed if additional information is required?
During the course of 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 CRD'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 Evaluating Officer 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 single 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 evaluation. 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 document.
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 Evaluating Officer or Project 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 document on submitting additional data.
How can I withdraw my application?
You can withdraw your application at any time by contacting the Evaluating Officer or Project Manager for the application. If your application has been accepted into the Admin Stream, you should write to the Pesticides Branch Applications Sift.
- The contents page for The Applicant Guide
- Guidance documents for The Applicant Guide
- Do I need to submit an application?
- What should I include in an application?
- What happens once my application is completed?
- How do I make changes to an authorisation?