How long will it take to get my approval and what are ‘streams’?
We have a series of ‘processing time targets’ for the completion of applications that we evaluate varying from one to 48 weeks, depending on the application type and the amount of work involved in the evaluation. Details can be found in our Business Plan. We aim to complete at least 90% of applications within published processing targets.
For product applications considered by our Registration Branch, the processing targets relate to the ‘stream’ into which the application is placed. Some applications can be ‘fast‑tracked’. This means that they will be dealt with within a shorter processing time, although this option is limited to only certain application types and one application per approval holder per financial year.
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 (which is calculated from the date of acceptance). For new active substance and EU Review applications considered by our Registration Branch your processing 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 off-label approvals for further information);
- The inclusion of adjuvants on the Official List;
- The production of certificates of free‑sale;
- The consideration of adverse data.
For new active substance and EU Review applications considered by our Registration Branch there are a range of fees reflecting the level of consideration required and the procedural steps involved with the application. For product applications considered by our Registration Branch, the fees are based on a modular system with each element of the work (module) being charged separately. The total charge therefore reflects the work involved for that specific application.
We will evaluate applications as soon as they have been accepted but we will not issue any approval until the fee is fully paid. For most applications you will be invoiced once the application is accepted, although for applications for Administrative Experimental Approvals we require the fee to be paid at the same time as the application is submitted (see the guidance document for experimental approvals).
No refund is made if the application is refused.
See the guidance document for full details of the application fees and how to pay them.
Where do I submit my application?
Applications for commercial and experimental approvals, Specific Off-Label Approvals, import tolerances and for the inclusion of adjuvants on the Official List should be submitted in either of the following ways:
Emailed to applications@hse.gsi.gov.uk or sent to Registration Branch Applications Sift, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX.
For further guidance on Emailed applications see Regulatory Update : 23/2005.
What happens after I submit my application?
Applications submitted to CRD are considered at a weekly ‘Registration Branch 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. We do not carry out a detailed consideration of the data and/or information provided. To ensure your application is considered at the sift we must receive it either via email or as a hard copy by midday (12pm) the previous Thursday. Any applications received after midday (12pm) will be considered at the sift a week on Tuesday.
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 within three working days of the sift being completed. 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.
Applications for new active substances and EU Reviews undergo a ‘completeness check’, which is a more detailed examination than the sift. You will be invoiced for your completeness check once your application is received and informed of the outcome of the check within 30 working days of the 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 the receipt of the additional data and/or information you will be informed whether the application is considered complete.
If your application is considered complete then you will be sent another invoice for the full evaluation of your application and informed of the processing target and the unique COP number. Once it has been accepted, the evaluation process for your application will commence. If your application is not considered complete or further information is not received, no further work will take place on your application.
When will my application be started?
Applications accepted to be processed via the Secretariat procedure 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 its completion.
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.
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 MS in order for the application to proceed then we will suspend your application until the required information is received. 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 approval can be given then your application will be suspended until the new MRL is in place. You will be informed of this suspension. Once the required MRL is in place the application will be completed.
We will inform you when we have completed the evaluation of your application. If an approval 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 approval 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 your application is to be refused 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 further 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 one request for further information will be made in each area of the risk assessment. It will be CRD's responsibility to 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. We will usually ask you to provide the required information within 8 weeks of each individual request for 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 receiving a suitable reply from you will be added to the processing target for the application.
If you cannot provide the required information within the eight week 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 adding 5 weeks to the existing processing target plus the time taken for you to provide a full response to the letter. You will be informed of the revised processing target for your application.
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 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.
Procedures for the processing of applications
During the course of your application we will consult internally on the acceptability of the data, reasoned scientific cases and/or information submitted in support of your application. Occasionally we will consult organisations outside CRD such as other government departments, Advisory Committees and the European Commission.
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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 Registration Branch Applications Sift.
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