The Applicant Guide: Submitting Additional Data and/or Information Mid-Evaluation
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
A request to make a minor change to an application once it has been acceptable is only acceptable if it falls within the criteria below, and the overall scope of the original application cannot be changed. We consider such changes on a case-by-case basis; and will depend on the stage we have reached with the evaluation of your application. You may also be asked to submit additional data mid-evaluation or as the second part of a 'two-stage' procedure to allow us to complete the evaluation of your application.
Changes to applications ('add tos')
We will consider changes in the following cases:
- Where it is a simple administrative change which would normally qualify as an Admin application (see the guidance document on submitting applications).
- When additional data/information/labels are submitted to support your original application. We only guarantee to accept this type of add-to if the evaluation of the application has not started.
Examples of acceptable changes are:
Changes in product name, authorisation holder and marketing company. If necessary, new letters of access that reflect the proposed change must be submitted. This change can be made up to the issue of an authorisation.
- A two year storage stability study that supersedes a previously submitted accelerated or one year study( only accepted prior to the start of the specialist evaluation of the application).
Revised labels that do not extend the scope (ie what the application is for) of the application. These must be submitted before the start of the evaluation of the application.
Additional convenience tank-mix recommendations supported by a Compatibility Assurance Statement (CAS). These may be accepted at any time as the CAS refers to an attached list of tank-mixes and no new label is submitted (see the guidance document on tank-mixes).
Additional tank mix recommendations supported by data. -only accepted before the start of the specialist evaluation of the application.
Minor formulation changes where new data are not required to support the change. Health and Safety Data Sheets and a reasoned scientific case to support the change must be submitted(only accepted before the start of the specialist evaluation of the application).
Revised efficacy or residues overviews as long as they do not extend the scope of the application(only accepted before the start of the specialist evaluation of the application).
- A final version of a report where the previously submitted draft version had not been signed by the QA department of the facility who conducted the report. These can only be accepted up to the completion of the specialist evaluation of the application.
But we will not consider the following changes:
- Any changes that would extend the scope of the application or alter it beyond what was requested when the application was submitted. Examples of altering the scope include requesting authorisation for additional crops; requesting an increase in the application rate, the number of treatments, or shortening the harvest interval; amending the classification of a proposed formulation.
- If the evaluation of the application is nearing completion so that it is no longer possible to consider your add-to request without a new evaluation eg we will not accept a revised efficacy overview if the efficacy evaluation for your application has been completed.
When can additional data or cases be submitted during the course of the application?
Additional data and/or cases can be submitted during evaluation to address any concerns raised that would result in the application being refused if they were not addressed (the 'data mid-evaluation' procedure).
These can only be accepted if additional information has not already been requested for your application, and where the scope of your application has not been changed eg data or case supporting an additional use or claim, or a change in GAP (Good Agricultural Practice), would not be accepted.
An additional fee will be charged to cover the cost of evaluating the additional data or case, based on the modules that need evaluating (see the guidance document on application fees).
Individual studies that need consideration in more than one specialist area will not be accepted eg environmental data on pesticide levels in water requiring evaluation by both our ecotoxicology and environmental fate and behaviour specialists could not be accepted. However, we will accept separate studies requiring consideration in more than one specialist area eg three ecotoxicology studies and one residues study, and would charge the appropriate specialist modules for these.
For applications submitted up to 28 June 2016 you will usually have eight weeks to respond to requests for additional information For applications submitted from 29 June 2016 you will usually have thirteen weeks to respond to requests for additional information. Additional studies should not be started if they will take longer than the deadline given to respond to the request for additional information.
Please note that the acceptance of additional data is entirely at our discretion and the submission of any additional data will not guarantee the successful evaluation of your