Phased submission: new pesticides active substance application
Phased submission is available on an application for the first approval of a new active substance. It allows for pre-application evaluation of studies to improve efficiency of the regulatory process. It is optional and subject to agreement by HSE.
Benefits of phased submission
When compiling regulatory dossiers for new active substances, many studies are available in advance of the application date.
Longer term, higher-tier studies and risk assessments are the steps that most affect the formal application date. HSE may consider the submission of the studies for evaluation before formal application for approval is submitted.
Pre-approval submission is limited to hazard evaluation and endpoint determination, not risk assessment, due to the incomplete dossier.
The phased submission approach should help to:
- provide more certainty on endpoints for the application risk assessment
- allow early identification of areas that may need further consideration before finalising the application
- support global harmonisation by making early study evaluations available to work share partners
This method should reduce the number of post-application technical questions and requests for revision. It may also reduce the time from formal application to production of the draft assessment report (DAR).
Phased submission process
To begin a phased submission, once you have identified your active substance, contact HSE with your proposal.
Your proposal should:
- provide background on the active substance and the intended date for the formal application
- identify the studies for the pre-application submission
- propose the submission date (this could be a year or more before the intended formal application date)
- show that enough studies are available to support the evaluation process
- identify remaining studies to be submitted with the formal application
HSE will accept the proposal based on:
- the extent of the pre-application submission if a sufficient body of studies is available to justify the approach
- proposed dates of pre-application submission and the formal application
If the proposal is acceptable the next step is a meeting on the submission details and project timelines.
The pre-application submission should:
- use the framework of the OECD dossier format
- include document M study summaries
- contain a reference list and an endpoint list
The partial dossier fee structure will apply and will be charged immediately after HSE receive the pre-application submission. The formal application will then include an additional 'completeness check' fee.
The total fee for the pre-application evaluation and the complete dossier supporting the formal application uses more resources and so is higher than for the evaluation of a core dossier alone.