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:

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:

HSE will accept the proposal based on:

If the proposal is acceptable the next step is a meeting on the submission details and project timelines.

The pre-application submission should:

Fees

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.

HSE fees

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Updated 2022-11-28->->->