Step 4: Evaluation

Within 12 months of the application submission, HSE will evaluate the information and prepare a draft assessment report (DAR). The DAR will include whether the active substance meets the approval criteria provided in Article 4 of retained Regulation 1107/2009 ( website).

If HSE require additional studies or information required, a time period will be set for you to supply the information. This will be a maximum of 6 months. The evaluation period will be extended for HSE to evaluate the additional information.

HSE charges a fee for the evaluation.

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Updated 2023-10-02