The process of a zonal authorization for a plant protection product involves several steps and timelines.

1. Submission of the Application:
– The applicant submits the application for authorization to a designated member state within the desired regulatory zone.
– The application includes the necessary data, documentation, and supporting information required for evaluation.

2. Preliminary Assessment and Validation:
– The designated member state (Zonal Rapporteur Member State or ZRMS) conducts a preliminary assessment of the application within 30 days of its submission.
– The zRMS checks the completeness and validity of the application and requests any missing or additional data from the applicant.
– If the application is deemed incomplete or invalid, the applicant is notified and given a reasonable period (usually 30 days) to provide the requested information.

3. Zonal Procedure:
– Once the application is deemed complete and valid, the zonal procedure begins.
– The zRMS takes the lead in coordinating the evaluation process with other member states within the same regulatory zone (concerned member states or cMS).

4. Evaluation by the zRMS and cMS:
– The zRMS and cMS evaluate the application based on the provided data and information.
– The evaluation covers various aspects, including safety, efficacy, risk assessment, and environmental impact.
– The zRMS and cMS may request additional data or clarifications from the applicant during the evaluation process.

5. Draft Assessment Report:
– Within 120 days from the start of the zonal procedure, the zRMS prepares a draft assessment report.
– The draft assessment report summarizes the findings of the evaluation, including conclusions on the product’s safety, efficacy, and potential risks.

6. Consultation and Comments:
– The draft assessment report is shared with the cMS for their review and comments.
– The cMS have 60 days to provide their input and raise any concerns or additional data.

7. Final Assessment Report:
– After considering the comments from the cMS, the zRMS finalizes the assessment report.
– The final assessment report includes the zRMS’s conclusions and recommendations regarding the authorization of the plant protection product.

It’s important to note that the specific timelines mentioned above are approximate and can vary depending on various factors, including the complexity of the product, availability of data, and any additional requirements or discussions during the evaluation process.