Departmental

An application follows the Departmental procedure when an active ingredient is used in currently approved products within the same product type, but where the application differs from previous precedents, changing the risks of the product. These new risks will need to be assessed. For example, an increase in active ingredient concentration above that previously used i.e. above the precedent level, or if a product previously used indoors is now to be used outdoors.

The procedure for applying via the departmental route is the same for both in house and committee applications.

Applicants should submit a completed application form along with a draft label.

HSE considers the application and may request data to be submitted.
If data, previously submitted to HSE or PSD, is required to support this new application, but is still within data protection, then the applicant will need to request a letter of access from the owner of the data and include the letter of access in the application package. If a letter of access from the data owner cannot be obtained, then new data will have to be provided.

Other information may be required, for example, packaging details or safety data sheets.

Once the fee and all outstanding data and information are received, HSE can begin the evaluation. At this stage we request a copy of the draft label if one has not already been provided.

If the application is being dealt with via the committee route a report based on the evaluation by HSE is sent to the IDS which will assess technical aspects of the evaluation and in exceptional circumstances present its assessment to the ACP.

If consulted, the ACP considers the evaluation together with the IDS' views and then puts forward its recommendations to Government Ministers. Ultimately, the decision on granting approval rest with Ministers.

Once approval is granted applicants receive a Notice of Approval detailing the conditions associated with that approval.