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Applicant Guide: Two-Stage procedure

A two-stage procedure involves the submission of the data and/or information supporting the evaluation of your application in two stages.

Applications are processed under Article 33 of Regulation (EC) 1107 with a 52-week target that covers stage 1 and any stage 2 application that is submitted following completion of the first stage. For standalone technical equivalence applications the application form CRD 8 should be completed. Details of the processes and procedures for the authorisation of plant protection products (PPP) are outlined.

When might I use the two-stage procedure?

This system is useful where your request for authorisation is dependent on a certain aspect of the required evaluation being successful.

You may wish to gain authorisation for a new product containing a new source of active substance based on the extrapolation of active substance-related data supporting another source of the active substance. For such an application to be successful, it is essential that your source is comparable to the approved source to allow the extrapolation of the appropriate data.

For the first stage of your application you could request an assessment for technical equivalence of a new source. If the data is acceptable, you will be informed and then given 13 weeks to submit the second stage of your application.

You may wish to determine the acceptability of a key study, for example a mesocosm study for a product with known environmental concerns, or a storage stability study for a product with known storage problems. This could be determined under the first stage with the submission of the relevant study alongside a description of the concerns. The first stage must only require consideration in one risk assessment area or where one is dependent on another such as ecotoxicology relying on outputs from the environmental fate assessment. The outcome of the first stage assessment will determine whether the study is acceptable, the second stage will consider the remainder of the active and product data requirements. However, where the product contains a new active substance and/or the submission requires consideration by the detailed technical sift then the second stage will be considered as a new application.

First stage

The first stage of the application should include the following:

Note that an application form is not required at this stage. However, application form CRD8 must be submitted for standalone technical equivalence assessments.

Second stage

You should submit the second stage of the application by the deadline specified by HSE to the same assessment manager who evaluated the first stage. This should include:

We will inform you whether the application has been accepted at the applications sift and invoice you for the work to be conducted in the second stage.

We may seek clarification during the assessment of the second stage. This is detailed under The applicant guide: How will my application be processed. Once the assessment of the second stage is completed, we will issue or refuse authorisation according to our usual procedures.

Please be aware that a positive outcome of the first stage of your application does not guarantee the issuing of an authorisation for your product after the second stage or later.

Fees and timescales

For the first stage the fees will include the following:

The processing time of the application depends on the date of submission and acceptance. You will be informed of the completion target after the applications sift.

For the second stage the fees will include the following:

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Updated 2021-02-16