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.
The first stage of the application should include the following:
- a covering letter fully explaining the purpose of your application and that you seek consideration under the two-stage process
- clarification of who is applying and the address for invoicing
- the data and/or information necessary for evaluation of the first stage (see below)
Note that an application form is not required at this stage. However, application form CRD8 must be submitted for standalone technical equivalence assessments.
- Following the applications sift, we will inform you whether the first stage has been accepted and invoice you for the work to be conducted in the initial stage. A COP number will be allocated that will remain with the application until the completion of the second stage unless the second stage requires a detailed technical sift. You should always reference this COP number when contacting us to discuss your application. The assessment manager will contact you once the assessment of the first stage commences. We may seek clarification of some issues during the assessment of the first stage This is detailed under The applicant guide: How will my application be processed.
- Once the assessment of the first stage is completed, we will inform you of the outcome of that part of the evaluation and where appropriate ask you to submit the remaining data and/or information required to allow the complete assessment of your application for authorisation.
- You will have 13 weeks to respond to this request. If no response is received within 13 weeks no further work will be carried out on the application. Once the application has been closed, any further information will require a new application (although reference may be made to the outcome of the first stage of the previous application).
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:
- a covering letter referencing the first stage assessment COP number, and summarising what information is to be considered in the second stage (the remainder of the application)
- completed application form (CRD1)
- The data and/or information necessary for evaluation of the second stage
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:
- sift fee
- appropriate specialist modules for the data information submitted with the first stage
- co-ordination fee
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:
- sift fee (note: two sift fees apply)
- appropriate specialist modules for the data/information submitted with the second stage, including a label check if appropriate