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 submitted from 29 June 2016 will be processed under Article 33 of Regulation (EC) No 1107/2009. The basic principles outlined below will still be applicable, but note a decision on the second stage will be delivered within 52 weeks. For standalone technical equivalence applications the application form CRD 8 should be completed. Details of the processes and procedures for the authorisation of PPP are outlined.
Overview of the operation of the process and procedures for the authorisation of PPP in the UK from 29 June 2016.
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 submit five batch analysis data in support of your new source to allow a comparison to the existing 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 outcome of the first stage assessment would determine whether the study was acceptable, the second stage would consider the remainder of the active and product data requirements with a view to gaining an authorisation for the product.
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, an application form should be submitted for standalone technical equivalence assessments submitted from 29 June 2016; the application form CRD8 should be completed.
- Following the 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. You should always reference this COP number when contacting us to discuss your application. The evaluating officer 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 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 then no further work will be carried out on the application.
- Any further information would be considered under 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 CRD to the same evaluating officer 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;
- The data and/or information necessary for evaluation of the second stage
We will inform you whether the application has been accepted at the Sift and invoice you for the work to be conducted in the second stage. The evaluating officer will contact you once the assessment of the second stage commences.
We may seek clarification during the assessment of the final 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 & 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. You will be informed of the completion target after the 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.
For applications submitted up to 28 June 2016 we will aim to complete the evaluation of the second stage of your application within 12, 30 or 52 weeks from the date of acceptance of the second stage, depending on the amount of data provided. For applications submitted from 29 June 2016 the second stage will be completed within 12 months. You will be informed of the completion target after the sift.