Regulatory Update: 49/2007
Issued: 20 December 2007
Since August 2002, it has been possible to submit applications for product approval in two stages. This allows PSD to accept certain data/information for consideration prior to the submission of the complete application. This route has proved very popular with applicants, and this Regulatory Update clarifies which type of applications can be considered this way, and explains slight changes to the procedures involved.
You should submit the first stage of the application to the Applications Sift (preferably submitted electronically) including:
- 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.
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. 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 (using the procedures outlined in Regulatory Update 7/2007).
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 approval. You will have 8 weeks to respond to this request. If no response is received within 8 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 within 8 weeks to the evaluating officer who evaluated the first stage. Ideally this should be submitted electronically and 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 (i.e. everything not considered in the first stage required to complete the application).
The second stage will be considered at the Applications Sift after which we will inform you whether the application has been accepted and invoice you for the work to be conducted in the second stage. The COP number for your application will not change. 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 (using the procedures outlined in Regulatory Update 7/2007.
Once the assessment of the second stage is completed, we will issue or refuse approval 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 approval 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 – note where data are submitted this will usually be the higher level fee (currently £1800). This is usually charged ‘up front’ with the first stage.
We will aim to complete the evaluation of the first stage of your application within 9 or 18 weeks from the date of acceptance (depending on the amount of data provided and noting that you may use a fast track option). 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.
We will aim to complete the evaluation of the second stage of your application within 9, 18 or 30 weeks from the date of acceptance of the second stage, depending on the amount of data provided (noting that the fast track option may be used in the first or second stage). You will be informed of the completion target after the sift.
What sort of data/information can be considered under the first stage?
This system is useful where your request for approval is critically dependent on the positive outcome of the assessment of data/information in a discreet area.
This will usually involve only one or two specialist areas.
- For example, you may wish to determine whether a source of active substance is technically equivalent to one approved under Control Of Pesticide Regulations 1986 (COPR) or to that considered for Annex I inclusion. This could be determined under the first stage with the submission of a technical specification, with supporting 5 batch data and complete analytical methods. The outcome of the first stage assessment would determine whether the source was technically equivalent, the second stage would consider the remainder of the active and product data requirements with a view to gaining approval for a product containing the new source.
- 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, or efficacy data for a product where rates will need to be reduced at re-registration. 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 approval for the product.
- You may wish to determine the equivalence of your Annex II data package compared to that considered in the EU review (for which protection is claimed). You may wish to do this in advance of official publication of the list of data, basing your comparison on the data list included with the Draft Assessment Report (DAR) published on the European Food Safety Authority (EFSA) website (recognising that the final list may change). This could be determined under the first stage with the submission of the data list given as a template in Annex III of the Commission Guidance document Sanco/10796/2003-rev8.0 on Re-registration. The outcome of the first stage assessment would determine whether your proposals for equivalence of studies or justification for non provision of studies were acceptable, and alert you to data gaps and allow you to negotiate access/generate studies at the earliest opportunity. The second stage would consider the remainder of the active and product data requirements with a view to gaining approval for the product. Given that there will be a need for both co-ordinator and specialist input, you should make it clear which areas of the assessment the data list covers with your submission, and be aware that we would charge a specialist data module in each area to allow cost recovery in each area of assessment.
If you have any questions relating to this Regulatory Update, please contact Tracy Roberts either by telephone 01904 455818 or email email@example.com