Applicant Guide: Two-Stage Applications

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

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. For example, 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. The data would be considered by our Human Health Branch and, if acceptable, you will be informed and then given 8 weeks to submit the second stage of your application.

When the second stage of your application is received it will then be considered at the sift, and once accepted, you will be sent an invoice for the appropriate modules. Your application would be placed into the appropriate processing stream and you will be informed of the appropriate processing target. Once the evaluation of your application is completed you will be informed of the outcome and will receive either an authorisation or a letter detailing the reasons why the application has been refused.

First Stage

The first stage of the application should be submitted to the Applications Sift (preferably electronically) and 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.

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).

Second stage

You should submit the second stage of the application within 8 weeks to the same 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 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 – 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 an authorisation 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.

1. 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. All requests for technical equivalence assessments of new sources of active substances must be supported by 5 batch data, methods of analysis and validation data and also details of the method of manufacture. It would be helpful if you could submit a draft Technical Equivalence report in addition, however this is not a requirement. 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 an authorisation for a product containing the new source.
2. 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 an authorisation for the product.