Two-stage application for pesticide product authorisation

The two-stage procedure is used where one aspect of the assessment can be concluded before progressing on to the remainder of the application.

Both the first stage and any second stage application submitted following successful completion of the first stage, are typically submitted under the same application and managed with the same target date. However, there can be exceptions as detailed below. In some cases, it may be necessary for a preparatory application to be completed first, so that key data can be assessed before the second stage is submitted as a new application.

For more information on general processes and procedures, refer to The Applicant Guide.

Examples of the two-stage procedure

• A new source of active substance to be included in a future new product.
  
  This is also known as a GB standalone technical equivalence application and you should complete the CRD 8 application form.
  
  A product must contain a source of active substance that has been evaluated as comparable/technically equivalent, to the source that was included in the approval of the active substance. For further information, refer to active substance source changes.
  
  For a new product containing a new source of active, the first stage of your application could request an assessment for technical equivalence of a new source. If, upon evaluation of the data, the source is considered to be technically equivalent, you will be informed and then have a specified period of time to submit the second stage of your application for the new product. In some cases, the second stage will be considered as a new application.
• Acceptability of a key study.
  
  For example, a mesocosm study for an active substance or product with known environmental concerns, or a storage stability study for a product with known storage problems.
  
  The first stage of your application could request assessment of the relevant study. The outcome of the first stage assessment will determine whether the study is acceptable. The second stage will consider the remainder of the product application (for example new product, amendment). In some cases, the second stage will be considered as a new application.

First stage

The first stage of the application should include the following:

• a covering letter fully explaining the purpose of your application and requesting consideration under the two-stage process
• clarification of who is applying and the address for invoicing
• the data and/or information necessary for the first stage evaluation

Note that an application form is not required at this first stage, except for a CRD8 form for GB 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 first stage. A COP number (job reference number) will be allocated and will remain with the application until completion of the second stage (unless the second stage is submitted as a new application). You should always reference this COP number when contacting us to discuss your application. A CRD contact will write to 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 and, where appropriate, ask you to submit the remaining data and/or information required for the second stage of your application.

You will have a specified period of time to respond to this request. If no response is received by the deadline, no further work will be carried out and the application will be closed. Any further information will need to be submitted in a new application (reference may be made to the outcome of the first stage of the previous application).

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.

Second stage

You should submit the second stage of the application by the specified deadline.

Submit it to the CRD contact for the first stage application and copy to ‘[email protected]’.

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 the second stage evaluation

Following the ‘applications sift’, we will inform you whether the application has been accepted and will invoice you for the work to be conducted in the second stage. We will advise you if a new application under a new COP number is required.

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.

Fees and timescales

First stage:

• sift fee
• appropriate specialist modules for the data/information submitted with the first stage
• co-ordination fee

You will be informed of the completion target after the ‘applications sift’.

Second stage:

• sift fee (a second sift fee applies in addition to the sift fee already charged at the first stage)
• appropriate specialist modules for the data/information submitted with the second stage, including a label check if required

Second stage considered as a new application:

If it is decided that the second stage needs to be considered as a new application you will be charged full fees.

• sift fee
• co-ordination fee
• appropriate specialist modules dependent on the data or other information submitted
• label check fee, if required