This guidance document relates to letters of access for applications for both the authorisation of pesticide products and the inclusion of adjuvants on the Official List.
A letter of access allows us to use active substance and/or formulation data which are owned by a third party on your behalf. Access can be granted to specific studies or an entire data package.
The conditions of data access are a commercial matter between the companies concerned and may be reflected in the wording of the letter. We will not become involved in disputes between companies over data access but we will ensure that any letters that are submitted in support of individual applications are valid.
A valid letter(s) of access must be submitted with your application when any of the data that support your product's authorisation are owned by one or more third parties. These data include:
Letters are not required for data which you own or data that are no longer protected under our data protection rules.
Letters maybe submitted directly to us from the data owner although we prefer they are submitted by the applicant so that they are clearly linked with the application.
A valid letter of access can be either:
An original signed letter. This will be required for an application for a new product or where previous letters of access restricted access in some way (eg for a particular time period, application or use); or,
A photocopy of a previously submitted letter. This is only appropriate where the letter is sufficiently unrestricted (ie it does not refer to a particular time period, application or use).
The following information must be included in a valid letter of access:
The following information must not be included in a valid letter of access:
An example of a letter of access.
If you are a data owner and wish to withdraw access to data which supports a product that is currently authorised, you should write to us referencing the relevant product and letter of access. The product will continue to be authorised until the next application for that product is submitted. When we receive your letter we will write to the authorisation holder for the affected product informing them that access to the data has been withdrawn and, if necessary, remind them of their obligation to inform us of any changes to their product. When the next application for the product is submitted, we will check the data access bearing in mind the contents of your letter.