Letters of access: authorisation of plant protection products and inclusion of adjuvants
This guidance relates to letters of access for applications for both the authorisation of plant protection products (PPP) and the inclusion of adjuvants on the official list available on the HSE Adjuvant database.
What is a letter of access?
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.
When is a letter of access required?
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:
- any active substance or formulation data that are being submitted with the application for the authorisation of your product that are owned by a third party
- any active substance, including that for different sources of the active substance, or formulation data that have been previously submitted and evaluated in support of the authorisation of your product. A letter of access to data owned by a third party is required even if those data were submitted and evaluated a number of years prior to the submission of your application. (see 'What is considered to be a valid letter of access' below for guidance on reusing previous letters).
Letters are not required for data which you own or data that are no longer protected under our data protection rules.
Letters may be 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.
What is considered to be a valid letter of access?
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 (for example for a particular time period, application or use). This may be in electronic format where the application is submitted electronically ; or,
- A photocopy of a previously submitted letter. This is only appropriate where the letter is sufficiently unrestricted (meaning it does not refer to a particular time period, application or use).
- Reference to a previous letter. Where a valid letter of access has previously been submitted (full details of the date of submission, product and COP number must be given).
The following information must be included in a valid letter of access:
- Details of the applicant. If the applicant is not the authorisation holder, details of the authorisation holder may also be included. If the authorisation holder is specified on the letter and changes during the course of an application for that product then we will request a new letter of access.
- Details of the product. This must include the tradename, and the MAPP registration number if available. If either change during an application we will request a new letter.
- Details of the data to which access is being granted. For example all data on a named active substance; all data on a named formulation; specific active substance and/or formulation data. If access is only being granted to specified individual studies, full details of these studies must be included.
- Commercial restrictions agreed between the companies. For example details of the specific application the letter has been given for; details of the active substance(s) in the product, the quantities of the active substance(s), uses of the product, application rates, details of the source of the active substance; whether a new letter is required for any future application.
In a valid letter of access you must not include restrictions on the commercial level of authorisation that may be granted for a product.
The letter must appear on headed paper and clearly originate from the data owner.
How can I withdraw access to data I own?
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.