The Applicant Guide: Structure Of A Notice Of Approval

What does a Notice of Approval specify?

If your application for a commercial or experimental level of approval or Specific Off-Label Approval (SOLA) is successful, your approval documentation will consist of a letter and a ‘Notice of Approval’. The Notice of Approval will specify:

1. The governing legislation under which your application was evaluated and the level of approval you have received under that legislation. The Notice will also specify if your product is being given approval for advertisement, sale, supply, storage and use or a combination of these.
2. The product identity, including its tradename and registration (MAFF/MAPP) number.
3. If you receive a commercial level of approval, the details of your product’s formulation. These details include the formulation type, the quantity and identity of the active substance(s) in the formulation, a reference to the technical specification of the active substance(s) and a reference to the formulation ‘recipe’ for your product.

You can only market your product if it consists of this formulation and you must submit an application for approval if you wish to change your product’s formulation in any way.

If you receive a commercial level of approval for a ‘parallel import’, details of the product being sold in another Member State which you are importing into the UK.

4. The approval holder and marketing company for your product. If these are identical, the marketing company will not be specified.
5. Any relevant deadlines for the submission of data to address confirmatory data requirements, for products receiving provisional approval under The Control of Pesticide Regulations (as amended) 1986 (COPR). The accompanying letter will list the associated data requirements.
6. The relevant date of expiry for the approval.
7. If you receive an experimental approval, the amount of product that can be applied and the maximum area that can be treated on an annual basis.
8. If you receive a commercial level of approval, a reference to the product label. Unless your product is a parallel import, the accompanying letter will provide details of the changes required to the draft label submitted or referenced in your application in order that your product can be placed on the market in accordance with the approval and the underlying safety and efficacy assessment.

If you receive a commercial level of approval for a parallel import, details of any amendments that need to be made to your product’s label will be included in the approval.

9. If you receive a commercial level of approval, the size, material and design of the packaging approved for your product.
10. If you receive a commercial level of approval for a product considered under PPPR, details of any temporary Maximum Residue Levels that apply (see guidance document).
11. Details of any conditions of storage required for your product.
12. Details of any conditions of advertisement required for your product.
13. Details of the conditions of use for your product which will include:
    • The field of use. This will specify whether your product is approved for use by amateur or professional users, the general field of use and purpose for which the product is intended (e.g. use as an agricultural herbicide) and whether your product can be used in aerial application.
    • The crops and/or situations on which your product can be used.
    • If necessary, the maximum individual and maximum total doses for specific crops and/or situations.
    • If necessary, the maximum number of treatments for specific crops and/or situations.
    • If necessary, the latest time of application for specific crops and/or situations.
    • The requirements for the protection of users of your product.
    • The requirements for the protection of the environment with the use of your product.
    • Any other restrictions that need to be specified for the use of your product e.g. a maximum concentration for the use of your product on an individual crop.

14. Details of your obligations with regard to adverse data.
15. The COP number for your application.
16. A unique number for your Notice of Approval.
17. Details of any approvals superseded (or being replaced) by the new approval.
18. If your application is for a SOLA, advisory information on the use of the product under the SOLA.