SCHEDULEFees
Inclusion in Annex I to Council Directive 91/414/EEC, or the first approval in the United Kingdom for a product with a new active substance4
1
The fee for inclusion in Annex I to Council Directive 91/414/EEC (concerning the placing of plant protection products on the market12), or the first approval in the United Kingdom for a product containing a new active substance, is in accordance with the following table.
2
In this paragraph, “new active substance” means an active substance not previously used in a product approved in the United Kingdom.
Item | Application | Fee(£) |
---|---|---|
Where an active substance is neither a biocontrol agent nor a pheromone | ||
1 | Preliminary evaluation(2) of an application | 5,000 |
2 | Processing an application for provisional approval | 35,000 |
3 | Processing an application for the inclusion of an active substance in Annex I to Directive 91/414 | 35,000 |
4 | Evaluation of a full data package(3) | 105,000 |
5 | Evaluation of a partial data package(4): percentage of data provided— | |
5a |
| 15,000 |
5b |
| 30,000 |
5c |
| 40,000 |
5d |
| 60,000 |
5e |
| 80,000 |
5f |
| 105,000 |
Where an active substance is a biocontrol agent | ||
6 | Evaluation of a full data package and processing an application for provisional approval(3) | 22,500 |
7 | Processing an application for the inclusion of an active substance in Annex I | 7,500 |
8 | Evaluation of a partial data package: percentage of data provided(4) | |
8a |
| 5,500 |
8b |
| 11,250 |
8c |
| 17,000 |
8d |
| 22,500 |
Where an active substance is a pheromone | ||
9 | Evaluation of a full data package and processing an application for provisional approval (3) | 13,000 |
10 | Processing an application for the inclusion of an active substance in Annex I | 7,500 |
11 | Evaluation of a partial data package: percentage of data provided (4) | |
11a |
| 3,250 |
11b |
| 6,500 |
11c |
| 9,750 |
11d |
| 13,000 |
Notes | ||
(1) Application under regulation 4 or 7 of the 2005 Regulations excepting a subsequent application (i.e. an application under regulation 7 for approval of a product containing an active substance where there is already an approval for a product containing that active substance and the applicant has access to the data relating to the active substance in the approved product). | ||
(2) The initial evaluation carried out in order to notify the applicant whether his application can proceed further. | ||
(3) A full data package comprises the complete dossier called for by Annex II and Annex III to Council Directive 91/414/EEC to support one major representative use of one product. Where a data package also contains a large number of extra study reports submitted to refine risk assessments, to characterise metabolites or to support additional uses of the product then these studies will be treated as an additional partial data package. See also note (4). | ||
(4) The size of a partial data package is expressed as a percentage of a full data package. The percentage is estimated on the basis of the amount of time required to evaluate the data and to conduct the necessary risk assessments. The following are partial data packages—
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