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The Plant Protection Products (Fees and Charges) Regulations 2011
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Fees related to application for approval of basic substances
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4. The fees for work involved in assisting an applicant in preparing or submitting an application for approval of a basic substance under Article 23 of Regulation 1107/2009 are in accordance with the following table.
| Item | Application | Fee(£) | ||
|---|---|---|---|---|
| Notes | ||||
(1) A full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance. 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, these studies will be treated as an additional partial data package. See also note (2). | ||||
(2) The size of a partial data package is banded as a proportion 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. Applicants will be notified of the appropriate Band prior to an evaluation taking place. Partial data packages include one or more of the following — (a) additional data over and above a ‘standard’ core dossier, for example, situations where there are significantly more metabolites, or very large novel studies to be evaluated; (b) additional study submissions during evaluation required to clarify the initial dossier; (c) resubmissions, for example, where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission; (d) data to support a change to the conditions of approval of the basic substance; (e) joint evaluation where the United Kingdom and one or more other Member States share the evaluation of the dossier; | ||||
| The evaluation of scientific peer reviewed open literature on the basic substance and its relevant metabolites is treated as a partial data package. | ||||
| 1 | Assistance with a full data package(1) | 110,000 | ||
| 2 | Assistance with a partial data package(2): | |||
| Band 1 | 7,500 | |||
| Band 2 | 15,000 | |||
| Band 3 | 30,000 | |||
| Band 4 | 50,000 | |||
| Band 5 | 70,000 | |||
| Band 6 | 90,000 | |||
| Band 7 | 110,000 | |||
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