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[F1SCHEDULE 1U.K.Fees

Textual Amendments

Fees for application and evaluation of an active substance, safener [F2, synergist or basic substance] U.K.

2.  The fees [F3chargeable by a Great Britain competent authority] for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener [F4, synergist or basic substance], are in accordance with the following table.

ItemApplicationFee(£)
Where an active substance, safener [F5, synergist or basic substance] is neither a biocontrol agent nor a pheromone
1Preliminary evaluation(1) of the admissibility of an application5,200
2F6. . .F6. . .
3 [F7Co-ordination of scientific advice and public consultation and finalising the draft assessment report]36,400
4Evaluation of a full data package(3)114,400
5Evaluation of a partial data package(4):
Band 17,800
Band 215,600
Band 331,200
Band 452,000
Band 572,800
Band 693,600
Band 7114,400
Where an active substance is a biocontrol agent
6Evaluation of a full data package (3)23,400
7 [F8Co-ordination of scientific advice and public consultation, and finalising the draft assessment report]7,800
8Evaluation of a partial data package(4):
Band 15,720
Band 211,700
Band 317,680
Band 423,400
Where an active substance is a pheromone
9Evaluation of a full data package(3)13,520
10 [F8Co-ordination of scientific advice and public consultation, and finalising the draft assessment report]7,800
11Evaluation of a partial data package:(4)
Band 13,380
Band 26,760
Band 310,140
Band 413,520
For all evaluations
12Meeting before the submission of an application in support of a new active substance, safener, synergist, [F9basic substance,] biocontrol agent or pheromone5,200

Notes

(1) The initial evaluation carried out in order to notify the applicant whether his or her application can proceed further.

F10(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) [F11In relation to active substances, safeners or synergists,] a full data package comprises the complete dossier (the information referred to in paragraphs 1 and 2 of Article 8 of Regulation 1107/2009) to support one or more representative use of one product. [F12In relation to basic substances, 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 of the product [F13or basic substance], these studies will be treated as an additional partial data package. See also note (4).

(4) The size of a partial data package is banded as a proportion of a full data package. The proportion 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;

F14(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)[F15 in relation to active substances, safeners or synergists,] data to support the extension of the approval of an active substance, safener or synergist under Regulation 1107/2009 once the initial approval period has expired or to change the conditions of approval during the approval period;

F16(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)[F17in relation to active substances, safeners or synergists,] large data packages in one or more areas of the risk assessment that have been submitted in support of product related applications (e.g. re-registration and new product applications under Regulation 1107/2009) that significantly exceed the size for which the standard fees specified in the product-related application fees table (paragraph 1, items 9a-g above) are payable.

(g)[F17in relation to active substances, safeners or synergists,] additional studies submitted to support an adverse data review.

[F18(h)in relation to basic substances, 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);

(i)in relation to basic substances, data to support a change to the conditions of approval of the basic substance.]

[F19The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.]]

Textual Amendments