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The Plant Protection Products (Fees and Charges) Regulations 2011

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This is the original version (as it was originally made).

Fees for application and evaluation of a plant protection product for authorisation

This section has no associated Explanatory Memorandum

1.  Fees for product-related applications are in accordance with the following table, and each item is charged cumulatively.

ItemChargeable itemFee(£)
Notes
(1)

Application for authorisation under Regulation 1107/2009 not involving evaluation of technical information or data.

(2)

The fee for an application for extension of authorised use received before 1st April 2012 is £1,495. The fee for an application for extension of authorised use received on or after 1st April 2012 is £1,700.

(3)

Application for authorisation under Regulation 1107/2009 involving no technical consideration.

(4)

Application for a parallel trade permit for personal use only.

(5)

Where the application relates to a number of different products, this charge applies to each additional product.

(6)

Application for a parallel trade permit for other than personal use.

(7)

Verification that the product to be traded is identical to a product authorised in the part of the United Kingdom to which the application relates in accordance with Regulation 1107/2009.

(8)

“Standard technical stream applications” are all applications other than items 1-5, 10, 11 and 12.

(9)

The co-ordination of applications for new products or a change to an existing product.

(10)

Chemistry covers assessment of the technical specification of the active substance, safeners and synergists in the product and the physico-chemical properties of the product.

(11)

Toxicology covers assessment of the mammalian metabolism and toxicology of the active substance, safeners and synergists in the product and determination of the types of hazard to which the product can give rise.

(12)

Operator exposure additionally covers exposure of other persons resulting from the product use.

(13)

Consumer exposure covers exposure of consumers resulting from consumption of produce from treated crops, treated produce or products derived from either, including products from animals to which any such matter has been fed.

(14)

Fate and behaviour in the environment covers the potential environmental exposure from product use, including the identity and quantity of the active substance, metabolites, degradation products and reaction products, safeners and synergists which may be available in the soil, water or air and are of toxicological or environmental significance.

(15)

Ecotoxicology covers the assessment of the potential impact on non-target species likely to be at risk from exposure to the product, including the active substance, and toxicologically or environmentally significant metabolites, degradation products and reaction products, safeners and synergists.

(16)

Efficacy covers the assessment of whether a product consistently controls the target pest and whether the product adversely affects the treated crops, following crops or treated produce.

(17)

Pre-submission meetings may be held at the request of the applicant prior to the submission of an application to the United Kingdom to act as lead zonal rapporteur.

(18)

A Zonal surcharge is applied to any new product or re-registration application for which the United Kingdom has been requested to act as the Central Zone lead Member State. This fee covers the additional co-ordination and evaluation work required to support approvals in other Member States over and above what is required in the United Kingdom. Zonal surcharge 1 is the minimum additional fee applied. Zonal Surcharge 2 is applied for any use or uses required in another Member State but not in the United Kingdom. For particularly complex protocols requiring significant specialist input it may be necessary to charge a data module fee in the relevant specialist area.

(19)

The fee is equivalent to a specialist case fee and relates to requests from applicants for the United Kingdom to comment on the study design in advance of the data being generated and an application being submitted. For particularly complex protocols requiring significant specialist input it may be necessary to charge a data module fee in the relevant specialist area.

1Administrative research and development application(1)50
2Extension of use application including administration, co-ordination and technical consideration

1,495 or

1,700 (2)

3Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further220
4Administrative application(3)(4) for a new product or change to an existing product—
4aone product150
4beach additional product(5)50
5Parallel trade applications—
5aco-ordination of application for a new product or change to an existing product involving parallel trade(5)700
5bparallel trade verification(7)200
6Evaluation of a label in any application200
7Co-ordination of standard technical stream applications (9) (9)1,800
8Evaluation of simple reasoned cases in each of the following specialist areas—
8achemistry(10)400
8btoxicology(11)400
8coperator exposure(12)400
8dresidues and consumer exposure(13)400
8efate and behaviour in the environment(14)400
8fecotoxicology(15)400
8gefficacy(16)400
9Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—
9achemistry(10)750
9btoxicology(11)750
9coperator exposure(12)750
9dresidues and consumer exposure(13)750
9efate and behaviour in the environment(14)1,800
9fecotoxicology(15)1,800
9gefficacy(16)1,800
10Withdrawal of an application for a product specified in items 2, 4, 5, 7, 12 or 13 before any work other than preliminary consideration has been done100
11Pre-submission meetings for lead zonal re-registration and new product applications(17)5,000
12Zonal surcharge for lead zonal re-registration and new product applications. This fee is in addition to those described in 7 to 9 above (18)
Zonal surcharge 17,500
Zonal surcharge 215,000
13Commenting on draft study protocols(19)400

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