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

The fee for an application for extension of authorised use received before 1^st 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.

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

Application for a parallel trade permit for personal use only.

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

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

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.

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

Application in accordance with Article 30 of Regulation 1107/2009 for a provisional authorisation in the United Kingdom (not exceeding 3 years) for a plant protection product containing a new active substance for which a decision on approval has been delayed by more than 30 months from the date of admissibility of the original application.

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. 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, these studies will be treated as an additional partial data package. See also note (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—

1. 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;

2. b

   additional study submissions during evaluation required to clarify the initial dossier;

3. c

   resubmissions, for example, where the previous application for approval or inclusion in Annex 1 to Directive 91/414/EEC15 or for approval or renewal of 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;

4. d

   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;

5. e

   data to support the evaluation of an active substance under Regulation 1107/2009 once the initial period of inclusion in Annex 1 of Directive 91/414/EEC has expired. The full dossier is not required just additional data to demonstrate compliance with any new guidance, regulations or scientific advances;

6. f

   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 standard fees specified in the product-related application fees table (paragraph 1, items 9a-g above).

7. g

   Additional studies submitted to support an adverse data review.

Article 29(3) of Regulation 1107/2009 requires that compliance with certain authorisation requirements is established by official or officially recognised tests and analyses.

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).

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 —

1. 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;

2. b

   additional study submissions during evaluation required to clarify the initial dossier;

3. 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;

4. d

   data to support a change to the conditions of approval of the basic substance;

5. e

   joint evaluation where the United Kingdom and one or more other Member States share the evaluation of the dossier;