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The Plant Protection Products (Fees) Regulations 2003
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- 2003 No. 660
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Regulation 2
SCHEDULETable of amounts payable for types of examination undertaken
| Item | Type of examination | Amount |
|---|---|---|
Notes (numbered) 1. Approval/extension applications comprise all cases not covered by item B or item C. 2. A Preliminary examination is the initial examination needed (in relation to applications other than Administrative Experimental applications and Off-label applications) in order to notify an applicant whether his application can proceed further. 3. An Administrative Experimental application is an application which would be an Experimental application but for the fact that it does not call for examination of data or of technical information. 4. An Administrative application is— (a) an application (other than an Administrative Experimental application) to make a change to an existing approval of a type which does not call for examination of data, label checking or detailed examination of technical information, or (b) an application by a prospective importer for approval of a product to be imported for personal use. 5. A Fast application is an application under regulation 5 (standard approvals), a subsequent application under regulation 7 (provisional approvals), or an application for a modification of either such approval under regulation 13(7)(b), of the 1995 Regulations of a type which calls for technical consideration or label checking, but not significant data examination. A subsequent application is an application under regulation 7 where there is already an approval for a product containing the active substance covered by the application and the applicant has access to data relating to the active substance covered by the approval in question. 6. A Parallel Import application is an application by a prospective importer for approval of a product to be imported for commercial use where the approval applied for relates to a product which is materially identical to a product identified in the application and already approved in the UK under the Control of Pesticides Regulations 1986(1) or the 1995 Regulations. 7. A Mutual Recognition application is an application under regulation 11 (mutual recognition of approvals), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations. 8. An Experimental application is an application under regulation 9 (approvals for research and development), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations which is not a Departmental application but which requires examination of data or technical information. 9. An Off-label application is an application for extension of an approved use under regulation 10, or for modification of such an extension under regulation 13(7)(b), of the 1995 Regulations of a type which calls for examination of data or detailed examination of technical information but is not a Departmental application. 10. A Normal application is— (a) an application under regulation 8 (emergency approvals), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations, or (b) an application under regulation 5 (standard approvals), a subsequent application (as described in Note 5) under regulation 7 (provisional approvals), or an application for modification of either such approval under regulation 13(7)(b), of the 1995 Regulations of a type which calls for significant data examination, that is not a Departmental application. 11. A Departmental application is an application under regulation 5, 8, 9 or 10 or a subsequent application (as described in Note 5) under regulation 7, of the 1995 Regulations of a type which calls for evaluation of data supplied by the applicant and referred to Government Departments other than the relevant authority. 12. A routine additional matter is a product or use change covered in the same application as a different product or different use change that calls for no additional examination. 13. Further examination is an examination in any case where the application is of a type which calls for examination by an expert on a matter covered by item A(4). 14. Product/active chemistry data are data to enable assessment of the technical specification of the active substance and the physico-chemical properties of the product. 15. Crop safety data are data supplied to show that the product does not adversely affect the treated crops, following crops or treated produce. The check is a minor one if only one aspect of crop safety is required to be addressed and it is required to confirm a finding deduced from other data, and otherwise it is a major one. 16. Parallel import verification is verification that a product to be imported is materially identical with a product approved under regulation 5 (standard approvals) or under regulation 7 (provisional approvals) of the 1995 Regulations. 17. This applies where a reasoned case for technical or scientific justification for an approval or a change to the conditions of an approval is provided instead of data for consideration of matters covered by item A (4) (a) (v). 18. Toxicology data are data used to assess the mammalian metabolism and toxicology of the active substance in the product and to determine the types of hazard to which the product can give rise. 19. Operator exposure additionally covers exposure of other persons resulting from the product use. 20. Residues/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. 21. Fate and behaviour in the environment covers the potential environmental exposure from product use, including the identity and quantity of active substance, metabolites, degradation products and reaction products which may be available in the soil, water or air and are of toxicological or environmental significance. 22. 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. 23. Effectiveness data are data (other than crop safety data) supplied to show that a product consistently controls the target pest. 24. Annex I application cases cover applications under regulation 4 (applications concerning active substances) or 7 (provisional approvals) of the 1995 Regulations with the exception of a subsequent application (as described in Note 5). 25. A full data package comprises the total dossier called for by Annex II, Annex III, or both, to the 1991 Directive, and percentages of it are based on the value of expert time called for in assessing a resubmitted application. 26. A resubmitted application is one where a previous application for approval has been unsuccessful, and a new application is made in an attempt to address all the concerns raised from that earlier application. 27. Annex III to the 1991 Directive requires that the tests and analyses of the efficacy data be conducted only by officially recognised testing facilities or organisations which are found to satisfy the requirements of the Directive following evaluation of their application and inspection of their facilities. | ||
Notes (lettered) A. If an application which falls entirely within this description could also fall within a description of another description of application, the fee payable remains the fee for this description of application. B. If the application is withdrawn after preliminary examination but before further activity in relation to the item starts, a fee of £100 is payable for processing the withdrawal. C. For any examination in a Departmental application in addition to the item fee, an additional fee £1,475 for each such matter is charged. D. Where further information is submitted in response to requests made by the Commission pursuant to Article 6 (4) of the 1991 Directive and the further information is required to be examined and evaluated in order to determine whether an active substance can be added to Annex I to that Directive, then an additional fee under item B (3), based on the size of the data package contained within that information, will become payable as if submission of that information were a resubmitted application. E. If the application is withdrawn after preliminary examination but before processing and evaluation, the fee in respect of the item is £5,000. F. The fee is payable where a person responsible for applying to another Member State for evaluation of a new active substance for inclusion in Annex I to the 1991 Directive requests the relevant authority to assist the other Member State with evaluation and scientific review. | ||
| In approval/extension application cases (Note 1): | ||
| Preliminary examination (Note 2) | £125 | |
| Basic examination of— | ||
(a) | an Administrative Experimental application (Note 3) | £30, |
(b) | an Administrative application (Note 4) | £70 (Note A) |
(c) | a Fast application (Note 5) | £1,060 (Note B) |
(d) | a Parallel import application (Note 6) | £710 (Note A) (Note B) |
(e) | a Mutual Recognition application (Note 7) | £1,060 (Note B) |
(f) | an Experimental application (Note 8) | £1,060 (Note B) |
(g) | an Off-label application (Note 9) | £470 (Note B) |
(h) | a Normal application (Note 10) | £1,750 (Note B) |
(i) | a Departmental application (Note 11) | £7,185 (Note B) |
| Examination of a routine additional matter (Note 12) in an Administrative application (Note 4) | £30 per matter | |
| Further examination (Note 13) comprising— | ||
(a) | Examination in any application which is not an Administrative or Administrative Experimental (Notes 3 and 4) application of any of the following: | |
(i) | label check | £425 |
(ii) | product/active chemistry data (Note 14) | £425 |
(iii) | crop safety data (minor) (Note 15) | £425 |
(iv) | parallel import verification (Note 16) | £200 |
(v) | text without data supporting a new approval or a change to the conditions of an approval in each of the following specialist areas (Note 17): | |
(aa)product/active chemistry (Note 14) | £350 (Note C) | |
(bb)toxicology (Note 18) | £350 (Note C) | |
(cc)operator exposure (Note 19) | £350 (Note C) | |
(dd)residues/consumer exposure (Note 20) | £350 (Note C) | |
(ee)fate and behaviour in the environment (Note 21) | £350 (Note C) | |
(ff)ecotoxicology (Note 22) | £350 (Note C) | |
(gg)crop safety and effectiveness (Notes 15 and 23) | £350 (Note C) | |
(b) | Applicable to Normal (Note 10), Experimental (Note 8) and Departmental (Note 11) applications: | |
(i) | data relating to residues/consumer exposure (Note 20) | £750 (Note C) |
(ii) | toxicology data (Note 18) | £750 (Note C) |
(iii) | data relating to operator exposure (Note 19) | £750 (Note C) |
(iv) | data relating to ecotoxicology (Note 22) | £750 (Note C) |
(v) | data relating to fate and behaviour in the environment (Note 21) | £750 (Note C) |
(vi) | effectiveness data (Note 23) | £750 (Note C) |
(vii) | crop safety data (major) (Note 15) | £750 (Note C) |
| In Annex I application cases (Note 24)— | ||
| Preliminary examination (Note 2) of an initial application | £5,000 | |
| Subsequent examination of an initial application comprising— | ||
(a) | where an active substance covered by an application is neither a biocontrol agent nor a pheromone, processing and evaluation of a provisional approval where application contains a full data package (Note 25) but does not call for other activity covered by item B (2) (b) | £95,000 |
(b) | where an active substance covered by an application is neither a biocontrol agent nor a pheromone, evaluation of an Annex I application (including any provisional approval for a product where requested as part of the application) and preparation of a draft assessment report and subsequent finalisation of that report as a result of discussions with all or any of the EC Commission, the European Food Safety Authority and other Member States | £110,000(NoteD) |
(c) | processing and evaluation in respect of a provisional approval or evaluation of an Annex I application for an active substance that is either a biocontrol agent or pheromone (including any provisional approval for a product where requested as part of the application) and preparation of a draft assessment report and subsequent finalisation of that report as a result of discussions with all or any of the EC Commission, the European Food Safety Authority and other Member States | £40,000 |
| Examination of a resubmitted application (Note 26) comprising— | ||
(a) | preliminary examination (Note 2), processing and evaluation where application contains 10% or less of a full data package (Note 25) | £26,000(Note E) |
(b) | preliminary examination (Note 2), processing and evaluation where application contains more than 10% but less than 25% of a full data package (Note 25) | £35,000(Note E) |
(c) | preliminary examination (Note 2), processing and evaluation where application contains at least 25% but less than 50% of a full data package (Note 25) | £53,000 (Note E) |
(d) | preliminary examination (Note 2), processing and evaluation where application contains at least 50% but less than 75% of a full data package (Note 25) | £71,000 (Note E) |
(e) | preliminary examination (Note 2), processing and evaluation where application contains 75% or more of a full data package (Note 25) | £90,000 (Note E) |
(f) | preliminary examination (Note 2), processing and evaluation in respect of an active substance which is either a biocontrol agent or pheromone | £20,000(Note E) |
| Evaluation and scientific review to assist another Member State regulatory authority with their evaluation of a new active substance for inclusion on Annex I | £10,000 (Note F) | |
| Preliminary examination and evaluation of an application for the official recognition of a test facility or organisation (Note 27)— | ||
| in connection with the application and inspection for initial official recognition of the test facility | £1,500 (Note B) | |
| in connection with the application and inspection for renewed recognition of the test facility | £1,500 (Note B) | |
| for each re-inspection following an inspection under item C (1) or (2) | £1,125 | |
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