|
Notes (Numbered)
|
|
(1)
Application for approval under regulation 9 of the 2004 Regulations not involving examination of technical information or data (“technical consideration”).
|
|
(2)
Application for extension of approved use under regulation 10 or modification of such under regulation 13(7) of the 2004 Regulations which involves technical consideration but not consultation of Government Departments other than the Department.
|
|
(3)
Application for approval under regulation 5, 7, 9 or 11, or an extension of approved use under regulation 10, or modification of such under regulation 13(7), of the 2004 Regulations involving no technical consideration.
|
|
(4)
Application for approval for personal use only of an imported product, materially identical to a product approved under the Plant Protection Products Regulations 2003 and the 2004 Regulations or the Control of Pesticides Regulations 1986 and the Control of Pesticides Regulations (Northern Ireland) 1987 (“a UK approved product”).
|
|
(5)
Where the application relates to a number of different products, this charge applies to each additional product.
|
|
(6)
Application for approval of an imported product, materially identical to a UK approved product, for uses extending beyond personal use.
|
|
(7)
Application for approval under regulation 11, or modification of such under regulation 13(7), of the 2004 Regulations, involving technical consideration.
|
|
(8)
Application for approval under regulation 9, or modification of such under regulation 13(7), of the 2004 Regulations, which involves technical consideration but not consultation of Government Departments other than the Department.
|
|
(9)
Application for approval under regulation 5, 7 or 8, or modification of such under regulation 13(7), of the 2004 Regulations, which involves technical consideration but not consultation of Government Departments other than the Department.
|
|
(10)
Application for approval under regulation 5, 7, 8 or 9, or extension of approved use under regulation 10 or modification of such under regulation 13(7), of the 2004 Regulations which calls for technical consideration and consultation of Government Departments other than the Department.
|
|
(11)
Verification that the product to be imported is materially identical to a UK approved product.
|
|
(12)
Product/active chemistry covers assessment of the technical specification of the active substance in the product and the physico-chemical properties of the product.
|
|
(13)
Toxicology covers assessment of the mammalian metabolism and toxicology of the active substance in the product and determination of the types of hazard to which the product can give rise.
|
|
(14)
Operator exposure additionally covers exposure of other persons resulting from the product use.
|
|
(15)
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.
|
|
(16)
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.
|
|
(17)
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.
|
|
(18)
Effectiveness covers the assessment of whether a product consistently controls the target pest. Crop safety covers the assessment of whether the product adversely affects the treated crops, following crops or treated produce. Consideration is minor if it covers no more than confirmation of a finding reached previously following examination of data submitted in the course of an earlier application and extension of an approval under the 2004 Regulations to additional crop varieties; otherwise it is major.
|
|
(19)
For any application under item A(5) withdrawn after preliminary examination under A(3) but before further activity in relation to the item starts.
|
|
(20)
Application under regulation 4 (applications concerning active substances) or 7 (provisional approvals) of the 2004 Regulations excepting a subsequent application (i.e. an application under regulation 7 for approval of a product containing an active substance where there is already an approval for a product containing that active substance and the applicant has access to the data relating to the active substance in the approved product).
|
|
(21)
The initial examination carried out in order to notify the applicant whether his application can proceed further.
|
|
(22)
A full data package comprises the complete dossier called for by Annex II or 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.
|
|
(23)
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.
|
|
(24)
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)
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.
|
|
(B)
If the application is withdrawn after preliminary examination but before commencement of processing and evaluation, the fee in respect of the item is £5,000.
|
|
(C)
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.
|
|
(D)
If the application is withdrawn after preliminary examination but before further activity in relation to the item starts the fee in respect of the item is £100.
|
| A | | In cases not covered by item B or C – | |
| (1) | | Administrative experimental application | £30 |
| (2) | | Off-label application including administration, co-ordination and technical consideration | £470 |
| (3) | | Preliminary examination of application type listed in item A(4) or (5) to determine whether application can proceed further | £125 |
| (4) | (a) | Administrative application for new product or change to a single existing product | £120 |
| (b) | Additional products included in an administrative application | £40 |
| (5) | | Co-ordination of application for new product or change to existing product: | |
| (a) | Parallel import | £710 |
| (b) | Mutual Recognition | £1,060 |
| (c) | Experimental approval | £1,060 |
| (d) | Other application (involving no specialist data examination in any of items A(9)(c) to (i)) | £1,060 |
| (e) | Other application (involving specialist data examination in any of items A(9)(c) to (i)) | £1,750 |
| (f) | Departmental application | £7,185 |
| (6) | | Examination of a label in any application | £300 |
| (7) | | Parallel import verification | £200 |
| (8) | | Examination of technical information other than data in any application in each of the following specialist areas: | |
| (a) | Product/active chemistry | £250 |
| (b) | Toxicology | £250 |
| (c) | Operator exposure | £250 |
| (d) | Residues/consumer exposure | £250 |
| (e) | Fate and behaviour in the environment | £250 |
| (f) | Ecotoxicology | £250 |
| (g) | Crop safety, effectiveness or both | £250 |
| (9) | | Examination of data in any application in each of the following specialist areas: | |
| (a) | Product/active chemistry | £425 |
| (b) | Crop safety, effectiveness or both (minor consideration) | £425 |
| (c) | Toxicology | £750 |
| (d) | Operator exposure | £750 |
| (e) | Residues/consumer exposure | £750 |
| (f) | Fate and behaviour in the environment | £750 |
| (g) | Ecotoxicology | £750 |
| (h) | Crop safety (major consideration) | £750 |
| (i) | Effectiveness (major consideration) | £750 |
| (10) | | Reference of technical information under item (8), or data under item (9), to Government Departments other than the relevant authority. | £1,475 |
| (11) | | Withdrawal processing | £100 |
| B | | In Annex I application cases – | |
| (1) | | Preliminary examination of an initial application | £5,000 |
| (2) | | 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 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 |
| (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 |
| (3) | | Examination of a resubmitted application (in respect of an active substance which is neither a biocontrol agent nor a pheromone) comprising – | |
| (a) | Preliminary examination, processing and evaluation where application contains 10% or less of a full data package(22) | £26,000 |
| (b) | Preliminary examination, processing and evaluation where application contains more than 10% but less than 25% of a full data package | £35,000 |
| (c) | Preliminary examination, processing and evaluation where application contains at least 25% but less than 50% of a full data package | £53,000 |
| (d) | Preliminary examination, processing and evaluation where application contains at least 50% but less than 75% of a full data package | £71,000 |
| (e) | Preliminary examination, processing and evaluation where application contains 75% or more of a full data package | £90,000 |
| (4) | | Examination of a resubmitted application comprising preliminary examination, processing and evaluation in respect of an active substance which is either a biocontrol agent or pheromone | £20,000 |
| (5) | | 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 |
| C | | Preliminary examination and evaluation of an application for the official recognition of a test facility or organisation – | |
| (1) | | in connection with the application and inspection for initial official recognition of the test facility | £1,500 |
| (2) | | in connection with the application and inspection for renewed recognition of the test facility | £1,500 |
| (3) | | for each re-inspection following an inspection under item C(1) or (2) | £1,125 |