Plant Protection Products (Fees) (Amendment) Regulations (Northern Ireland) 1997

Regulation 2

SCHEDULE

Regulation 3

“SCHEDULE Prescribed Fees

(1)	(2)
	Fee
Description of Service or Approval	amount	Old amount(1)
(c) Where an application is made for provisional approval of a plant protection product not already approved in another member State which contains an active substance not included in Annex I and that application is accompanied by an Annex I application relating to that active substance no fee is payable in relation to the first mentioned application.
(a) If the application is withdrawn before evaluation starts there will be refunded to the applicant an amount equal to 90% of the fee but with a minimum retention of £100.
(b) To justify this reduced fee the evidence supporting the application must be the same for all products included in the application.”
1.   Evaluation of an Annex I application or evaluation of an application for provisional approval— (a) where the application is a biocontrol agent or pheromone application ... ... ... ...	£13,700 (note (c))	(£13,400)
(b) where the application is not a biocontrol agent or pheromone application ... ... ... ...	£61,200 (note (c))	(£60,000)
2.   Preliminary examination and evaluation of a resubmitted Annex I application or preliminary examination and evaluation of a resubmitted application for provisional approval— (1) where it appears to the Department that there is no saving in costs or that such saving is less than 50%— (a) where the application is a biocontrol agent or pheromone application ... ... ... ...	£18,200 (note (c))	(£17,800)
(b) where the application is not a biocontrol agent or pheromone application ... ... ... ...	£65,700 (note (c))	(£64,400)
(2) where it appears to the Department that the saving in costs is not less than 50% but is less than 75% but the work which has to be done in relation to the application is significant— (a) where the application is a biocontrol agent or pheromone application ... ... ... ...	£9,100 (note (c))	(£8,900)
(b) where the application is not a biocontrol agent or pheromone application ... ... ... ...	£32,850 (note (c))	(£32,200)
(3) where it appears to the Department that the saving in costs is not less than 75% but the work which has to be done in relation to the application is significant—
(a) where the application is a biocontrol agent or pheromone application ... ... ... ...	£4,550 (note (c))	(£4,450)
(b) where the application is not a biocontrol agent or pheromone application ... ... ... ...	£16,425 (note (c))	(£16,100)
(4) where it appears to the Department that the saving in costs is so great that the work which has to be done in relation to the the application is not significant ... ... ... ...	£2,350 (note (c))	(£2,300)
3.   Preliminary examination and evaluation of an application under regulation 5 of the principal Regulations for approval of a plant protection product which is not already approved in another EEA State— (1) where the application is accompanied by data ... ... ... ...	£2,350 (note (a))	(£2,300)
(2) where the application is not accompanied by data— (a) where scientific examination is involved— (i) where the application relates to the intended importation into Northern Ireland of a plant protection product for use by the importer only and the product differs from another product already approved under regulation 5 of the principal Regulations in form only and not in substance	£290 (note (a))	(£285)
(ii) in any other case ... ... ... ...	£630 (note (a))	(£620)
(b) where no scientific examination is involved— (i) where the application relates to one product only ... ... ... ...	£285 (note (a))	(£285)
(ii) for each further product included in the same application ... ... ... ...	£10 (note (b))	(£10)
4.   Preliminary examination of an Annex I application or of an application for provisional approval (not being in either case a resubmitted application) ... ... ... ...	£4,500 (note (c))	(£4,400)
5.   Notification to an applicant following a preliminary examination that the application (an Annex I application or an application for any approval under the principal Regulations) was incomplete ... ... ... ...	£100	(£100)
6.   Evaluation of data submitted in compliance with a requirement or condition specified in a provisional approval, on each occasion data is submitted ... ... ... ...	£2,350 (note (a))	(£2,300)
7.   Extending the period of a provisional approval under regulation 7(5) of the principal Regulations ... ... ... ...	£630	(£620)
8.   Preliminary examination and evaluation of an application for an emergency approval under regulation 8 of the principal Regulations ... ... ... ...	£2,350 (note (a))	(£2,300)
9.   Preliminary examination and evaluation of an application for approval of a plant protection product for trial purposes under regulation 9 of the principal Regulations— (a) where the application is accompanied by data— (i) where evaluation of data is required in an area of risk assessment which has already been considered for the active substance in question ... ... ... ...	£1,650 (note (a))	(£1,600)
(ii) where evaluation of data is required in support of a new area of risk assessment for an active substance, or of a new active substance ... ... ... ...	£4,700 (note (a))	(£1,600)
(b) where the application is not accompanied by data— (i) where a case for extrapolation from an existing approval has been made ... ... ... ...	£1,400 (note (a))	(£1,600)
(ii) where no scientific examination is involved ... ... ... ...	£30	—
(c) where the application is for the renewal of an approval previously granted where the period for which it was granted has expired ... ... ... ...	£290 (note (a))	(£285)
10.   Preliminary examination and evaluation of an application under regulation 10 of the principal Regulations for an extension of approved use of a plant protection product already approved under regulation 5 of the principal Regulations— (a) where the application is a first application for the new use ... ... ... ...	£470 (note (a))	(£460)
(b) where the application is for the renewal of an extension where the period for which the extension was granted has expired ... ... ... ...	£150 (note (a))	(£145)
11.   Preliminary examination and evaluation of an application under regulation 11 of the principal Regulations for approval of a plant protection product, where the application relates to a plant protection product already approved in another EEA State	£1,650 (note (a))	(£1,600)
12.   Renewal under regulation 5(2) or (3) of the principal Regulations of an approval granted under regulation 5 of those Regulations— (a) where the application is accompanied by data ... ... ... ...	£2,350 (note (a))	(£2,300)
(b) where the application is not accompanied by data ... ... ... ...	£630 (note (a))	(£620)
13.   Modification under regulation 13(7) of the principal Regulations of any approval granted under those Regulations or of an extension of use granted under regulation 10 of the principal Regulations— (a) where the application is for one product only ... ... ... ...	£285 (note (a))	(£285)
(b) for each further product included in the same application ... ... ... ...	£10 (note (b))	(£10)
14.   Preliminary examination and evaluation of an application for the official recognition of a test facility or organisation as required by points 2.2 and 2.3 of the introduction to Annex III to the Directive(2)— (a) in connection with the application and inspection for official recognition of the test facility ... ... ... ...	£1,120 (note (a))	—
(b) in connection with re-inspection ... ... ... ...	£840 (note (a))	—

(1)

The figures in italics are the amounts of fees under these Regulations before the coming into operation of the Plant Protection Products (Fees) (Amendment) Regulations (Northern Ireland) 1997

(2)

Points 2.2 and 2.3 of the introduction to Annex III to the Directive were inserted by Annex II to Commission Directive 93/71/EEC (O.J. No. L221, 31.8.93, p. 27). Point 2.2 requires that the tests and analyses required under points 6.2 to 6.7 of section 6 to Annex III (efficacy data) be conducted by official or officially recognised testing facilities or organisations satisfying the requirements set out in point 2.2. Point 2.3 sets out requirements regarding the provision of information to verify compliance and inspections.