
1 

(1) These Regulations may be cited as the Plant Protection Products (Fees) Regulations (Northern Ireland) 2004 and shall come into operation on 21st October 2004.
(2) In these Regulations –
 “1991 Directive” means Council Directive 91/414/EEC concerning the placing of plant protection products on the market amended as set out in the definition of “the Directive” in the 2004 Regulations;
 “the 2004 Regulations” means the Plant Protection Products Regulations (Northern Ireland) 2004;
 “data” means scientific evidence submitted in support of an application under the 2004 Regulations; and
 “the Department” means the Department of Agriculture and Rural Development.
(3) The Interpretation Act (Northern Ireland) 1954 shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.
2 

(1) An applicant under regulation 4 (active substances) or 10 (extensions) of, or for an approval under, the 2004 Regulations shall pay a fee to the Department in accordance with this regulation.
(2) The following persons shall also pay a fee in accordance with this regulation –
(a) a person making a request under regulation 13(7)(b) (modifications) of the 2004 Regulations,
(b) a person making a request to the Department for initial or the renewed official recognition of a testing facility under paragraph 2.2 or 2.3 of Annex III to the 1991 Directive, and
(c) a person covered by Note C in the Schedule,
and for the purposes of these Regulations such persons shall be treated as applicants and their requests as applications.
(3) The fee is the total of the amounts specified within the Table set out in the Schedule, as read with the notes, for each type of examination or related activity called for by the application, but if a lower sum (following consideration of actual work involved in examining any relevant application) is notified as the fee by the Department to the applicant then the fee is the lower sum.
(4) Payment shall be made in accordance with any invoice for the fee (or the balance) sent to the applicant by the Department, and the Department shall be under no obligation to process the application so long as there is a failure to make any such payment.
(5) On completion of all examinations and related activities involved in processing the application, any difference between what has been paid and the fee shall be paid or refunded.
(6) Any amount due under this regulation but unpaid is recoverable upon a demand in writing being sent to the person from whom it is due.
(7) In any proceedings relating to an application under these Regulations, a certificate of the Department as to the amount payable in connection with the application shall be evidence of the amount in question.
3 

(1) Subject to paragraph (2) these Regulations shall not apply in respect of any application made before the date on which these Regulations come into operation.
(2) The amount of any fee relating to any activity carried out on or after the date on which these Regulations come into operation in connection with any application made before the date on which they come into operation is based on the fee specified in these Regulations.
4 

(1) The Plant Protection Products (Fees) Regulations (Northern Ireland) 1995 and the Plant Protection Products (Fees) (Amendment) Regulations 1997 are hereby revoked.
(2) The Regulations referred to in paragraph (1) shall continue to have effect in relation to any services provided or approvals granted by the Department (within the meaning of those Regulations) before the date on which these Regulations come into operation as if these Regulations had not been made.
Sealed with the Official Seal of the Department of Agriculture and Rural Development on 27th August 2004.
D. Small
A senior officer of the
Department of Agriculture and Rural Development

SCHEDULE
Regulation 2


Item Type of examination Amount
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
Notes (Numbered)
























Notes (Lettered)



