The Biocidal Products Regulations 2001

Regulation 39(1), (2) and (3)

SCHEDULE 12 FEES

1.  On the making of an application to the Ministers under regulation 5 for the inclusion of an active substance in Annex I, IA or IB, there shall be payable by the applicant to the Ministers—

(a) for ensuring that the dossiers submitted as part of that application satisfy the requirements of regulation 5 in accordance with regulation 6(1); and

(b) for determining the application in accordance with regulation 6(2),

a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

2.  There shall be payable by the applicant to the Ministers in connection with the determination of an application to the Ministers specified in paragraph 3, a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

3.  The applications to the Ministers referred to in paragraph 2 are—

(a) an application under regulation 7(1) for a variation of the requirements subject to which an active substance is included in Annex I, IA or IB;

(b) an application under regulation 7(2) for the renewal of the inclusion of an active substance in Annex I, IA or IB;

(c) an application under regulation 9 for the authorisation of, or the renewal of an authorisation of, a biocidal product;

(d) an application under regulation 10 for the registration of, or the renewal of the registration of, a biocidal product;

(e) an application under regulation 11(5) for the authorisation of a biocidal product;

(f) an application under regulation 12(5) for the registration of a biocidal product;

(g) an application under regulation 13 for the provisional authorisation of, or the renewal of the provisional authorisation of, a biocidal product;

(h) an application under regulation 14 for the provisional registration of, or the renewal of a provisional authorisation of, a biocidal product;

(i) an application for an authorisation under regulation 17.

4.  There shall be payable by the applicant to the Ministers in connection with the evaluation of dossiers following a decision referred to in regulation 6(6) or regulation 7(5), a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

5.  There shall be payable by a person who provides information under regulation 16(5) or 20(5)(b) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

6.  There shall be payable by a person who requests a modification under regulation 20(2) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

7.  On receipt of—

(a) an application referred to in paragraph 1;

(b) an application specified in paragraph 3;

(c) dossiers referred to in paragraph 4;

(d) information referred to in paragraph 5; or

(e) a request referred to in paragraph 6,

the Ministers shall prepare and send to the applicant, the person providing the information or the person making the request, as the case may be, an estimate of the cost of the work necessary for the determination of the application, the evaluation of dossiers, or the consideration of the information or the request.

8.  The amount estimated in accordance with paragraph 7 shall be paid forthwith by the person to whom the estimate is sent.

9.  On the determination of the application, completion of the evaluation of dossiers or consideration of the information or request, the Ministers shall prepare a detailed statement of the work carried out in relation to that determination, evaluation or consideration, as the case may be, and of the cost reasonably incurred by the Ministers or any person acting on their behalf in carrying out that work.

10.  If the cost referred to in paragraph 9 is greater than the amount estimated in accordance with paragraph 7, the amount of the difference shall be—

(a) notified by the Ministers to the applicant or the person providing the information or making the request, as the case may be;

(b) the amount of the final fee payable; and

(c) paid by the applicant or that person forthwith.

11.  If the cost referred to in paragraph 9 is less than the amount estimated in accordance with paragraph 7, the fee shall be adjusted accordingly and the amount of the difference shall be paid forthwith by the Ministers to the applicant or the person providing the information or making the request, as the case may be.

12.  In estimating or stating the cost of carrying out any work, the Ministers may take into account the cost to them, or to any person acting on their behalf, of employing an officer for any period to perform the work concerned and shall determine that cost by reference to the average cost of employing an officer of the grade appropriate for that work for that period.