13.—(1) An application for approval of a plant protection product under regualtion 5, 7, 8 or 11 shall be made to the Ministers by or on behalf of the person responsible for first placing it on the market in Great Britain.
(2) For the purpose of any application for an approval under these Regulations or for an extension of use under regulation 10—
(a)the applicant shall have a permanent office within the EEA;
(b)the application shall be in English;
(c)samples of the preparation and of its ingredients shall be provided if requested by the Ministers.
(3) The Ministers may review an approval granted under regulation 5 or 7 or an extension of use granted under regulation 10 if there are indications that any of the relevant requirements are no longer satisfied.
(4) When reviewing an approval or extension of use under paragraph (3) above the Ministers may require the holder of the approval or extension of use to submit further information necessary for the review and the approval or extension of use may, where necessary, be extended for the period necessary to complete the review and provide such further information.
(5) Without prejudice to any decision already taken pursuant to regulation 11, the Ministers, in relation to any approval granted under these Regulations or extension of use granted under regulation 10—
(a)shall revoke the approval or extension of use if it is established that—
(i)the requirements for obtaining the approval or extension of use are not or are no longer satisfied; or
(ii)false or misleading particulars were supplied concerning the facts on the basis of which the approval or extension of use was granted;
(b)may revoke the approval or extension of use if it is established that any requirement or condition which is—
(i)specified in the approval or extension of use; or
(ii)required by the approval or extension of use to be on the labelling,is not or is no longer satisfied;
(c)may revoke the approval or extension of use at the request of the holder of the approval or the extension of use, who shall state the reasons for such a request.
(6) Where the Ministers revoke an approval or extension of use under paragraph (5) above, they shall immediately inform the holder of the approval or extension of use of such revocation and may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length commensurate with the reason for the revocation, without prejudice to any period provided for by a decision taken under Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances(1) as amended(2) or to Article 6(1) or 8(1) or (2).
(7) Without prejudice to any decision already taken pursuant to regulation 11 and subject to paragraph (8) below, the Ministers, in relation to any approval granted under these Regulations or extension of use granted under regulation 10—
(a)shall modify the approval or extension of use if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified;
(b)may modify the approval or extension of use at the request of the holder of the approval or the extension of use, who shall state the reasons for such a request.
(8) The Ministers may modify an approval or an extension of use under paragraph (7) above if it is established that the relevant requirements continue to be satisfied.
(9) In this regulation “the relevant requirements” means—
(a)in the case of an approval granted under regulation 5, the requirements of regulation 6(2) to (7);
(b)in the case of an approval granted under regulation 7, the requirements of regulation 6(3) to (7);
(c)in the case of an extension of use granted under regulation 10, the requirements of regulation 6(3)(c), (d) and (e).
OJ No. L33, 8.2.79, p.36.
Amended by the Act concerning the conditions of accession of the Hellenic Republic to the Economic Communities (OJ No. L291, 19.11.79, p.17); Commission Directive 83/131/EEC (OJ No. L91, 9.4.83, p.35); Commission Directive 85/298/EEC (OJ No. L154, 13.6.85, p.48); Council Regulation 3768/85/EEC (OJ No. L362, 31.12.85, p.8); Council Directive 86/214/EEC (OJ No. L152, 6.6.86, p.45); Council Directive 86/355/EEC (OJ No. L212, 2.8.86, p.33); Council Directive 87/181/EEC (OJ No. L71, 14.3.87, p.33); Commission Directive 87/477/EEC (OJ No. L273, 26.9.87, p.40); Council Directive 89/365/EEC (OJ No. L159, 10.6.89, p.58); Commission Directive 90/335/EEC (OJ No. L162, 28.6.90, p.37); Council Directive 90/533/EEC (OJ No. L296, 27.10.90, p.63); Commission Directive 91/188/EEC (OJ No. L92, 13.4.91, p.42).