Part IIIBiocidal Products

Frame-formulations

18.—(1) At the same time the Executive grants an authorisation in respect of a biocidal product under regulation 9 or 13, or grants a registration in respect of a biocidal product under regulation 10 or 14—

(a)it shall, when requested to do so by the applicant for that authorisation or that registration; or

(b)it may, without being requested to do so,

issue a frame-formulation which includes that biocidal product and it shall communicate that frame-formulation to that applicant.

(2) Where an application is made under regulation 9, 10, 13 or 14 in respect of a biocidal product within an issued frame-formulation, the Executive shall take that issued frame-formulation into account in evaluating the dossiers submitted with the application in question.

(3) Where a person makes an application for an authorisation under regulation 9 or 13 and that person has a letter of access in respect of the information relating to the biocidal products within an issued frame-formulation, the Executive shall decide whether or not to grant the authorisation within 60 days of its receiving the application.

(4) In this regulation, “issued frame-formulation” means a frame-formulation issued by the Executive in accordance with paragraph (1).