PART 6U.K.MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

Application for manufacturing authorisationU.K.

38.—(1) An application for the grant of a manufacturing authorisation shall be—

(a)made to the licensing authority;

(b)in writing; and

(c)signed by or on behalf of the applicant.

(2) Every application for the grant of a manufacturing authorisation shall specify which, if any, of the standard provisions referred to in regulation 40(4) it is desired shall be excluded or modified in relation to the grant of the authorisation.

(3) [F1Subject to paragraph (3A), every] application for the grant of a manufacturing authorisation shall be accompanied by—

(a)the particulars specified in Schedule 6 to these regulations; and

(b)any fee which may be payable in connection with that application under the [F2Medicines (Products for Human Use) (Fees) Regulations 2016].

[F3(3A) No fee need accompany an application for the grant of a manufacturing authorisation where arrangements have been made with the licensing authority for the payment of the fee referred to in paragraph (3)(b) other than at the time of the application.]

(4) The application and any accompanying material shall be supplied to the licensing authority in the English language.

Textual Amendments