SCHEDULE 7 U.K. STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 2 U.K. PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS

6.  The holder of the authorisation shall— U.K.

(a) inform the licensing authority before making any material alteration in the premises or plant used under his authorisation, or in the operations for which they are used; and

(b) inform the licensing authority of any change that he proposes to make in any personnel named in his authorisation as respectively—

(i) responsible for supervising the production operations, or

(ii) responsible for quality control of the investigational medicinal products being manufactured or assembled including the person named as the qualified person for the purposes of regulation 43 and paragraph 14.