SCHEDULE 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 3PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

4

The holder of the authorisation shall—

a

inform the licensing authority before making any structural alterations to, or discontinuance of the use of, premises to which his authorisation relates; and

b

inform the licensing authority if he changes the person named as the qualified person for the purposes of regulation 43 and paragraph 9.