SCHEDULE 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

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

5

The holder of the authorisation shall provide such information as may be requested by the licensing authority for the purposes of these Regulations or the Act—

a

about the products currently being manufactured or assembled under his authorisation; and

b

of the operations being carried out in relation to such manufacture or assembly.