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

12.  Where—

(a)the manufacturing authorisation relates to the assembly of an investigational medicinal product;

(b)that investigational medicinal product is not manufactured by the holder of the authorisation; and

(c)particulars as to the name and address of the manufacturer of, or of the person who imports, that investigational medicinal product had been given by the holder of the authorisation to the licensing authority,

the holder of the authorisation shall forthwith notify the licensing authority in writing of any changes in such particulars.