SCHEDULE 1STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS
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Where—
a
the manufacturer’s licence relates to the assembly of a relevant medicinal product;
b
that medicinal product is not manufactured by the licence holder; and
c
particulars as to the name and address of the manufacturer of, or of the person who imports, that relevant medicinal product have been given by the licence holder to the licensing authority,
the licence holder shall forthwith notify the licensing authority in writing of any changes in such particulars.