Paragraph 11
Where—
(a)
the manufacturer's licence relates to the assembly of a medicinal product;
(b)
the medicinal product is not manufactured by the licence holder; and
(c)
particulars of the name and address of the manufacturer of the product, or the person who imports the product, have been given by the licence holder to the licensing authority,
the licence holder must immediately notify the licensing authority in writing of any changes in the particulars.