SCHEDULES

SCHEDULE 4U.K.Standard provisions of licences under Part 3

PART 4U.K.Wholesale dealer's licence

Wholesale dealer's licence relating to special medicinal productsU.K.

34.  No later than 28 days prior to each importation of a special medicinal product, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—U.K.

(a)the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b)any trademark or the name of the manufacturer of the medicinal product;

(c)in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d)the quantity of medicinal product to be imported, which must not exceed the quantity specified in paragraph 38; and

(e)the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.