SCHEDULES

SCHEDULE 8U.K.Material to accompany an application for a UK marketing authorisation

PART 1U.K.General requirements

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including—U.K.

(a)where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b)otherwise, a reference to the relevant chemical name.