SCHEDULES

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

PART 1General requirements

18

Where an application for authorisation for the medicinal product to be placed on the market is under consideration in a member State or States—

a

a list of the member State or States concerned; and

b

in relation to each application, a copy of—

i

the summary of the product characteristics proposed by the applicant, and

ii

the package leaflet proposed by the applicant.