SCHEDULES
SCHEDULE 8Material to accompany an application for a UK marketing authorisation
PART 1General requirements
F118
Where—
a
in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—
i
a list of the member State or States concerned, and
ii
in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;
b
in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.