SCHEDULES

SCHEDULE 2Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 1General: interpretation and categories of applications and variations

Simple application17

A simple application is an application—

a

for a marketing authorisation to which Article 10c of the 2001 Directive applies; or

b

made no later than three months after the expiry of a marketing authorisation, which is for a marketing authorisation containing identical provisions to those contained in the expired authorisation and which is made by the person who held the expired authorisation.