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

Extension application

4.

An extension application is an application—

(a)

for an extension of a marketing authorisation within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; and

(b)

which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.