PART 2Capital Fees for Pre-Application Meetings
Interpretation of Part 23.
In this Part—
“EU marketing authorisation” means—
(a)
a United Kingdom marketing authorisation granted by the licensing authority under Part 5 (marketing authorisations) of the Human Medicines Regulations;
(b)
a marketing authorisation granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
(c)
a European Union marketing authorisation; and
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.