The Medicines (Products for Human Use) (Fees) Regulations 2012

Interpretation of Part 2

3.  In this Part—

“EU marketing authorization” means—

(a)

a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;

(b)

a marketing authorization 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 authorization; and

“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.