3. In this Part—
“EU marketing authorization” means—
a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;
a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
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.