The Medicines (Products for Human Use) (Fees) Regulations 2016

Interpretation of Part 2U.K.

This section has no associated Explanatory Memorandum

3.  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.