PART 2Capital Fees for Pre-Application Meetings

Interpretation of Part 23

In this Part—

  • “EU marketing authorisation” means—

    1. a

      a United Kingdom marketing authorisation granted by the licensing authority under Part 5 (marketing authorisations) of the Human Medicines Regulations;

    2. 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

    3. 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.