Regulation 3 Interpretation of Part 2

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.