Regulation 3 Amendment of regulation 48

In regulation 48(2) (definitions in relation to the Part on marketing authorisations), after the definition of “generic medicinal product” insert—

• ““parallel import licence” means a licence that—

  1. (a)

     is granted by the licensing authority in compliance with the rules of European Union Law relating to parallel imports; and

  2. (b)

     authorises the holder to place on the market a medicinal product imported into the United Kingdom from another EEA State;”.