Amendment of regulation 483

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;