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—
- a
is granted by the licensing authority in compliance with the rules of European Union Law relating to parallel imports; and
- b
authorises the holder to place on the market a medicinal product imported into the United Kingdom from another EEA State;