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Amendment of regulation 48

3.  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;.