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The Human Medicines (Amendment) (No. 2) Regulations 2014
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- Northern Ireland Statutory Rules
- 2014 No. 324
- Regulation 3
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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;”.
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